Sr. Manager - Quality Assurance
Lilly job in Durham, NC
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
**Position Overview:**
Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced Quality Assurance Manager to support our growth in Research Triangle Park state-of-the-art facility production site. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.
**Position Description:**
The Manager/Senior Manager, Quality Assurance is responsible for providing leadership and technical oversight for the formulation, filling, and visual inspection areas to ensure compliance with regulatory requirements, corporate standards, and industry best practices.
This role combines people management with technical quality expertise, driving team structuring, collaborators development, continuous improvement of regulated processes, documentation, and operational readiness.
The Manager/Senior Manager will help build a strong quality culture, lead inspection readiness, and provide ongoing operational support.
**Job Responsibilities:**
+ Build and manage a functional QA organization that supports operational excellence, lean practices, and shopfloor presence.
+ Lead, mentor, and coach QA floor teams, fostering a culture of safety, quality, compliance, and continuous improvement.
+ Establish and monitor performance objectives, providing feedback and coaching to drive team development.
+ Identify business and quality risks, escalating appropriately and in a timely manner.
**Technical Responsibilities:**
+ Provide continuous quality improvement oversight to regulated processes, practices, and documentation.
+ Review and approve GMP documentation, including procedures, deviations, technical reports, and change controls to ensure compliance with Lilly Global Quality Standards and regulatory requirements.
+ Network with global and parenteral sites to share best practices, improve processes and resolve product-related issues.
+ Work cross-functionally with process teams for metrics reviews, operational support, and deviation management.
+ Provide guidance and share technical knowledge in operational areas to ensure robust Quality Systems and GMP compliance.
+ Participate in inspections from regulatory agencies and corporate audits, and manage responses to findings.
+ Ensure compliance with corporate, local, and regulatory agency policies, procedures, and guidelines.
+ Provide QA oversight of formulation, filling operations using isolator technology, and visual inspection processes.
+ Lead or participate in non-routine investigations, root cause analysis, and corrective/preventive actions.
**Minimum Requirements:**
+ Bachelor's or Master's degree in Engineering, Life Sciences, or related field.
+ 7+ years of experience in Quality Assurance, with at least 3 years in a leadership role.
+ Demonstrated strong experience and proficiency with pharmaceutical manufacturing and working knowledge of Quality Management Systems and applicable regulatory requirements.
+ Demonstrated attention to detail and ability to maintain quality systems.
+ Previous experience leading or working effectively with a cross-functional group.
+ Demonstrated excellent interpersonal, written and oral communication skills.
+ Demonstrated strong technical aptitude and ability to train and mentor others.
+ Demonstrated decision making and problem-solving skills.
+ Demonstrated ability to organize and prioritize multiple tasks.
**Additional Preferences:**
+ Previous experience with highly automated parenteral manufacturing processes including isolators, automated inspection, etc.
+ Previous experience with Manufacturing Execution Systems and electronic batch release.
+ CQM, CQE, or CQA certification from the American Society for Quality (ASQ).
+ Previous experience with Trackwise, Veeva, MODA.
**Additional Information:**
+ The normal schedule for this position is Monday-Friday, 8 hours/day. However back-up for floor QA teams and planned shutdown support may require support outside the normal schedule.
+ Support for 24/7 manufacturing operations.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$94,500 - $151,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
\#WeAreLilly
Technician - Process Quality Assurance Floor Support (Night Shift)
Lilly job in Durham, NC
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Eli Lilly RTP is a new state of the art Parenteral, Device Assembly, and Packaging Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to be part of Team Lilly and work with the latest formulation, isolator, and visual inspection technology.
The Quality Assurance Floor Support Specialist works as a member of the QA Floor Support team and reports to the QA Floor Support Supervisor. Responsibilities include providing QA oversight to GMP operations in the Parenteral equipment preparation, formulation, filling, and visual inspection areas. The QA Floor Support Specialist oversees production functions to achieve site goals while providing Quality oversight and ensuring compliance.
**Job Responsibilities:**
+ Responsible for adhering to safety rules and maintaining a safe work environment for both ones-self and others by supporting HSE corporate and site goals.
+ Responsible for ensuring training is completed and remains in compliance.
+ Communicates with Quality Specialist Lead and QA Floor Support Supervisor on quality and operational issues.
+ Ensures adherence and understanding of good documentation practices and compliance with applicable procedures for both Operations and Support personnel.
+ Advise Operations and support personnel on quality matters, while driving the site Quality culture.
+ Ensures regular presence in assigned parenteral areas to monitor aseptic behaviors, GMP programs and quality systems.
+ Reviews and approves GMP documentation in support of daily operations such as: electronic batch record logs, paper logbooks, cleaning, and procedures versus performance.
+ Performs daily documented Quality Checks.
+ Perform sample collection, inspection, and delivery of samples to storage location and/or laboratory.
+ Troubleshoot and provide QA systems support to reconcile issues in systems, such as, inventory control systems (SAP), laboratory LIMS system (Darwin) and other systems as required (TrackWise. PMX).
+ Participate in self-led inspections and provide support during internal / external regulatory inspections.
+ Ability to work cross functionally and work collaboratively with all levels of the organization.
**Basic Requirements:**
+ High School Diploma or equivalent
+ Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
+ Completion of Post Offer Exam or Completion of Work Simulation if applicable.
+ Ability to work overtime, as requested.
**Additional Preferences:**
+ Demonstrated strong oral and written communication and interpersonal skills.
+ Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study, preferred.
+ Demonstrated knowledge and understanding of pharmaceutical process and Quality Systems.
+ Knowledgeable with inventory management systems and deviations systems, (i.e. SAP, TrackWise, etc.)
+ Previous work with combination products or devices with experience with US/EU regulations and notified bodies.
+ Previous experience in GMP production environments.
+ Previous facility or area start up experience.
+ Knowledge of Validation / Qualification activities.
+ Demonstrated decision making and problem-solving skills.
+ Strong attention to detail
+ Proven ability to work independently or as part of a team to resolve issues.
**Additional Information:**
+ Night shift: The position will support a 24/7 operation, working a rotating twelve (12) hour day shift schedule. During the onboarding phase, role will work eight (8) hours Monday-Friday day shift, then transition to the rotating twelve (12) hour day shift stated above upon approval from Supervision.
+ Applicant may work in various areas within the DAP and Warehouse buildings. Mobility requirements should be considered when applying for this position.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$18.02 - $38.61
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
\#WeAreLilly
Financial Advisor
Queensbury, NY job
This job posting is anticipated to remain open for 30 days, from 01-Dec-2025. The posting may close early due to the volume of applicants. If you find yourself at a professional crossroads, a career as a financial advisor may be the right change for you. Financial advisors partner with clients to help them achieve their long-term financial goals: retirement, building wealth, estate strategies, funding education and more. As a financial advisor with Edward Jones, you'll develop and grow your own practice, supported by your branch team, a home-office team and other regional financial advisors. You'll benefit from the experience that comes from 100 years of history. We're proud to have more offices in the U.S. and Canada than any other investment firm, serving over eight million clients.
Our financial advisors are valued partners, and we credit much of our success to their unique experiences and professional backgrounds. We value an inclusive environment where everyone's different viewpoints help to achieve results. Financial advisors lead the branch team to serve clients and contribute to the firm's purpose. They deeply understand the client's goals and why they are important to accelerate trust and help them stay on track. Edward Jones helps you positively impact clients' lives and work together to achieve their long-term financial goals, enabling you to make a difference in your community.
We'll give you the support you need. Our team will be there every step of the way, providing:
Paid training - Get registered and licensed and learn how to be a financial advisor with the industry's top training program¹.
Salary for the first five years as you begin to build your practice²
A firm-provided branch office in the community
Branch office support to help lighten the load so you can focus on your clients
A support network that extends from your branch office to your region to the home office - You'll work independently, but will have a team of thousands backing you every step of the way.
You can also expect...
No ceiling to your earning potential and growth, and your compensation is tied to the effort you put in
A compensation package that includes opportunities for commissions, profit sharing and incentive travel
The flexibility that you need to balance your personal and professional lives - the best of both worlds
A culture of continuous improvement and professional development
Key Responsibilities
Build relationships to create new clients via face-to-face and virtual sourcing strategies (residential, business, networking, introductions and referrals, social media, and speaking engagements).
Deeply understand clients' and prospective clients' needs, priorities, and concerns to accelerate trust and create personalized, comprehensive strategies to help them achieve their goals.
Oversee branch processes, roles, and responsibilities to ensure a high-quality, streamlined client experience consistent with firm policies and procedures, regulatory requirements, and ethical guidelines.
Engage the branch team to create, monitor, and adjust the branch business plan to increase branch effectiveness and achieve desired business results.
Create a highly engaging environment in the branch of mutual trust, respect, feedback and accountability.
¹ For the 25th consecutive year, Edward Jones was named a top company for training. The firm ranked No. 17 on Training magazine's prestigious 2025 Training APEX awards listed by Training magazine. 2025 Training Magazine Training Apex Award, published February 2025, date as of September 2024, an application fee was required for consideration
² As your new asset compensation and commissions increase over the first five years, salary will decrease
Benefits:
Edward Jones' compensation and benefits package includes medical and prescription drug, dental, vision, voluntary benefits (such as accident, hospital indemnity, and critical illness), disability income continuation, basic life, and basic AD&D coverage. Income continuation, basic life, and basic AD&D coverage are provided at no cost to financial advisors. Edward Jones offers a 401k retirement plan, and tax-advantaged accounts: health savings account and flexible spending account. Financial advisors enjoy flexibility in their schedule and, where required by applicable law, are eligible for paid sick leave and paid time off. Financial advisors may be eligible for bonuses; profit sharing; paid medical and parental leave for Financial Advisors that satisfy eligibility requirements; and participation in the firm's Travel Award Program. All associates are eligible for the firm's Employee Assistance Program. For more information on the Benefits available to financial advisors, please visit our benefits page.
Compensation:
We know that building a business takes time, so we've built a new financial advisor compensation program that supports and rewards you as you learn the skills, systems and business practices you need to succeed in our client-first business model. The new financial advisor compensation program includes trainee pay, a supplemental salary for up to five years, commissions and compensation for new assets gathered for the first five years.
For more information regarding compensation please click the link below.
New Financial Advisors Compensation
Supplemental Starting Salary Range $45,000 - $100,000
Read More About Job Overview
Skills/Requirements
Successful financial advisors demonstrate a unique combination of ambition, self-motivation, and commitment to establishing long-term client relationships. Financial advisors grow the business through identifying and creating new clients through initial discover of financial goals and deepening relationships with existing clients by reviewing investment strategies and implementation recommendations. Financial advisors earning potential is reflective of their performance.
What characteristics would make you a successful financial advisor?
An interest in financial services/markets and how they work
Love of learning and challenges, including determination to succeed
Skilled in long-term relationship building
Comfortable in your ability to think critically
Passion for new opportunities
Can you see yourself...
Learning to be a financial advisor through our comprehensive training program?
Delivering personalized investment and financial solutions to your clients?
Taking ownership of your business's growth and success?
Meeting professional and personal objectives as they relate to building your practice?
Working in and positively impacting your local community?
Skills/Requirements
Candidates should have at least one of the four qualifications bullets listed below:
A bachelor's degree is strongly preferred or equivalent work-related experience within the securities/financial services industry
Financial services and/or sales experience
Financial services registration, licensing, or certification
Professional and/or military career progression
Licensing:
SIE (which can be obtained without Firm sponsorship), Series 7 and Series 66 will be required; if not currently registered, registrations may be obtained at Edward Jones during the assigned paid study period.
FINRA registrations required within three months. State insurance licenses will be required.
As an associate, you are required to complete ongoing training offered by the firm and regulatory authorities (FINRA and SEC), as well as required CE training to ensure licenses remain in good standing.
Read More About Skills/Requirements
Awards & Accolades
At Edward Jones, we are building a place where everyone feels like they belong. We're proud of our associates' contributions to the firm and the recognitions we have received.
Check out our U.S. awards and accolades: Insights & Information Blog Postings about Edward Jones
Check out our Canadian awards and accolades: Insights & Information Blog Postings about Edward Jones
Read More About Awards & Accolades
About Us
Join a financial services firm where your contributions are valued. Edward Jones is a Fortune 500¹ company where people come first. With over 9 million clients and 20,000 financial advisors across the U.S. and Canada, we're proud to be privately-owned, placing the focus on our clients rather than shareholder returns.
Behind everything we do is our purpose: We partner for positive impact to improve the lives of our clients and colleagues, and together, better our communities and society. We are an innovative, flexible, and inclusive organization that attracts, develops, and inspires performance excellence and a sense of belonging.
People are at the center of our partnership. Edward Jones associates are seen, heard, respected, and supported. This is what we believe makes us the best place to start or build your career.
View our Purpose, Inclusion and Citizenship Report.
¹Fortune 500, published June 2024, data as of December 2023. Compensation provided for using, not obtaining, the rating.
Edward Jones does not discriminate on the basis of race, color, gender, religion, national origin, age, disability, sexual orientation, pregnancy, veteran status, genetic information or any other basis prohibited by applicable law.
#LI-USFATA
Financial Advisor
Mountain Lakes, NJ job
This job posting is anticipated to remain open for 30 days, from 03-Dec-2025. The posting may close early due to the volume of applicants. If you find yourself at a professional crossroads, a career as a financial advisor may be the right change for you. Financial advisors partner with clients to help them achieve their long-term financial goals: retirement, building wealth, estate strategies, funding education and more. As a financial advisor with Edward Jones, you'll develop and grow your own practice, supported by your branch team, a home-office team and other regional financial advisors. You'll benefit from the experience that comes from 100 years of history. We're proud to have more offices in the U.S. and Canada than any other investment firm, serving over eight million clients.
Our financial advisors are valued partners, and we credit much of our success to their unique experiences and professional backgrounds. We value an inclusive environment where everyone's different viewpoints help to achieve results. Financial advisors lead the branch team to serve clients and contribute to the firm's purpose. They deeply understand the client's goals and why they are important to accelerate trust and help them stay on track. Edward Jones helps you positively impact clients' lives and work together to achieve their long-term financial goals, enabling you to make a difference in your community.
We'll give you the support you need. Our team will be there every step of the way, providing:
Paid training - Get registered and licensed and learn how to be a financial advisor with the industry's top training program¹.
Salary for the first five years as you begin to build your practice²
A firm-provided branch office in the community
Branch office support to help lighten the load so you can focus on your clients
A support network that extends from your branch office to your region to the home office - You'll work independently, but will have a team of thousands backing you every step of the way.
You can also expect...
No ceiling to your earning potential and growth, and your compensation is tied to the effort you put in
A compensation package that includes opportunities for commissions, profit sharing and incentive travel
The flexibility that you need to balance your personal and professional lives - the best of both worlds
A culture of continuous improvement and professional development
Key Responsibilities
Build relationships to create new clients via face-to-face and virtual sourcing strategies (residential, business, networking, introductions and referrals, social media, and speaking engagements).
Deeply understand clients' and prospective clients' needs, priorities, and concerns to accelerate trust and create personalized, comprehensive strategies to help them achieve their goals.
Oversee branch processes, roles, and responsibilities to ensure a high-quality, streamlined client experience consistent with firm policies and procedures, regulatory requirements, and ethical guidelines.
Engage the branch team to create, monitor, and adjust the branch business plan to increase branch effectiveness and achieve desired business results.
Create a highly engaging environment in the branch of mutual trust, respect, feedback and accountability.
¹ For the 25th consecutive year, Edward Jones was named a top company for training. The firm ranked No. 17 on Training magazine's prestigious 2025 Training APEX awards listed by Training magazine. 2025 Training Magazine Training Apex Award, published February 2025, date as of September 2024, an application fee was required for consideration
² As your new asset compensation and commissions increase over the first five years, salary will decrease
Benefits:
Edward Jones' compensation and benefits package includes medical and prescription drug, dental, vision, voluntary benefits (such as accident, hospital indemnity, and critical illness), disability income continuation, basic life, and basic AD&D coverage. Income continuation, basic life, and basic AD&D coverage are provided at no cost to financial advisors. Edward Jones offers a 401k retirement plan, and tax-advantaged accounts: health savings account and flexible spending account. Financial advisors enjoy flexibility in their schedule and, where required by applicable law, are eligible for paid sick leave and paid time off. Financial advisors may be eligible for bonuses; profit sharing; paid medical and parental leave for Financial Advisors that satisfy eligibility requirements; and participation in the firm's Travel Award Program. All associates are eligible for the firm's Employee Assistance Program. For more information on the Benefits available to financial advisors, please visit our benefits page.
Compensation:
We know that building a business takes time, so we've built a new financial advisor compensation program that supports and rewards you as you learn the skills, systems and business practices you need to succeed in our client-first business model. The new financial advisor compensation program includes trainee pay, a supplemental salary for up to five years, commissions and compensation for new assets gathered for the first five years.
For more information regarding compensation please click the link below.
New Financial Advisors Compensation
Supplemental Starting Salary Range $45,000 - $100,000
Read More About Job Overview
Skills/Requirements
Successful financial advisors demonstrate a unique combination of ambition, self-motivation, and commitment to establishing long-term client relationships. Financial advisors grow the business through identifying and creating new clients through initial discover of financial goals and deepening relationships with existing clients by reviewing investment strategies and implementation recommendations. Financial advisors earning potential is reflective of their performance.
What characteristics would make you a successful financial advisor?
An interest in financial services/markets and how they work
Love of learning and challenges, including determination to succeed
Skilled in long-term relationship building
Comfortable in your ability to think critically
Passion for new opportunities
Can you see yourself...
Learning to be a financial advisor through our comprehensive training program?
Delivering personalized investment and financial solutions to your clients?
Taking ownership of your business's growth and success?
Meeting professional and personal objectives as they relate to building your practice?
Working in and positively impacting your local community?
Skills/Requirements
Candidates should have at least one of the four qualifications bullets listed below:
A bachelor's degree is strongly preferred or equivalent work-related experience within the securities/financial services industry
Financial services and/or sales experience
Financial services registration, licensing, or certification
Professional and/or military career progression
Licensing:
SIE (which can be obtained without Firm sponsorship), Series 7 and Series 66 will be required; if not currently registered, registrations may be obtained at Edward Jones during the assigned paid study period.
FINRA registrations required within three months. State insurance licenses will be required.
As an associate, you are required to complete ongoing training offered by the firm and regulatory authorities (FINRA and SEC), as well as required CE training to ensure licenses remain in good standing.
Read More About Skills/Requirements
Awards & Accolades
At Edward Jones, we are building a place where everyone feels like they belong. We're proud of our associates' contributions to the firm and the recognitions we have received.
Check out our U.S. awards and accolades: Insights & Information Blog Postings about Edward Jones
Check out our Canadian awards and accolades: Insights & Information Blog Postings about Edward Jones
Read More About Awards & Accolades
About Us
Join a financial services firm where your contributions are valued. Edward Jones is a Fortune 500¹ company where people come first. With over 9 million clients and 20,000 financial advisors across the U.S. and Canada, we're proud to be privately-owned, placing the focus on our clients rather than shareholder returns.
Behind everything we do is our purpose: We partner for positive impact to improve the lives of our clients and colleagues, and together, better our communities and society. We are an innovative, flexible, and inclusive organization that attracts, develops, and inspires performance excellence and a sense of belonging.
People are at the center of our partnership. Edward Jones associates are seen, heard, respected, and supported. This is what we believe makes us the best place to start or build your career.
View our Purpose, Inclusion and Citizenship Report.
¹Fortune 500, published June 2024, data as of December 2023. Compensation provided for using, not obtaining, the rating.
Edward Jones does not discriminate on the basis of race, color, gender, religion, national origin, age, disability, sexual orientation, pregnancy, veteran status, genetic information or any other basis prohibited by applicable law.
#LI-USFATA
Advisor -Regulatory Compliance and Post Market
Lilly job in Durham, NC
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
**Position Brand Description:**
This position is responsible for providing GMP/GxP support across the different regulatory reporting and inspection support that is provided by the RCPMR (Regulatory Compliance and Post Market Reporting) team. This includes but is not limited to; all facets of inspections (PAI/PLI/Surveillance/Post-approval/for-cause) for all global Health Authorities. Support HA reporting (FAR, BPDR, OUS requirements). Provide support for global recall and US recall activities, monitoring and reporting of US product shortages, coordinate product shortage notification for OUS countries, update drug and device establishment registrations for changes as the need arises including completion of annual changes.
**Key Objectives/Deliverables:**
In this role the individual provides support that they provide to the different programs are as shown below. Primary focus is compliance support; other duties will depend on business needs.
**Compliance Support**
+ Lead inspection readiness activities
+ Serve as a global compliance CGMP expert providing feedback in preparation for corporate audits, agency inspections, global standard revisions, and changes in local business or manufacturing processes.
+ Proficient in application and use of Machine Learning and analytical tools to being continuously in a state of inspection ready.
**US (Field Alert Report-FAR, Biological Product Deviation Report-BPDR, EUA reporting, Illegitimate Product Report - Form 3911 per DSCSA) and Global regulatory reporting of Quality/safety/compliance issues**
+ Works with numerous stakeholders to ensure HA reporting as required to meet all Global regulations/requirements
**Global and US Recall / Market Withdrawal**
+ Supports the coordination of the execution activities related to US product recall and withdrawals.
+ Participate in periodic product withdrawal/recall simulations.
+ Consult and train local recall coordinators to assure understanding of process for product removal.
+ Monitors recall activities of partner organizations globally.
+ Provide information for use in various periodic reviews or metrics.
**Global and US Product Shortage**
+ Coordinate and execute product shortage reporting for US and OUS: Includes networking with Supply chain, Global Quality Leaders, Senior Management, Legal, Regulatory, Global Patient Safety, Qualified Persons at Affiliates and others as appropriate to determine the need and document the decision for FDA reporting or for notification to OUS regulatory agencies Generate, submit and maintain product shortage documentation following local procedure.
+ Provide information for use in various periodic reviews or metrics.
**Drug and Device Establishment Registration**
+ Determine information required for drug and device establishment registration for all manufacturers of US marketed product, such as importers, agent, and function.
+ Update drug and device establishment registrations for changes as required including completion of annual registrations.
**US Volume Reporting**
+ Coordinate and execute annual volume reporting for US
+ Provide information for use in various periodic reviews or metrics.
**Personal Development and Shared Learning**
+ Be continually aware of current industry trends and regulatory agency interpretation of GMP and other relevant requirements
+ Continue to gain knowledge vital to provide a greater understanding of GxP requirements
+ Participate in applicable external industry groups and forums
**Minimum Requirements:**
+ Bachelor's degree - Preferred degree in a scientific field such as Pharmacy, Chemistry, Engineering or other biological sciences.
+ Minimum of 5 years relevant Industry or Health Authority experience in areas which may include: technical services, manufacturing operations, quality assurance, quality control or regulatory affairs
**Additional Preferences:**
+ Broad knowledge of GMPs and quality systems for pharmaceutical manufacturing and marketing
+ Expertise in data driven approaches to assess site compliance
+ Experience in Quality Assurance or GxP function
+ Strong compliance knowledge
+ Excellent communication and presentation skills: ability to deliver constructive feedback
+ Skilled in interpreting and applying standards to diverse situations with strong problem-solving ability
+ Ability to work independently and collaboratively with minimal supervision
+ Significant experience supporting global inspections and compliance programs
**Other Information:**
+ Maintain awareness of regulatory and industry tends; ensure corporate standards remain current.
+ Flexibility to effectively prioritize work activities to meet regulated timelines.
+ Ability to influence and negotiate with peers, immediate supervision, site supervision and executive management.
+ Must be available to travel (domestic and international) when required (estimated at 25%, might increase based on business needs).
+ Role can be remote or based at any Lilly site/affiliate, corporate headquarters. Preference is at a Lilly site/affiliate or headquarters.
This is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements may change over time and may include additional responsibilities not specifically described in the job description.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$126,000 - $204,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
\#WeAreLilly
Process Technician - Filling (Night Shift)
Lilly job in Durham, NC
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
**Overview:**
The first of Lilly's new manufacturing plant network is in Durham, North Carolina. The site is dedicated to the production of incretin products. The manufacturing plant consists of formulation, filling, inspection, device assembly, and packaging operations.
**Responsibilities:**
Filling Technician is responsible for the safe and compliant daily execution of filling activities to produce pre-filled syringes. The Filling Technician is expected to model current Good Manufacturing Practices and to work with a team to ensure compliance with all safety and quality standards. This role will require flexibility to support multiple filling lines with a changing team dynamic. The roles will also support PFS9 isolator start up.
**Key Objectives**
+ Adhere to RTP Plant safety policies and procedures, contribute to a safe work environment.
+ Adhere to standard operating procedures and current Good Manufacturing Practices to ensure quality of product.
+ Support leadership on manufacturing floor by ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients.
+ Proactively monitor documentation and product quality, properly documenting all activities and reporting issues to supervision.
+ Execute documentation of process tasks adhering to ALCOA+ principles.
+ Execute material movement, cleaning, part install, line monitoring, navigate electronic systems to complete tasks, and any task designated by the supervisor.
+ Stand for extended hours and lift material overhead to support isolator activities.
+ Support PFS9 activities in commissioning and qualification and to commercial production.
**Basic Requirements:**
+ High School Diploma or equivalent
+ Ability to effectively communicate (written and verbal) and apply logic to problem solve unexpected events.
+ Ability to work 12-hour shifts on days (2-2-3 schedule) and work overtime as required and planned by the supervisor.
+ Ability to gown in a classified space, work in restrictive gowning/environment.
+ Ability to wear safety equipment (safety glasses, safety shoes, protective gloves etc.)
+ Basic computer skills for electronic batch record interface and training execution/documentation
+ BioWorks Certificate or equivalent experience
+ Knowledge of Current Good Manufacturing Practices (CGMPs)
**Additional Skills/Preferences:**
+ Scientific/technical degrees or certifications
+ Previous experience with pre-filled syringe (PFS) technology, utilizing solution filling equipment and/or isolator technology
+ Previous experience with Manufacturing Execution Systems and electronic batch release.
+ Knowledge of lean manufacturing principles
+ Ability to travel for training, potential travel is
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$17.30 - $34.38
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
\#WeAreLilly
Senior Scientist - TSMS
Lilly job in Durham, NC
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Organization Overview:
Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The API EM TS/MS Sr. Scientist will provide technical and scientific expertise within a dynamic external manufacturing environment. The Sr. Scientist is responsible for providing technical support to achieve the reliable and compliant manufacture of API drug substance at external contract manufacturing groups to predetermined global quality standards. This person interacts daily with a wide variety of people, primarily external partners team members and site management.
The candidate will be responsible for process monitoring, response to issues, and improvements where necessary. A strong understanding of manufacturing principles and Lilly systems is required to ensure those same standards are applied to the external contract manufacturers.
The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards. The position requires working cross-functionally within the site and other functions to deliver on technical objectives.
Key Objectives/Deliverables:
+ Provide technical oversight and stewardship for peptide manufacturing processes.
+ Leads resolution of technical issues including those related to control strategy and manufacturing.
+ Employ excellent communication skills to manage internal and external relationships.
+ Build and maintain relationships with development and central technical organizations.
+ Ensure proper characterization of processes and products and ensure effective documentation of the process description, measures, acceptable ranges, and specifications (and the justification of these measures, acceptable ranges, and specifications).
+ Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state.
+ Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose.
+ Influence and implement the network technical agenda and drive continuous improvement.
+ Maintaining peptide processes in a state of compliance with US and global regulations
+ Understanding the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
+ Operate with 'Team Lilly' in mind - including coaching and mentoring of peers and other scientists.
Basic Requirements:
+ Bachelors in scientific disciplines of Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Chemistry/Biochemistry strongly preferred)
+ 3+ years of demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.
Additional Preferences:
+ Knowledge and experience with Regulatory requirements
+ Knowledge of data management practices across manufacturing
+ Enthusiasm for changes, team spirit and flexibility
+ Ability to influence and communicate to diverse groups on business, or technical issues within the site and function
+ Proficiency in delivering complex tasks and/or tasks that are cross-functional
+ Demonstrated Project Management skills and ability to coordinate complex projects
Additional Information
+ Some travel (
+ Some off-shift work (night/weekend) may be required to support 24/7 operations
+ Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status).
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $171,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
\#WeAreLilly
Senior Director, Global Process Owner - Quality Risk Management
Lilly job in Durham, NC
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
**About** **the job**
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
**Responsibilities**
The Senior Director, Global Process Owner for Quality Risk Management, as a leader within the Global Quality Systems team, will establish and maintain the global quality system for Quality Risk Management. They will provide strategic oversight and expertise for the global QRM process, including Global Quality System standards, practices, business processes, implementation tools and associated IT systems. Additionally, the Global Process Owner will lead the QRM Community of Practice, including Global Process Leads and Area Process Owners. They will lead key global projects and priorities within the Quality System.
The Global Process Owner will consult with Lilly manufacturing facilities, external supplier organization, marketing affiliate quality operations, regulatory, research and development and other functions to educate on the quality system, and proactively ensure compliance of Lilly's Quality Systems with various country agency standards, industry trends and scientific principles.
**Key Objectives/Deliverables**
The Senior Director, Global Process Owner for Quality Risk Management is responsible to:
+ Establish and maintain the global quality system for QRMto drive standardization globally.
+ Own the Global Standards, Processes, Practices, Trainings, and implementation tools and ensure they are designed according to regulatory, industry and company expectations.
+ Provide governance, lead the implementations of improvement initiatives and foster a robust compliance mindset.
+ Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement.
+ Act as the leader and SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitatesaccurate reporting and analytics.
+ Define a common set of global effectiveness and efficiency metrics to drive end-to-end performance.
+ Monitor performance metrics, report and provide insights to inform decision making to drive further improvements.
+ Develop, lead, mentorand maintaina community of cross-functional SMEs to collaborate on proposed improvements and deepen the knowledge of the associated processes & tools.
+ Actively collaborate with enterprise-wide teams on standardized global business processes.
+ As the subject matter expert, ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations as needed.
+ Actively engage in external organizations and industry organizations to monitor policy changes for regulatory / external environments and advocate / influence quality related policies and regulatory requirements related to Quality Risk Management.
+ Own the global risk log and global risk register, ensuring that key quality risks across the enterprise are actively being mitigated.
+ Support the Quality Maturity Model initiatives by actively enhancing the cultural mindset across the enterprise to integrate QRM principles into routine processes.
**Basic Requirements:**
+ 10+ years' experiencein the pharmaceutical industry in GxP roles, with several years Quality experience.
+ Bachelor's degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field.
**Additional Skills/Preferences:**
+ Proven ability to work in a matrixed organization with diverse teams and influencing areas not under direct control.
+ Strong strategic thinking capability with a focus on the ability to execute strategic decisions while balancing conflicting priorities.
+ Proficiency in addressing operational challenges through structured approaches and innovative solutions.
+ Ability to drive process improvements and strategic decisions by analyzing and interpreting complex data.
+ Demonstrated change agility in anticipating and leading others through change and ambiguity.
+ Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate at all levels through various formats.
+ Expertise in developing scalable and standardized processes across global operations to improve efficiency and reduce complexity.
+ Demonstrated influential leadership expertise and experience engaging with senior-level functional leads.
+ Strong leadership capability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results.
+ Strong capabilities in establishing governance structures and proactively addressing quality and regulatory risks.
+ Demonstrated people management experience.
+ Expertise in navigating and ensuring adherence to global regulatory standards and frameworks.
+ Prior experience with common QRM tools, how and when to apply them, and maintenance of a risk log or risk register.
+ Prior experience working in at least two of Clinical Operations / Development, Pharmacovigilance, Product Research & Development or Commercial Manufacturing preferred.
**A** **dditional Information:**
+ Available to travel (domestic and international) when required.
+ Fluent in English, additional languages are also recommended.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $222,200
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
\#WeAreLilly
Filling Technician
Lilly job in Durham, NC
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
**Overview:**
The first of Lilly's new manufacturing plant network is in Durham, North Carolina. The site is dedicated to the production of incretin products. The manufacturing plant consists of formulation, filling, inspection, device assembly, and packaging operations.
**Responsibilities:**
Filling Technician is responsible for the safe and compliant daily execution of filling activities to produce pre-filled syringes. The Filling Technician is expected to model current Good Manufacturing Practices and to work with a team to ensure compliance with all safety and quality standards. This role will require flexibility to support multiple filling lines with a changing team dynamic. The roles will also support PFS9 isolator start up.
**Key Objectives**
+ Adhere to RTP Plant safety policies and procedures, contribute to a safe work environment.
+ Adhere to standard operating procedures and current Good Manufacturing Practices to ensure quality of product.
+ Support leadership on manufacturing floor by ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients.
+ Proactively monitor documentation and product quality, properly documenting all activities and reporting issues to supervision.
+ Execute documentation of process tasks adhering to ALCOA+ principles
+ Execute material movement, cleaning, part install, line monitoring, navigate electronic systems to complete tasks, and any task designated by the supervisor
+ Support PFS9 activities in commissioning and qualification and to commercial production.
**Basic Requirements:**
+ High School Diploma or equivalent
+ Ability to effectively communicate (written and verbal) and apply logic to problem solve unexpected events.
+ Ability to work 12-hour shifts on days (2-2-3 schedule) and work overtime as required and planned by the supervisor.
+ Ability to wear safety equipment (safety glasses, safety shoes, protective gloves etc.)
+ Basic computer skills for electronic batch record interface and training execution/documentation
+ BioWorks Certificate or equivalent experience
+ Knowledge of Current Good Manufacturing Practices (CGMPs)
**Additional Skills/Preferences:**
+ Scientific/technical degrees or certifications
+ Previous experience with pre-filled syringe (PFS) technology, utilizing solution filling equipment and/or isolator technology
+ Previous experience with Manufacturing Execution Systems and electronic batch release.
+ Knowledge of lean manufacturing principles
+ Ability to travel for training, potential travel is
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$17.30 - $38.08
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
\#WeAreLilly
Financial Advisor
Port Jervis, NY job
This job posting is anticipated to remain open for 30 days, from 02-Dec-2025. The posting may close early due to the volume of applicants. If you find yourself at a professional crossroads, a career as a financial advisor may be the right change for you. Financial advisors partner with clients to help them achieve their long-term financial goals: retirement, building wealth, estate strategies, funding education and more. As a financial advisor with Edward Jones, you'll develop and grow your own practice, supported by your branch team, a home-office team and other regional financial advisors. You'll benefit from the experience that comes from 100 years of history. We're proud to have more offices in the U.S. and Canada than any other investment firm, serving over eight million clients.
Our financial advisors are valued partners, and we credit much of our success to their unique experiences and professional backgrounds. We value an inclusive environment where everyone's different viewpoints help to achieve results. Financial advisors lead the branch team to serve clients and contribute to the firm's purpose. They deeply understand the client's goals and why they are important to accelerate trust and help them stay on track. Edward Jones helps you positively impact clients' lives and work together to achieve their long-term financial goals, enabling you to make a difference in your community.
We'll give you the support you need. Our team will be there every step of the way, providing:
Paid training - Get registered and licensed and learn how to be a financial advisor with the industry's top training program¹.
Salary for the first five years as you begin to build your practice²
A firm-provided branch office in the community
Branch office support to help lighten the load so you can focus on your clients
A support network that extends from your branch office to your region to the home office - You'll work independently, but will have a team of thousands backing you every step of the way.
You can also expect...
No ceiling to your earning potential and growth, and your compensation is tied to the effort you put in
A compensation package that includes opportunities for commissions, profit sharing and incentive travel
The flexibility that you need to balance your personal and professional lives - the best of both worlds
A culture of continuous improvement and professional development
Key Responsibilities
Build relationships to create new clients via face-to-face and virtual sourcing strategies (residential, business, networking, introductions and referrals, social media, and speaking engagements).
Deeply understand clients' and prospective clients' needs, priorities, and concerns to accelerate trust and create personalized, comprehensive strategies to help them achieve their goals.
Oversee branch processes, roles, and responsibilities to ensure a high-quality, streamlined client experience consistent with firm policies and procedures, regulatory requirements, and ethical guidelines.
Engage the branch team to create, monitor, and adjust the branch business plan to increase branch effectiveness and achieve desired business results.
Create a highly engaging environment in the branch of mutual trust, respect, feedback and accountability.
¹ For the 25th consecutive year, Edward Jones was named a top company for training. The firm ranked No. 17 on Training magazine's prestigious 2025 Training APEX awards listed by Training magazine. 2025 Training Magazine Training Apex Award, published February 2025, date as of September 2024, an application fee was required for consideration
² As your new asset compensation and commissions increase over the first five years, salary will decrease
Benefits:
Edward Jones' compensation and benefits package includes medical and prescription drug, dental, vision, voluntary benefits (such as accident, hospital indemnity, and critical illness), disability income continuation, basic life, and basic AD&D coverage. Income continuation, basic life, and basic AD&D coverage are provided at no cost to financial advisors. Edward Jones offers a 401k retirement plan, and tax-advantaged accounts: health savings account and flexible spending account. Financial advisors enjoy flexibility in their schedule and, where required by applicable law, are eligible for paid sick leave and paid time off. Financial advisors may be eligible for bonuses; profit sharing; paid medical and parental leave for Financial Advisors that satisfy eligibility requirements; and participation in the firm's Travel Award Program. All associates are eligible for the firm's Employee Assistance Program. For more information on the Benefits available to financial advisors, please visit our benefits page.
Compensation:
We know that building a business takes time, so we've built a new financial advisor compensation program that supports and rewards you as you learn the skills, systems and business practices you need to succeed in our client-first business model. The new financial advisor compensation program includes trainee pay, a supplemental salary for up to five years, commissions and compensation for new assets gathered for the first five years.
For more information regarding compensation please click the link below.
New Financial Advisors Compensation
Supplemental Starting Salary Range $45,000 - $100,000
Read More About Job Overview
Skills/Requirements
Successful financial advisors demonstrate a unique combination of ambition, self-motivation, and commitment to establishing long-term client relationships. Financial advisors grow the business through identifying and creating new clients through initial discover of financial goals and deepening relationships with existing clients by reviewing investment strategies and implementation recommendations. Financial advisors earning potential is reflective of their performance.
What characteristics would make you a successful financial advisor?
An interest in financial services/markets and how they work
Love of learning and challenges, including determination to succeed
Skilled in long-term relationship building
Comfortable in your ability to think critically
Passion for new opportunities
Can you see yourself...
Learning to be a financial advisor through our comprehensive training program?
Delivering personalized investment and financial solutions to your clients?
Taking ownership of your business's growth and success?
Meeting professional and personal objectives as they relate to building your practice?
Working in and positively impacting your local community?
Skills/Requirements
Candidates should have at least one of the four qualifications bullets listed below:
A bachelor's degree is strongly preferred or equivalent work-related experience within the securities/financial services industry
Financial services and/or sales experience
Financial services registration, licensing, or certification
Professional and/or military career progression
Licensing:
SIE (which can be obtained without Firm sponsorship), Series 7 and Series 66 will be required; if not currently registered, registrations may be obtained at Edward Jones during the assigned paid study period.
FINRA registrations required within three months. State insurance licenses will be required.
As an associate, you are required to complete ongoing training offered by the firm and regulatory authorities (FINRA and SEC), as well as required CE training to ensure licenses remain in good standing.
Read More About Skills/Requirements
Awards & Accolades
At Edward Jones, we are building a place where everyone feels like they belong. We're proud of our associates' contributions to the firm and the recognitions we have received.
Check out our U.S. awards and accolades: Insights & Information Blog Postings about Edward Jones
Check out our Canadian awards and accolades: Insights & Information Blog Postings about Edward Jones
Read More About Awards & Accolades
About Us
Join a financial services firm where your contributions are valued. Edward Jones is a Fortune 500¹ company where people come first. With over 9 million clients and 20,000 financial advisors across the U.S. and Canada, we're proud to be privately-owned, placing the focus on our clients rather than shareholder returns.
Behind everything we do is our purpose: We partner for positive impact to improve the lives of our clients and colleagues, and together, better our communities and society. We are an innovative, flexible, and inclusive organization that attracts, develops, and inspires performance excellence and a sense of belonging.
People are at the center of our partnership. Edward Jones associates are seen, heard, respected, and supported. This is what we believe makes us the best place to start or build your career.
View our Purpose, Inclusion and Citizenship Report.
¹Fortune 500, published June 2024, data as of December 2023. Compensation provided for using, not obtaining, the rating.
Edward Jones does not discriminate on the basis of race, color, gender, religion, national origin, age, disability, sexual orientation, pregnancy, veteran status, genetic information or any other basis prohibited by applicable law.
#LI-USFATA
Engineer- Process Safety
Lilly job in Durham, NC
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
+ **Main Purpose and Objectives of Position:** The Process Safety Engineer is part of the Lilly API Health, Safety, and Environmental (HSE) team and provides technical leadership and expertise in the development, implementation, and maintenance of process safety management and engineering support services to a Lilly API site, including the construction, startup, and operations phases.In the project delivery and startup phase of the project (startup expected 2025 to 2027), the HSE roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up. **Key Responsibilities for this role include:**
+ Support the development and implementation of the process safety management operational readiness plan for a Lilly API facility as a collaborative, inclusive, and energetic member of the HSE team.
+ Support the project team to deliver the facility as a key stakeholder providing input and feedback on process safety design decisions, construction, and startup plans while ensuring decisions meet project deliverables and compliance requirements, leveraging existing Lilly knowledge, and incorporating external experiences and learning.
+ Provide oversight and support of process hazard analysis and facility siting studies.
+ Develop and roll out process safety management (PSM) program elements such as employee participation, Management of Change, Pre-Startup Safety Review, Process hazard analysis (PHA), etc.
+ Provide training, mentoring, and onboarding of new staff to help support a strong process safety culture at the site.
+ Provide oversight of operations of pharmaceutical API manufacturing units.
+ Develop a partnership with Operations, Maintenance, and Engineering functions to help manage change, ensure safety and compliance of new systems, and assist in setting requirements to ensure safe startup.
+ Ensure application of industry codes and standards such as NPFA 30 (combustible liquids), NFPA 652 (combustible dust), and overpressure protection requirements during project and management of change reviews.
+ Build technical relationships by routinely interacting with corporate and site process safety colleagues. This role has opportunities to network externally with organizations such as the Center for Chemical Process Safety (CCPS), Purdue Process Safety and Assurance Center (P2SAC), and the ACC Process Safety networking groups. **Requirements:**
+ Bachelor's degree in chemical engineering, chemistry, or related field of study; CCPSC or PE preferred
+ Minimum 2 years of experience in chemical or pharmaceutical manufacturing **Additional Preferences:**
+ Knowledge and experience in process safety, including knowledge of OSHA Process Safety Management (PSM) regulation
+ Trained in Process Hazard Analysis, HAZOP, and What-If Methodologies
+ Strong analytical skills and systematic and structured way of working
+ Strong collaboration and communication skills
+ Trained in Process Hazard Analysis facilitation
+ Trained in Layer of Protection Analysis (LOPA)
+ Knowledge of EPA Risk Management Plan
+ Experience interfacing with HSE-related regulatory agencies **Additional Information:**
+ Please note that the role may begin remotely with occasional business travel to the Global Headquarters in Indianapolis, Indiana and to the new site area. Full relocation to the new site area will be required. Additional information will be provided during the interview process.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$63,000 - $92,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
\#WeAreLilly
Supervisor - QA Incoming
Lilly job in Durham, NC
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Lilly has a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina. The QA Supervisor -Incoming Inspection is responsible for providing leadership to the Quality - Incoming Inspection team. The QA Supervisor - Incoming will oversee the incoming materials, including goods receipt, sampling, incoming inspections/testing, and inbound/outbound shipping processes.
**Key Objectives/Deliverables:**
+ Practices safety behaviors with proper PPE and lifting techniques. Supports all HSE Corporate and Site Goals.
+ Manage the QA - Incoming team, consisting of 8-12 Quality Specialists.
+ Responsible for training and managing the QA - Incoming team in:
+ Performing incoming inspections (raw materials, components, printed packaging materials, etc.) according to priority.
+ Documenting inspections in accordance with procedures and specifications.
+ Ensuring materials not meeting specifications are quarantined, per local procedures.
+ Sampling, inspecting, and documenting results utilizing electronic systems (Darwin, SmartLab, etc).
+ When sampling a portion of the batch, ensure proper sampling plan is followed.
+ Working with the QC Lab to deliver samples and receive results
+ Performing ID testing of materials utilizing Raman or NIR Spectroscopy.
+ Maintaining retains and samples per local procedures.
+ Communicate with QA Disposition team to ensure materials are released in a timely manner, as to not delay production.
+ Evaluating damaged materials found on inbound shipments or within the warehouse and determine acceptability.
+ Ensuring storage condition is tracked, accurate, adjusted (as needed) including evaluating temperature excursions on shipments received at the warehouse.
+ Assists in resolving issues on inbound shipments (i.e.incorrect quantity or product, contamination, etc.).
+ Performs appropriate transactions in SAP to ensure system represents appropriate status of material (QI, blocked, scrapped, etc.)
+ Provides additional Quality support to warehouse, as necessary.
+ May need to assist with performing department activities to ensure materials are available for production.
+ Responsible for ensuring team is trained and training remains in compliance.
+ Communicates with Associate Director and Quality Representatives on quality issues.
+ Lead, mentor, and coach QA - Incoming team, Operations, and support personnel on quality matters, while supporting and driving the site Quality culture.
+ Ensure regular presence in operational areas to monitor GMP programs and quality systems.
+ Work with materials management group to initiate complaints/remarks to supplier for materials not meeting Lilly expectations.
+ May participate in investigations regarding materials or service complaints.
+ Networks with the business and ensures all materials are dispositioned in a timely manner to support production schedule.
+ Authors/revises SOPs, materials specifications, as needed.
+ Interacts with other quality functions including QA Warehouse
+ Supports material related Supplier Change Notification's (SCN).
+ Participates in/supports regulatory inspections, as needed.
**Requirements (Education, Experience, Training):**
+ High school diploma or GED
**Preferred attributes but not required:**
+ Previous materials or warehouse experience.
+ Previous experience leading and managing a team.
+ Demonstrated understanding of cGMP regulations related to QA Inspection applications.
+ Strong attention to detail.
+ Proficient in computer system applications.
+ Ability to organize and prioritize multiple tasks, highly flexible and able to work independently in fast paced environment to support production demands.
+ Excellent interpersonal and networking skills.
+ Highly motivated, enthusiastic, share ideas and lead solutions effectively to resolution; ensure safety of others.
+ Understanding of statistical tools and analysis.
+ Experience in inventory management systems (SAP, etc.)
+ Previous experience in GMP production environments.
+ Previous facility or area start up experience.
**Other Information:**
+ The position is for the Lilly Research Triangle Park site and will support a 24/7 operation
+ Ability to support off-shift requests
+ Ability to work 12 hour days - rotating 2-2-3 shifts.
+ Ability to work overtime as required.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$35.33 - $51.83
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
\#WeAreLilly
Director/Senior Director, Global Process Owner - Sterility Assurance QMS
Lilly job in Raleigh, NC
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
**Company Overview:**
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
**Organization Overview:**
Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network.
**Position Brand Description:**
The Director/Senior Director, Global Process Owner for Sterility Assurance, as a leader within the Technical Service, Manufacturing Sciences, Sterility Assurance team, will establish and maintain the global quality system procedural requirements for a Level 2 Process related to Aseptic Processing controls inclusive of Aseptic Process Simulations, Barrier System Management, Cleaning and Disinfection, Aseptic Technique, and Aseptic Training. They will provide strategic oversight and expertise for global Aseptic Processing Programs, including Quality Management System Sterility Assurance standards, practices, business processes, implementation tools and associated IT systems. Additionally, the Global Process Owner will lead an Aseptic Processing Program Community of Practice, including Global Process Leads and Area Process Owners. They will lead key global projects and priorities within the Sterility Assurance Level 1 Program.
The Global Process Owner will consult with Lilly manufacturing facilities, Global and Site Quality and other functions to educate on the Sterility Assurance program requirements, and proactively ensure compliance of the Lilly Sterility Assurance program with various country agency standards, industry trends and scientific principles.
**Key Objectives/Deliverables**
**The Director/Senior Director, Global Process Owner for Sterility Assurance Level 2 Processes is responsible to:**
+ Establish and maintain the global quality system for Aseptic Processing Programs to drive standardization globally.
+ Own the Global Standards, Processes, Practices, Trainings, and implementation tools and ensure they are designed according to regulatory, industry and company expectations.
+ Provide governance, lead the implementations of improvement initiatives and foster a robust compliance mindset.
+ Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement.
+ Act as the leader and SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitates accurate reporting and analytics.
+ Define a common set of global effectiveness and efficiency metrics to drive end-to-end performance.
+ Monitor performance metrics, report and provide insights to inform decision making to drive further improvements.
+ Develop, lead, mentor and maintain a community of cross-functional SMEs to collaborate on proposed improvements and deepen the knowledge of the associated processes & tools.
+ Actively collaborate with enterprise-wide teams on standardized global business processes.
+ As the subject matter expert, ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations as needed.
+ Actively engage in external organizations and industry organizations to monitor policy changes for regulatory / external environments and advocate / influence quality related policies and regulatory requirements related to Aseptic Processing requirements inclusive of Aseptic Process Simulations, Aseptic Technique and Barrier system (e.g. Isolators/RABs) management.
+ Provide overall guidance and leadership as related to Aseptic Process Simulation Program Design and Implementation, Aseptic Controls and Practices including Cleaning & Disinfection, Barrier System Controls, and Aseptic Technique
**Basic Requirements:**
+ 10+ years' experience in the pharmaceutical industry in roles across commercial manufacturing and or quality in a manufacturing, validation, and/or Quality roles supporting aseptic product manufacturing
+ 7+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment.
+ Bachelor's degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field.
+ Candidate will have previous experience implementing and leading global Sterility Assurance programs which can include Aseptic Training, Aseptic Process Simulations, and Isolator Controls and Management.
+ Strong technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, contamination control, Annex 1 interpretation)
+ Strong written and oral communication skills
+ Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance
+ Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals
+ Approximately 25% travel
**Additional Preferences:**
+ Proven ability to work in a matrixed organization leading diverse teams and influencing areas not under direct control.
+ Experience leading a major multi-site or global functions improvement initiative.
+ Strong strategic thinking capability with a focus on the ability to execute strategic decisions while balancing conflicting priorities.
+ Proficiency in addressing operational challenges through structured approaches and innovative solutions.
+ Ability to drive process improvements and strategic decisions by analyzing and interpreting complex data.
+ Demonstrated change agility in anticipating and leading others through change and ambiguity.
+ Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate at all levels through various formats.
+ Expertise in developing scalable and standardized processes across global operations to improve efficiency and reduce complexity.
+ Demonstrated influential leadership expertise and experience engaging with senior-level functional leads.
+ Strong leadership capability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results.
+ Strong capabilities in establishing governance structures and proactively addressing quality and regulatory risks.
+ Demonstrated people management experience.
+ Expertise in navigating and ensuring adherence to global regulatory standards and frameworks.
+ Experience leading a major multisite improvement initiative or driving multisite standardization.
+ Prior demonstrated experience managing aseptic processing programs including global procedural requirements and training.
+ Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed.
+ Support the establishment of a sterility assurance network or hub in global TSMS
+ Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance
**Education Requirements:**
BS/MS in a biological science (or equivalent work experience) or engineering discipline (Microbiology-preferred, Biology, Chemistry, Mechanical Engineering, Biomedical Engineering, etc.), preferably Microbiology.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $264,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
\#WeAreLilly
Lead Technician - Packaging (Day Shift)
Lilly job in Durham, NC
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
**Quick Benefits Overview:**
+ Medical, Dental, Vision, Prescription benefits are effective on your first day of employment
+ Paid vacation- starting annually at 120 hours (prorated based on start date)
The Operations Line Leader will be a key part of the Packaging team at RTP, where autoinjector devices are assembled. Line Leader will be responsible for the safe operation of highly automated equipment producing products of the highest quality serving Lilly patients worldwide. In addition, Line Leader will also be responsible for leadership, daily operations, development of operators, building technical autonomy, ensuring compliance with all policies, procedures, and ensuring resources are scheduled accordingly per the daily production plan.
**Key Objectives/Deliverables:**
+ Adhere to RTP Plant safety policies and procedures, contribute to a safe work environment.
+ Setup and operate highly automated equipment in the Device Assembly area.
+ Provide leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients.
+ Technical leader: Key resource for troubleshooting and functions as the primary point of contact for issue escalation on the shop floor.
+ Identify opportunities for operational improvements.
+ Proactively monitor documentation and product quality, properly documenting all activities and reporting issues to supervision.
+ Assist Supervisor in development and performance evaluations of shift operators.
+ Key liaison between operations and support functions.
+ Lead by example of Safety first & Quality always.
+ Operate the equipment and lead the shift operations as required to meet production schedule.
+ Assists in checking execution documentation (PMX, SAP, Cleaning Logs, etc.).
+ Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance.
+ Acts as back-up in Shift Supervisor absence.
**Basic Requirements:**
+ Previous experience in operations or directly supporting a pharmaceutical manufacturing operation.
+ Ability to work 12-hour days on rotating shift.
+ Ability to work overtime as required.
+ Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
**Additional Preferences:**
+ Previous Line Lead experience preferred.
+ Previous experience with highly automated equipment.
+ Previous experience with Manufacturing Execution Systems and electronic batch release.
+ Demonstrated leadership & persuasion skills.
+ Affinity for mastering technical concepts.
+ Solid understanding of FDA guidelines and CGMP standards.
+ Ability to effectively communicate (written and verbal).
+ Flexibility and problem-solving skills.
+ Basic computer skills (desktop software) are required.
**Other Information:**
+ This role will train on day shift initially.
+ The position is for the Lilly Research Triangle Park site.
+ Ability to wear safety equipment (safety glasses, safety shoes, protective gloves etc.)
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$25.96 - $38.08
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
\#WeAreLilly
Principal Process Engineer
Lilly job in Durham, NC
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
+ **Responsibilities** The Senior Principal Process Engineer provides technical leadership and expertise for production operations in the areas of: coaching and mentoring front line process engineers, developing and sustaining process knowledge, process and equipment support, process optimization, equipment qualification, equipment capability and asset management, and engineering business systems. This role will support production operation in small molecule or peptides manufacturing. Key Deliverables:
+ Coach and mentor front line process engineers in all aspects of fundamental engineering activities for batch API supply or continuous platforms.
+ Champion the application of statistical thinking and use of data to monitor process performance and make engineering decisions based on first principles.
+ Support and peer review root cause analysis for equipment and operational events and other technical documents.
+ Identify process knowledge gaps that impact equipment and process capability.
+ Develop or support the capture of key process knowledge (material and energy balances, kinetics, chemistry, equipment design basis, etc).
+ Support, develop and maintain the basis of safety for process equipment.
+ Provide engineering support for Process Safety Management (PSM) and Process Hazard Reviews (PHRs).
+ Review the basis for the qualification of the equipment and ensure that the equipment/system is appropriate for the intended purpose.
+ Ensure that changes, maintenance and other interventions do not adversely impact the qualification state of the equipment.
+ Integrate mechanistic modelling, process simulation and analysis into current and future processes to enhance process understanding and control.
+ Identify and implement continuous improvement opportunities related to equipment and processes as core member of cross-functional process team.
+ Lead/support the tech transfer of new processes and unit operations across batch and continuous processing platforms.
+ Provide technical oversight of ongoing equipment qualification requirements.
+ Provide technical oversight during development of equipment and process system User Requirements and related Design Review/Qualification documentation to ensure equipment and systems are appropriate for intended purpose.
+ Provide guidance in development of test plans for Verification packages and associated critical components.
+ Provide guidance on key elements of return to service requirements for equipment after interventions such as maintenance. **Basic Qualifications**
+ Bachelor's Degree in Process, Chemical, Biochemical Engineering or related applicable discipline
+ 5+ years of experience in API Manufacturing Unit Operations **Additional Skills/Preferences**
+ Deep technical interest and understanding in the field of Chemical Engineering.
+ Strong analytical and problem-solving skills.
+ Ability to work on own initiative and as part of a Process Team consisting of a diverse group of management, production, science and engineering professionals.
+ Ability to coach others for development of technical knowledge and skills.
+ Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented.
+ Guidance/mentoring of others through processes.
+ Flexibility to meet business needs. **Additional Information:**
+ Please note that the role may begin remotely with occasional business travel to the Global Headquarters in Indianapolis, Indiana and to the new site area. Full relocation to the area of new site will be required. Additional information will be provided during the interview process.
+ Potential for travel (less than 20% - could be domestic and/or international)
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$64,500 - $94,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
\#WeAreLilly
Process Technician - Manufacturing Support/Material Prep
Lilly job in Durham, NC
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Responsibilities:
+ The Operator/Technician will support commissioning/qualification activities required to bring material prep suites into service as well as supporting site operational activities. This position may require domestic travel with the potential of international travel based on program need.
+ This role will be responsible for execution of daily material prep operations tasks defined by the shift lead/supervisor.
+ Adhere to RTP Plant safety policies and procedures, contribute to a safe work environment.
+ Adhere to standard operating procedures and current Good Manufacturing Practices to ensure quality of product.
+ Document process steps on appropriate batch documentation (Electronic Ticket, SAP, Cleanings, etc.).
+ Attain and maintain qualification for the operation of assigned process equipment and duties in the area.
+ Identify opportunities for operational improvements.
+ Proactively monitor documentation and product quality, properly documenting all activities and reporting issues to supervision.
+ Contribute to the achievement of key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance.
+ Must be willing to work 12-hour shifts (2-2-3 schedule)
+ Candidate must be flexible and be willing to perform non-routine work with Safety & Integrity in mind at all times
+ Provide commissioning, qualification, and operational readiness support during project phase.
+ Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the Parenteral Formulation area.
+ Assists in checking execution documentation (PMX, SAP, Cleaning Logs, etc.)
+ Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance.
Basic Requirements:
+ High School Diploma or equivalent.
Additional Skills/Preferences:
+ Knowledge of current Good Manufacturing Practices (CGMPs).
+ Previous experience working in operations/pharmaceutical industry.
+ Previous experience compounding/formulation in a Grade C environment.
+ Previous experience using solution filling equipment and/or isolator technology.
+ Ability to effectively communicate (written and verbal).
+ Knowledge of lean manufacturing principles.
+ BioWork Certification.
Additional Information:
+ Ability to wear safety equipment required (safety glasses, safety shoes, protective gloves etc.).
+ Ability to gown and work in controlled classified areas (grade c and grade d).
+ Basic digital literacy (desktop software) is required.
+ Must pass a "fitness for duty" physical exam.
+ Ability to work 12-hour shifts on days (2-2-3 schedule) with additional overtime as the need arises.
+ Project phase will require a baseline 5-day work week with flexibility to adjust hours to support specific project tasks.
+ Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$17.30 - $38.08
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
\#WeAreLilly
Financial Advisor
Mount Pocono, PA job
This job posting is anticipated to remain open for 30 days, from 03-Dec-2025. The posting may close early due to the volume of applicants. If you find yourself at a professional crossroads, a career as a financial advisor may be the right change for you. Financial advisors partner with clients to help them achieve their long-term financial goals: retirement, building wealth, estate strategies, funding education and more. As a financial advisor with Edward Jones, you'll develop and grow your own practice, supported by your branch team, a home-office team and other regional financial advisors. You'll benefit from the experience that comes from 100 years of history. We're proud to have more offices in the U.S. and Canada than any other investment firm, serving over eight million clients.
Our financial advisors are valued partners, and we credit much of our success to their unique experiences and professional backgrounds. We value an inclusive environment where everyone's different viewpoints help to achieve results. Financial advisors lead the branch team to serve clients and contribute to the firm's purpose. They deeply understand the client's goals and why they are important to accelerate trust and help them stay on track. Edward Jones helps you positively impact clients' lives and work together to achieve their long-term financial goals, enabling you to make a difference in your community.
We'll give you the support you need. Our team will be there every step of the way, providing:
Paid training - Get registered and licensed and learn how to be a financial advisor with the industry's top training program¹.
Salary for the first five years as you begin to build your practice²
A firm-provided branch office in the community
Branch office support to help lighten the load so you can focus on your clients
A support network that extends from your branch office to your region to the home office - You'll work independently, but will have a team of thousands backing you every step of the way.
You can also expect...
No ceiling to your earning potential and growth, and your compensation is tied to the effort you put in
A compensation package that includes opportunities for commissions, profit sharing and incentive travel
The flexibility that you need to balance your personal and professional lives - the best of both worlds
A culture of continuous improvement and professional development
Key Responsibilities
Build relationships to create new clients via face-to-face and virtual sourcing strategies (residential, business, networking, introductions and referrals, social media, and speaking engagements).
Deeply understand clients' and prospective clients' needs, priorities, and concerns to accelerate trust and create personalized, comprehensive strategies to help them achieve their goals.
Oversee branch processes, roles, and responsibilities to ensure a high-quality, streamlined client experience consistent with firm policies and procedures, regulatory requirements, and ethical guidelines.
Engage the branch team to create, monitor, and adjust the branch business plan to increase branch effectiveness and achieve desired business results.
Create a highly engaging environment in the branch of mutual trust, respect, feedback and accountability.
¹ For the 25th consecutive year, Edward Jones was named a top company for training. The firm ranked No. 17 on Training magazine's prestigious 2025 Training APEX awards listed by Training magazine. 2025 Training Magazine Training Apex Award, published February 2025, date as of September 2024, an application fee was required for consideration
² As your new asset compensation and commissions increase over the first five years, salary will decrease
Benefits:
Edward Jones' compensation and benefits package includes medical and prescription drug, dental, vision, voluntary benefits (such as accident, hospital indemnity, and critical illness), disability income continuation, basic life, and basic AD&D coverage. Income continuation, basic life, and basic AD&D coverage are provided at no cost to financial advisors. Edward Jones offers a 401k retirement plan, and tax-advantaged accounts: health savings account and flexible spending account. Financial advisors enjoy flexibility in their schedule and, where required by applicable law, are eligible for paid sick leave and paid time off. Financial advisors may be eligible for bonuses; profit sharing; paid medical and parental leave for Financial Advisors that satisfy eligibility requirements; and participation in the firm's Travel Award Program. All associates are eligible for the firm's Employee Assistance Program. For more information on the Benefits available to financial advisors, please visit our benefits page.
Compensation:
We know that building a business takes time, so we've built a new financial advisor compensation program that supports and rewards you as you learn the skills, systems and business practices you need to succeed in our client-first business model. The new financial advisor compensation program includes trainee pay, a supplemental salary for up to five years, commissions and compensation for new assets gathered for the first five years.
For more information regarding compensation please click the link below.
New Financial Advisors Compensation
Supplemental Starting Salary Range $45,000 - $100,000
Read More About Job Overview
Skills/Requirements
Successful financial advisors demonstrate a unique combination of ambition, self-motivation, and commitment to establishing long-term client relationships. Financial advisors grow the business through identifying and creating new clients through initial discover of financial goals and deepening relationships with existing clients by reviewing investment strategies and implementation recommendations. Financial advisors earning potential is reflective of their performance.
What characteristics would make you a successful financial advisor?
An interest in financial services/markets and how they work
Love of learning and challenges, including determination to succeed
Skilled in long-term relationship building
Comfortable in your ability to think critically
Passion for new opportunities
Can you see yourself...
Learning to be a financial advisor through our comprehensive training program?
Delivering personalized investment and financial solutions to your clients?
Taking ownership of your business's growth and success?
Meeting professional and personal objectives as they relate to building your practice?
Working in and positively impacting your local community?
Skills/Requirements
Candidates should have at least one of the four qualifications bullets listed below:
A bachelor's degree is strongly preferred or equivalent work-related experience within the securities/financial services industry
Financial services and/or sales experience
Financial services registration, licensing, or certification
Professional and/or military career progression
Licensing:
SIE (which can be obtained without Firm sponsorship), Series 7 and Series 66 will be required; if not currently registered, registrations may be obtained at Edward Jones during the assigned paid study period.
FINRA registrations required within three months. State insurance licenses will be required.
As an associate, you are required to complete ongoing training offered by the firm and regulatory authorities (FINRA and SEC), as well as required CE training to ensure licenses remain in good standing.
Read More About Skills/Requirements
Awards & Accolades
At Edward Jones, we are building a place where everyone feels like they belong. We're proud of our associates' contributions to the firm and the recognitions we have received.
Check out our U.S. awards and accolades: Insights & Information Blog Postings about Edward Jones
Check out our Canadian awards and accolades: Insights & Information Blog Postings about Edward Jones
Read More About Awards & Accolades
About Us
Join a financial services firm where your contributions are valued. Edward Jones is a Fortune 500¹ company where people come first. With over 9 million clients and 20,000 financial advisors across the U.S. and Canada, we're proud to be privately-owned, placing the focus on our clients rather than shareholder returns.
Behind everything we do is our purpose: We partner for positive impact to improve the lives of our clients and colleagues, and together, better our communities and society. We are an innovative, flexible, and inclusive organization that attracts, develops, and inspires performance excellence and a sense of belonging.
People are at the center of our partnership. Edward Jones associates are seen, heard, respected, and supported. This is what we believe makes us the best place to start or build your career.
View our Purpose, Inclusion and Citizenship Report.
¹Fortune 500, published June 2024, data as of December 2023. Compensation provided for using, not obtaining, the rating.
Edward Jones does not discriminate on the basis of race, color, gender, religion, national origin, age, disability, sexual orientation, pregnancy, veteran status, genetic information or any other basis prohibited by applicable law.
#LI-USFATA
Director, Parenteral Sterility Assurance
Lilly job in Raleigh, NC
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network.
The purpose of this position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and enables building technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing.
**Responsibilities:**
+ Assess differences in current sterility assurance programs across the sites and drive harmonization
+ Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved.
+ Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved.
+ Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network.
+ Represent TS/MS on network Science Lead Team and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs.
+ Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking.
+ Building, maintaining, and growing capability across the organization in the sterility assurance space
+ Provide technical support to new sites/ filling lines during design and start-up activities to ensure sterility assurance programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability.
+ Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites.
+ Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly's position on technical/ regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice.
+ Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit for-purpose for robust and compliant commercial manufacturing.
+ Provide ad-hoc technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing.
+ Engage in providing support during regulatory interactions such as RtQ of submissions, and on-site inspections
+ Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals
**Basic Qualifications:**
+ BS Degree required.
+ MS/PhD in a biological science preferred.
+ 10+ years' experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred.
+ 10+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment preferred.
+ Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation)
+ Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities
+ Strong written and oral communication skills
+ Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology
+ Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance
+ Demonstrated experience influencing site and network leaders to advance technical agenda projects
**Additional Preferences:**
+ Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed.
+ Support the establishment of a sterility assurance network or hub in global TSMS
+ Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance
+ Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space
+ Work with engineering SME's to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance
+ Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options.
+ Strong capability to influence personnel and management across the organization
+ Close interaction with quality to enable internal audits that identify risks
+ Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance.
**Additional Information:**
+ Approximately 25% travel
_Lilly currently_ _anticipates_ _that the base salary for this position could range from between_ $133,500 _to_ $220,000 _and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend,_ _modify_ _, or_ _terminate_ _its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply_ _regarding_ _the details of any promotion or transfer of Lilly employees._
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$133,500 - $246,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
\#WeAreLilly
Financial Advisor
Lowell, IN job
This job posting is anticipated to remain open for 30 days, from 11-Dec-2025. The posting may close early due to the volume of applicants. If you find yourself at a professional crossroads, a career as a financial advisor may be the right change for you. Financial advisors partner with clients to help them achieve their long-term financial goals: retirement, building wealth, estate strategies, funding education and more. As a financial advisor with Edward Jones, you'll develop and grow your own practice, supported by your branch team, a home-office team and other regional financial advisors. You'll benefit from the experience that comes from 100 years of history. We're proud to have more offices in the U.S. and Canada than any other investment firm, serving over eight million clients.
Our financial advisors are valued partners, and we credit much of our success to their unique experiences and professional backgrounds. We value an inclusive environment where everyone's different viewpoints help to achieve results. Financial advisors lead the branch team to serve clients and contribute to the firm's purpose. They deeply understand the client's goals and why they are important to accelerate trust and help them stay on track. Edward Jones helps you positively impact clients' lives and work together to achieve their long-term financial goals, enabling you to make a difference in your community.
We'll give you the support you need. Our team will be there every step of the way, providing:
Paid training - Get registered and licensed and learn how to be a financial advisor with the industry's top training program¹.
Salary for the first five years as you begin to build your practice²
A firm-provided branch office in the community
Branch office support to help lighten the load so you can focus on your clients
A support network that extends from your branch office to your region to the home office - You'll work independently, but will have a team of thousands backing you every step of the way.
You can also expect...
No ceiling to your earning potential and growth, and your compensation is tied to the effort you put in
A compensation package that includes opportunities for commissions, profit sharing and incentive travel
The flexibility that you need to balance your personal and professional lives - the best of both worlds
A culture of continuous improvement and professional development
Key Responsibilities
Build relationships to create new clients via face-to-face and virtual sourcing strategies (residential, business, networking, introductions and referrals, social media, and speaking engagements).
Deeply understand clients' and prospective clients' needs, priorities, and concerns to accelerate trust and create personalized, comprehensive strategies to help them achieve their goals.
Oversee branch processes, roles, and responsibilities to ensure a high-quality, streamlined client experience consistent with firm policies and procedures, regulatory requirements, and ethical guidelines.
Engage the branch team to create, monitor, and adjust the branch business plan to increase branch effectiveness and achieve desired business results.
Create a highly engaging environment in the branch of mutual trust, respect, feedback and accountability.
¹ For the 25th consecutive year, Edward Jones was named a top company for training. The firm ranked No. 17 on Training magazine's prestigious 2025 Training APEX awards listed by Training magazine. 2025 Training Magazine Training Apex Award, published February 2025, date as of September 2024, an application fee was required for consideration
² As your new asset compensation and commissions increase over the first five years, salary will decrease
Benefits:
Edward Jones' compensation and benefits package includes medical and prescription drug, dental, vision, voluntary benefits (such as accident, hospital indemnity, and critical illness), disability income continuation, basic life, and basic AD&D coverage. Income continuation, basic life, and basic AD&D coverage are provided at no cost to financial advisors. Edward Jones offers a 401k retirement plan, and tax-advantaged accounts: health savings account and flexible spending account. Financial advisors enjoy flexibility in their schedule and, where required by applicable law, are eligible for paid sick leave and paid time off. Financial advisors may be eligible for bonuses; profit sharing; paid medical and parental leave for Financial Advisors that satisfy eligibility requirements; and participation in the firm's Travel Award Program. All associates are eligible for the firm's Employee Assistance Program. For more information on the Benefits available to financial advisors, please visit our benefits page.
Compensation:
We know that building a business takes time, so we've built a new financial advisor compensation program that supports and rewards you as you learn the skills, systems and business practices you need to succeed in our client-first business model. The new financial advisor compensation program includes trainee pay, a supplemental salary for up to five years, commissions and compensation for new assets gathered for the first five years.
For more information regarding compensation please click the link below.
New Financial Advisors Compensation
Supplemental Starting Salary Range $45,000 - $100,000
Read More About Job Overview
Skills/Requirements
Successful financial advisors demonstrate a unique combination of ambition, self-motivation, and commitment to establishing long-term client relationships. Financial advisors grow the business through identifying and creating new clients through initial discover of financial goals and deepening relationships with existing clients by reviewing investment strategies and implementation recommendations. Financial advisors earning potential is reflective of their performance.
What characteristics would make you a successful financial advisor?
An interest in financial services/markets and how they work
Love of learning and challenges, including determination to succeed
Skilled in long-term relationship building
Comfortable in your ability to think critically
Passion for new opportunities
Can you see yourself...
Learning to be a financial advisor through our comprehensive training program?
Delivering personalized investment and financial solutions to your clients?
Taking ownership of your business's growth and success?
Meeting professional and personal objectives as they relate to building your practice?
Working in and positively impacting your local community?
Skills/Requirements
Candidates should have at least one of the four qualifications bullets listed below:
A bachelor's degree is strongly preferred or equivalent work-related experience within the securities/financial services industry
Financial services and/or sales experience
Financial services registration, licensing, or certification
Professional and/or military career progression
Licensing:
SIE (which can be obtained without Firm sponsorship), Series 7 and Series 66 will be required; if not currently registered, registrations may be obtained at Edward Jones during the assigned paid study period.
FINRA registrations required within three months. State insurance licenses will be required.
As an associate, you are required to complete ongoing training offered by the firm and regulatory authorities (FINRA and SEC), as well as required CE training to ensure licenses remain in good standing.
Read More About Skills/Requirements
Awards & Accolades
At Edward Jones, we are building a place where everyone feels like they belong. We're proud of our associates' contributions to the firm and the recognitions we have received.
Check out our U.S. awards and accolades: Insights & Information Blog Postings about Edward Jones
Check out our Canadian awards and accolades: Insights & Information Blog Postings about Edward Jones
Read More About Awards & Accolades
About Us
Join a financial services firm where your contributions are valued. Edward Jones is a Fortune 500¹ company where people come first. With over 9 million clients and 20,000 financial advisors across the U.S. and Canada, we're proud to be privately-owned, placing the focus on our clients rather than shareholder returns.
Behind everything we do is our purpose: We partner for positive impact to improve the lives of our clients and colleagues, and together, better our communities and society. We are an innovative, flexible, and inclusive organization that attracts, develops, and inspires performance excellence and a sense of belonging.
People are at the center of our partnership. Edward Jones associates are seen, heard, respected, and supported. This is what we believe makes us the best place to start or build your career.
View our Purpose, Inclusion and Citizenship Report.
¹Fortune 500, published June 2024, data as of December 2023. Compensation provided for using, not obtaining, the rating.
Edward Jones does not discriminate on the basis of race, color, gender, religion, national origin, age, disability, sexual orientation, pregnancy, veteran status, genetic information or any other basis prohibited by applicable law.
#LI-USFATA
Financial Advisor
Santa Maria, CA job
This job posting is anticipated to remain open for 30 days, from 20-Nov-2025. The posting may close early due to the volume of applicants. If you find yourself at a professional crossroads, a career as a financial advisor may be the right change for you. Financial advisors partner with clients to help them achieve their long-term financial goals: retirement, building wealth, estate strategies, funding education and more. As a financial advisor with Edward Jones, you'll develop and grow your own practice, supported by your branch team, a home-office team and other regional financial advisors. You'll benefit from the experience that comes from 100 years of history. We're proud to have more offices in the U.S. and Canada than any other investment firm, serving over eight million clients.
Our financial advisors are valued partners, and we credit much of our success to their unique experiences and professional backgrounds. We value an inclusive environment where everyone's different viewpoints help to achieve results. Financial advisors lead the branch team to serve clients and contribute to the firm's purpose. They deeply understand the client's goals and why they are important to accelerate trust and help them stay on track. Edward Jones helps you positively impact clients' lives and work together to achieve their long-term financial goals, enabling you to make a difference in your community.
We'll give you the support you need. Our team will be there every step of the way, providing:
Paid training - Get registered and licensed and learn how to be a financial advisor with the industry's top training program¹.
Salary for the first five years as you begin to build your practice²
A firm-provided branch office in the community
Branch office support to help lighten the load so you can focus on your clients
A support network that extends from your branch office to your region to the home office - You'll work independently, but will have a team of thousands backing you every step of the way.
You can also expect...
No ceiling to your earning potential and growth, and your compensation is tied to the effort you put in
A compensation package that includes opportunities for commissions, profit sharing and incentive travel
The flexibility that you need to balance your personal and professional lives - the best of both worlds
A culture of continuous improvement and professional development
Key Responsibilities
Build relationships to create new clients via face-to-face and virtual sourcing strategies (residential, business, networking, introductions and referrals, social media, and speaking engagements).
Deeply understand clients' and prospective clients' needs, priorities, and concerns to accelerate trust and create personalized, comprehensive strategies to help them achieve their goals.
Oversee branch processes, roles, and responsibilities to ensure a high-quality, streamlined client experience consistent with firm policies and procedures, regulatory requirements, and ethical guidelines.
Engage the branch team to create, monitor, and adjust the branch business plan to increase branch effectiveness and achieve desired business results.
Create a highly engaging environment in the branch of mutual trust, respect, feedback and accountability.
¹ For the 25th consecutive year, Edward Jones was named a top company for training. The firm ranked No. 17 on Training magazine's prestigious 2025 Training APEX awards listed by Training magazine. 2025 Training Magazine Training Apex Award, published February 2025, date as of September 2024, an application fee was required for consideration
² As your new asset compensation and commissions increase over the first five years, salary will decrease
Benefits:
Edward Jones' compensation and benefits package includes medical and prescription drug, dental, vision, voluntary benefits (such as accident, hospital indemnity, and critical illness), disability income continuation, basic life, and basic AD&D coverage. Income continuation, basic life, and basic AD&D coverage are provided at no cost to financial advisors. Edward Jones offers a 401k retirement plan, and tax-advantaged accounts: health savings account and flexible spending account. Financial advisors enjoy flexibility in their schedule and, where required by applicable law, are eligible for paid sick leave and paid time off. Financial advisors may be eligible for bonuses; profit sharing; paid medical and parental leave for Financial Advisors that satisfy eligibility requirements; and participation in the firm's Travel Award Program. All associates are eligible for the firm's Employee Assistance Program. For more information on the Benefits available to financial advisors, please visit our benefits page.
Compensation:
We know that building a business takes time, so we've built a new financial advisor compensation program that supports and rewards you as you learn the skills, systems and business practices you need to succeed in our client-first business model. The new financial advisor compensation program includes trainee pay, a supplemental salary for up to five years, commissions and compensation for new assets gathered for the first five years.
For more information regarding compensation please click the link below.
New Financial Advisors Compensation
Supplemental Starting Salary Range $45,000 - $100,000
Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance and the California Fair Chance Act. Edward Jones is prohibited from hiring individuals with certain specified criminal history as set forth in Section 3(a)(39) and 15(b)(4) and Rule 17a-3(a)(12) of the Securities and Exchange Act of 1934, and conducts background reviews consistent with FINRA Rule 3110(e). A copy of a notice regarding the provisions of the Los Angeles County Fair Chance Ordinance is available at: dcba.lacounty.gov/wp-content/uploads/2024/08/FCOE-Official-Notice-Eng-Final-8.30.2024.pdf.
Read More About Job Overview
Skills/Requirements
Successful financial advisors demonstrate a unique combination of ambition, self-motivation, and commitment to establishing long-term client relationships. Financial advisors grow the business through identifying and creating new clients through initial discover of financial goals and deepening relationships with existing clients by reviewing investment strategies and implementation recommendations. Financial advisors earning potential is reflective of their performance.
What characteristics would make you a successful financial advisor?
An interest in financial services/markets and how they work
Love of learning and challenges, including determination to succeed
Skilled in long-term relationship building
Comfortable in your ability to think critically
Passion for new opportunities
Can you see yourself...
Learning to be a financial advisor through our comprehensive training program?
Delivering personalized investment and financial solutions to your clients?
Taking ownership of your business's growth and success?
Meeting professional and personal objectives as they relate to building your practice?
Working in and positively impacting your local community?
Skills/Requirements
Candidates should have at least one of the four qualifications bullets listed below:
A bachelor's degree is strongly preferred or equivalent work-related experience within the securities/financial services industry
Financial services and/or sales experience
Financial services registration, licensing, or certification
Professional and/or military career progression
Licensing:
SIE (which can be obtained without Firm sponsorship), Series 7 and Series 66 will be required; if not currently registered, registrations may be obtained at Edward Jones during the assigned paid study period.
FINRA registrations required within three months. State insurance licenses will be required.
As an associate, you are required to complete ongoing training offered by the firm and regulatory authorities (FINRA and SEC), as well as required CE training to ensure licenses remain in good standing.
Read More About Skills/Requirements
Awards & Accolades
At Edward Jones, we are building a place where everyone feels like they belong. We're proud of our associates' contributions to the firm and the recognitions we have received.
Check out our U.S. awards and accolades: Insights & Information Blog Postings about Edward Jones
Check out our Canadian awards and accolades: Insights & Information Blog Postings about Edward Jones
Read More About Awards & Accolades
About Us
Join a financial services firm where your contributions are valued. Edward Jones is a Fortune 500¹ company where people come first. With over 9 million clients and 20,000 financial advisors across the U.S. and Canada, we're proud to be privately-owned, placing the focus on our clients rather than shareholder returns.
Behind everything we do is our purpose: We partner for positive impact to improve the lives of our clients and colleagues, and together, better our communities and society. We are an innovative, flexible, and inclusive organization that attracts, develops, and inspires performance excellence and a sense of belonging.
People are at the center of our partnership. Edward Jones associates are seen, heard, respected, and supported. This is what we believe makes us the best place to start or build your career.
View our Purpose, Inclusion and Citizenship Report.
¹Fortune 500, published June 2024, data as of December 2023. Compensation provided for using, not obtaining, the rating.
Edward Jones does not discriminate on the basis of race, color, gender, religion, national origin, age, disability, sexual orientation, pregnancy, veteran status, genetic information or any other basis prohibited by applicable law.
#LI-USFATA