Leadless Clinical Specialist - Charlotte, NC/ Raleigh, NC/Columbia, SC/Richmond, VA
Abbott Laboratories job in Charlotte, NC
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:
Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with a high employer contribution ·
Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position is a field-based position, and you can be based in Charlotte, NC/ Raleigh, NC/Columbia, SC/Richmond, VA in the Cardiac Rhythm Management Leadless division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias or irregular heartbeats.
What You'll Work On
The Regional Leadless Specialist provides technical, clinical, educational and sales support to ensure adoption and growth of Abbott leadless technology. The Regional Leadless Specialist works closely with the internal and external customers to drive therapy adoption and procedural success.
Job Duties:
Educates physicians, nurses, educators, and other health care providers on the indications and selection of patients for leadless pacing.
Provide procedural support in accordance with the instructions for use/trial protocol, and best-practices to facilitate procedural consistency and best clinical outcomes.
Assist in education and training activities for Abbott personnel.
Stay abreast of and communicates clinical data regarding leadless CRM products.
Coordinate/deliver/implement programs and resources to facilitate market expansion and therapy access.
Provide market intelligence for fine-tuning of therapy training and expansion plans.
Liaison with marketing for technology improvements and next generation product feedback.
Complete administrative reporting as assigned.
Exercise judgment in planning and organizing work; monitors performance and reports status.
Uses best business practices to ensure success and cost effectiveness in areas of responsibility.
Ensures employee compliance with Abbott policies and practices.
Qualifications:
Required:
Bachelor's degree in a relevant technical field, engineering) or equivalent/related experience.
7+ yrs of clinical medical device experience or equivalent, ideally with CRM products.
A comprehensive ability to analyze and evaluate technologically complex devices
Ability to collaborate and work with others effectively.
High-level of comfort in navigating the medical environment, to include labs and hospital settings.
Proven success displaying confidence in leading & influencing customers; ability to confidently provide guidance to course correct as needed.
Ability to prepare and present effectively written and verbal communications.
Thorough familiarity with medical device industry policies, operations and procedures.
Expert verbal and written communication, interpersonal and presentation skills.
Demonstrated working knowledge of frequently used personal computer programs and applications, such as, Microsoft Office.
This role will engage in considerable travel and will spend a significant amount of time "on the road" (approximately 50-75% of time).
Preferred:
Previous cardiac leadless device training/education certification or designation.
Previous sales experience and/or demonstrated business acumen.
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: **********************
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an
Equal Opportunity Employer, committed to employee diversity.
Connect with us at *************** on Facebook at *********************** and on Twitter @AbbottNews.
The base pay for this position is
$85,300.00 - $170,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Support ServicesDIVISION:CRM Cardiac Rhythm ManagementLOCATION:United States of America : RemoteADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 50 % of the TimeMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************
Auto-ApplyDistribution Field Manager - Coastal Region
Abbott Laboratories job in Charlotte, NC
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:
* Career development with an international company where you can grow the career you dream of.
* Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
* An excellent retirement savings plan with a high employer contribution
* Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
* A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.
The Opportunity
The Distribution Field Manager (DFM) is responsible for strategic customer relationships primarily focused on our non-acute Distribution partnerships. The DFM establishes and builds senior-level relationships and leverages them in driving new profitable sales and expanding utilization in current accounts. Understands and assesses customer's business issues and objectives and presents innovative ID solutions. Responsible for leading an internal team without direct authority and overall management of our Regional partners.
This is a remote sales opportunity and will cover the Coastal Region (SC, NC, E. TN, S. VA and S. W. VA) estimated 70% travel. Incumbent to live in a major metro area (ideally based in Charlotte or Raleigh, NC)
What You'll Work On
* Distributor Relationship Management:
* Establish and maintain strong relationships with distributors within the assigned region.
* Collaborate closely with distributors to understand their needs, challenges, and growth opportunities.
* Ensure timely communication and resolution of any issues or concerns
* Product Growth:
* Manage sales activities with distributors to promote our key products.
* Determine opportunities for expanding product reach and market share.
* Design strategies to drive growth, based on sales data.
* Ability to get unfair mindshare and focus within a distribution channel that has hundreds of partners.
* Drive field collaboration and focus with Abbott field sales and management and distribution partners sales and management teams at a regional level.
* Evaluate and direct the value of selling through distribution to Abbott sales reps and managers.
* Coordinate with Sales and Marketing to help win larger deals that involve
* distribution and include their key stakeholders.
* Performance:
* Establish and track key performance indicators (KPIs) related to distribution
* excellence.
* Regularly evaluate distributor performance and address any deviations from
* targets.
* Manage performance for their respective regions to achieve annual sales goals.
* Coordinate routine business reviews that may include the C-suite from Abbott and the distribution partner C-suite.
* Design and conduct business reviews with Regional and Area leaders to review distributor performance, obstacles to achieving success and competitive information
Required Qualifications
* Bachelor's degree
* 7+ years of relevant sales experience in the Point of Care, Diagnostics or Healthcare Capital Equipment industry, of which 4 or more years should be working with distribution partners
* Must be willing to travel 70%
* Overnight travel required.
* Candidates should possess the following: Background of success in value-based solution- selling, ability to form and develop long-term strategic interpersonal, professional senior level relationships; influence without direct authority; Executive level business and financial acumen with strong negotiation skills.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: **********************
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at *************** on Facebook at ************************ and on Twitter @AbbottNews.
The base pay for this position is $85,300.00 - $170,700.00. In specific locations, the pay range may vary from the range posted.
Auto-ApplySr Specialty Representative- Cardiovascular- Winston Salem , NC
Charlotte, NC job
Career CategorySalesJob Description
Territory covers:
Winston Salem
HOW MIGHT YOU DEFY IMAGINATION?
You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Sr. Specialty Representative
Live
What you will do
Let's do this. Let's change the world. In this vital role you will be the liaison to our customers by providing clinical knowledge of our products to medical professionals.
Amgen's medicines treat serious illnesses and our research address diseases with a limited number of treatment options. With a robust and differentiated pipeline, Amgen remains committed to advancing science to dramatically improve people's lives. As a values-based organization with a powerful sense of shared purpose toward our mission: to serve patients, we are actively searching for a Senior Specialty Representative to deliver on this commitment to patients.
Amgen supports and encourages our team members to have long term, fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities such as this opportunity to craft a long-term career with Amgen. The Senior Specialty Representative acts as the primary customer contact and is responsible for executing marketing strategy and promoting Amgen products as led by the District Manager.
Our Senior Specialty Representatives achieve territory sales by utilizing their background and experience to:
Provide current and comprehensive clinical knowledge of Amgen's products and effectively communicate the clinical and economic benefits of the products to medical professionals
Perform as a sales leader to achieve territory sales by executing and delivering branded sales messages strategies. This includes: delivering branded sales messages, executing planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets
Utilize internal and external relationships to service and manage accounts which includes: ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts
Analyze business effectiveness of sales activities and territory analysis, as well as develop territory plans with the District Manager
Have passion for our products and sustain that passion through the entire sales cycle while always building our brand, never losing sight of how we serve patients
Partner with other colleagues to share best practices and be in a state of continuous curiosity and learning to help grow as a Senior Specialty Representative
Leverage passion for disease state awareness, industry, regulatory and competitive changes to deliver agreed results
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The sales professional we seek is a motivated individual with these qualifications.
Basic Qualifications:
Bachelor's degree and 3 years of sales experience and/or clinical experience in healthcare / scientific field that is not sales related
OR
Associate degree and 6 years of sales experience and/or clinical experience in healthcare / scientific field that is not sales related
OR
High school diploma / GED and 8 years of sales experience and/or clinical experience in healthcare / scientific field that is not sales related
Preferred Qualifications:
· More than 3 years' Sales, marketing and/or clinical experience within pharmaceutical, biotech, diagnostics, healthcare insurance, pharmacy services, healthcare medical device or medical supply industries
· Product or hospital sales experience in the areas of oncology, cardiology, inflammation, nephrology, dermatology, rheumatology, neurology, endocrinology, hepatology, gastroenterology, bone health, respiratory, hematology, or infectious diseases; and the diseases and treatments involved with these specialties
· Advanced influencing and relationship-building skills with a focus on sales outcomes
· Local Market knowledge
· Bachelor's degree in Life Sciences or Business Administration
· Adaptability with our Core Competencies: Sales Planning and Organizing; Leveraging Business, Industry, and Technical Knowledge; Communicating with Impact; Driving for Results; and Cultivating Internal and External Relationships.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $118,796 - $141,175. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Apply now
For a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
Application deadline
External/Internal postings:
Amgen's application deadline is 11/30/2025 for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.
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Salary Range
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Auto-ApplyMedical Value and Access Liaison - Southeast US
Charlotte, NC job
Career CategoryMedical AffairsJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Medical Value Access Liaison - Southeast USTerritory Coverage: Southeast Coverage to include KY, VA, TN, NC, SC, GA, AL, FL, PRWhat you will do
Let's do this. Let's change the world. In this vital role you will develop programs, activities and relationships, both externally and internally to Amgen, in order to advance the value and clinical knowledge of our products to the payer community.
This is a field-based position within the Medical Value & Population Health team, within the Regional Medical Value Access Liaisons (MVAL) group in Scientific Affairs, reporting to a Director.
Geographic region for this position is within the U.S. business and majority regional accounts and select payer integrated IDNs as assigned.
Responsibilities:
Provide Payer and Formulary Support through value and medical presentations that focus on therapeutic as well as economic outcomes and utilization aspects of products, and in clinical policy discussions such as evidence-based medicine, clinical guidelines and prior authorization in areas where Amgen has therapeutic expertise.
Identify, develop, and maintain collaborative relationships with current and future Payer, Policy, IDN, and Health Economic and Outcomes Research opinion leaders through identifying speaker opportunities and concepts and letters of intent for investigator supported economics, humanistic outcome, and non-registration clinical studies to support Amgen's product messages within scope.
Interact with key internal stakeholders to provide feedback on customer trends in interpreting and using value evidence, reimbursement and payer policy.
Provide complex value-based technical information inclusive of medical education, health outcomes and Pharmacoeconomics information and models and research protocol opportunities to appropriate audiences.
Represent Amgen Scientific Affairs to designated payer & select IDN accounts.
Represent Amgen to designated thought leaders in health economics and outcomes research for Amgen Global Health Economics (GHE) and Amgen Center for Observational Research (CfOR).
Foster scientific information exchange as it relates to reimbursement and coverage policy between the medical community and Amgen.
Collect and report competitive intelligence within Amgen's competitive intelligence guidelines.
Effectively manage internal relationships, budgets, and T and E within guidelines.
Conduct all assigned duties within Amgen compliance guidelines.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a Medical Value Access Liaison with these qualifications.
Basic Qualifications:
Doctorate degree & 2 years of Medical Affairs experience
OR
Master's degree & 6 years of Medical Affairs experience
OR
Bachelor's degree & 8 years of Medical Affairs experience
Preferred Qualifications:
Pharm.D., Ph.D., M.D. or D.O.
Five years Biotech industry experience working directly with US Payer Accounts
CV, Metabolic, Inflammation, Bone, Neuro Oncology therapeutic area expertise
Deep knowledge of managed markets, US Reimbursement Landscape, Pharmacoeconomics, Population Health, and other broad healthcare trends.
Experience in Patient Access in US and / or global markets
Project management experience within a biopharmaceutical company
Strong advocacy, communication and team cohesion skills
Critical thinking, analytical and project management skills
Ability to lead and manage projects from concept to completion
Strong interpersonal skills, negotiation skills, active listening, and relationship management skills
Interface effectively with all levels, including senior management
Ability to influence others while fostering a value-based environment of dedication and fairness
Ability to understand, plan, and navigate in a matrix and, at times, ambiguous environment
Strong verbal and written communication skills; ability to clearly and effectively present information
Demonstrates creativity and foresight in anticipating and solving complex project issues
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
174,186.00 USD - 201,183.00 USD
Auto-ApplyOperator, Packaging (Night Shift)
Concord, NC 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.
Organization Overview:
For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.
Responsibilities:
During the project phase, Operators (Entry to Lead roles) will support start up activities required to bring the area into service. They will become the experts within their assigned area and educate their team in the proper operation of the facility. The Expert and Lead roles are expected to become the leaders for the equipment and process and will lead the training of new staff. After the project phase is complete, this role will be responsible for ensuring continuous supply of our medicines by, running the process, troubleshooting, and collaborating cross-functionally, and holding all to our safety first / quality always mindset. Expert and Lead Operators will coordinate daily activities to meet capacity plans while developing their own and our team's capabilities.
Key Objectives/Deliverables:
Provide leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients.
Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals.
Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques.
Technical leader: Key resource for troubleshooting and functions as the primary point of contact for issue escalation on the shop floor.
Responsible for administering technical training and ensuring all operators are trained to perform tasks.
Operate the equipment and perform activities as required to meet production schedule.
Assists in checking execution documentation (Electronic Batch Record, SAP, Cleaning Logs)
Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance.
Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls
(Lead role) Assist Supervisor in development and performance evaluations of shift operators. Act as backup for Supervisor.
Key liaison between operations and support functions.
Basic Requirements:
High School Diploma or GED
Ability to effectively communicate (electronically, written and verbal)
Flexibility - the ability to troubleshoot and triage challenges
Computer proficiency (desktop software, MS office).
Must pass a vision exam and be free of color blindness
Must be equivalent to 20/20 correctable close vision acuity
Additional Skills/Preferences:
(Senior and Lead roles) Leadership and the ability to train / educate team members
Knowledge of current Good Manufacturing Practices (CGMPs)
Previous experience working in operations/pharmaceutical industry
Previous experience with Manufacturing Execution Systems and electronic batch release.
Knowledge of lean manufacturing principles
Additional Information:
Ability to wear safety equipment (glasses, shoes, gloves, etc)
Ability to work 12-hour shifts on nights (2-2-3 schedule)
This is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the . For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the 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.
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.
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.
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
Auto-ApplyOperator, Formulation (Night Shift)
Concord, NC 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.
Job Description
Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company's capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site.
If you ever wanted to have a direct impact building a team's culture and in how the team operates, now is the perfect opportunity!
During the project phase, the Parenteral (PAR) Operators (Entry to Expert roles) will support start up activities required to bring the area into service which may include formulation, aseptic isolator barrier filling, and visual inspection. They will become the experts within their assigned area and educate their team in the proper operation of the facility.
After project phase is complete, this role will be responsible for ensuring continuous supply of our medicines by; expertly running the process, troubleshooting, and collaborating cross-functionally, and holding all to our safety first / quality always mindset. Operators will support daily activities to meet capacity plans while developing their own and our team's capabilities.
Job Responsibility
As a site leader and expert at our growing site, you'll have significant opportunities for growth into future leadership and technical roles.
Integrity
Provide leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients.
Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals.
Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques.
Excellence
Technical leader: Key resource for troubleshooting and functions as the primary point of contact for issue escalation on the shop floor.
Responsible for administering technical training and ensuring all operators are trained to perform tasks.
Operate the equipment and perform activities as required to meet production schedule.
Assists in checking execution documentation (Electronic Batch Record, SAP, Cleaning Logs)
Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance.
Respect for People
Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the PAR areas.
Key liaison between operations and support functions.
Basic Qualifications/Requirements
We have several levels open for Operator which are based on the experience and education you bring.
Minimum education: High School Diploma or GED
Ability to effectively communicate (electronically, written and verbal)
Flexibility - the ability to troubleshoot and triage challenges
Computer proficiency (desktop software, MS office).
A valid driver's license.
Must pass a vision exam and be free of color blindness
Must be equivalent to 20/20 correctable close vision acuity
Time Commitments and Work Authorization
Ability to work 6pm to 6am on a 2-2-3 schedule
Must Pass a “fitness for duty” physical exam
Ability to work overtime as required
Ability to wear safety equipment (glasses, shoes, gloves, etc)
Ability to work and gown in a cleanroom (Grade C, ISO 8) environment.
Ability to participate in professional development opportunities (team coursework such as classes through RCCC)
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.
Experience with, completion of, or understanding of:
Leadership and the ability to train / educate team members
STEM degree or certifications
Aseptic filling, single use assemblies, isolator technology.
Formulation, dispensing, material preparation.
Automated, semi-automated, and/or manual inspection.
Knowledge of current Good Manufacturing Practices (CGMPs)
Experience in operations or manufacturing environments.
Pharmaceutical, medical device or food processing industries
Manufacturing Execution Systems and electronic batch release.
Continuous improvement (Lean, Six Sigma methodologies)
Highly automated equipment (inspection, packaging, filling, assembly, etc)
SAP, Electronic Batch Records
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
Auto-ApplyAssociate - Continous Improvement Leader - QA Batch Disposition
Concord, NC 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.
Job Summary
The Continuous Improvement Leader - QA Batch Disposition Team assures patients worldwide of safe and efficacious drug and device products, through effective quality oversight of site activities. The Continuous Improvement Leader - QA Batch Disposition is responsible for driving operational excellence through Lean, Six Sigma, and other continuous improvement methodologies. This role partners with cross-functional teams to identify inefficiencies, implement solutions, and foster a culture of continuous improvement that delivers measurable results in quality and productivity, while also performing the role of an Authorized Quality Representative as required.
Key Responsibilities
Develop and execute a site-wide continuous improvement strategy for batch disposition aligned with business objectives.
Facilitate Kaizen events, Value Stream Mapping sessions, and other workshops to identify and eliminate waste in the batch disposition process.
Lead structured problem-solving initiatives using DMAIC, PDCA, and root-cause analysis tools and implement sustainable solutions developed locally and globally.
Analyze operational data (OEE, cycle time, throughput) to identify improvement opportunities in the batch disposition process.
Support training and coaching of batch disposition team members as needed.
Track and report progress of improvement projects, including KPI performance.
Promote a culture of operational excellence through visual management and standard work for the batch disposition team.
Mentor internal team and develop future leaders in continuous improvement.
Develop and manage weekly, monthly, quarterly targets for batch disposition.
Perform final release of device assembly and packaging products as required.
Ability to work overtime as required, including nights and weekends as required.
Other duties as assigned/required.
Required Qualifications
Bachelor's degree in STEM.
Experience in batch disposition and leading continuous improvement initiatives in manufacturing, supply chain, or similar environments.
Strong analytical skills with proficiency in data analysis and process metrics.
Excellent communication, leadership, and change management skills.
Experience with ERP/MES systems and data visualization tools.
Ability to influence and engage stakeholders at all organizational levels.
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
$65,250 - $169,400
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
Auto-ApplyMaintenance Technician - Night Shift
Concord, NC 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.
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)
• Shift Bonus for Weekend hours
• Sign-on bonus
For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.
Responsibilities:
The focus of the Maintenance Technician - Night Shift is to provide maintenance expertise to service, repair, and maintain process and utility other pharmaceutical manufacturing equipment currently in service.
The Maintenance Technician - Night Shift is expected to understand the needs and requirements of the customer (Operations); must be able to work effectively with customers, handle customer questions with tact and understanding while displaying good customer service.
Key Objectives/Deliverables:
• This role is expected to improve equipment uptime, line efficiency, and increase overall equipment effectiveness in a production environment by condition monitoring, troubleshooting, and assisting in engineering changes.
• Must possess a good mechanical aptitude to troubleshoot and repair equipment while, following departmental rules and regulations.
• Must be willing to work with safety as a primary focus and abide by applicable safety procedures and practices.
• Troubleshoot the root causes of machine problems (e.g., excessive vibration or temperature, bearing failures, abnormal noises, and poor performance).
• Perform repairs and overhaul equipment (e.g., gear boxes, pumps, blowers, fans and drives) to include disassembly, setting tolerances, aligning, resetting timing (e.g., air compressors, vacuum pumps)
• Setup equipment to design specifications (e.g., timing, leveling, alignment)
• Operate precision alignment equipment (e.g., Roma-align, lasers, etc.)
• Must have the ability to quickly and accurately diagnose the root cause of a problem and implement the proper corrective actions to minimize downtime.
• Must accurately document the actions taken to repair the equipment in the CMMS program.
• Willing to assist in areas outside of their primary responsibility and learn other skills, as required
Basic Qualifications:
• High school diploma/GED
• Minimum 2 Years of Maintenance
• 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
• Must satisfy background check and drug screening requirements.
Additional Skills/Preferences:
• Must be able to speak, read and write English at a sufficient level to communicate technical and business information effectively.
• Must be able to effectively use business software programs, such as, Maximo, Microsoft Outlook, Microsoft Office Suite and other required software programs.
• Must be able to effectively work in a team environment.
• Physical considerations include the ability to work with or around equipment, climb ladders and stairs and use PPE (Personal Protective Equipment). He/she may be exposed to harsh weather conditions as part of the job.
• Good, all-around hands-on experience with repair of equipment.
• Use basic trouble shooting equipment such as multi-meters, calipers ect.
Additional Information:
• Overtime may be required during shutdowns, emergency situations, or periods of heavy workloads.
• The Maintenance Technician - Night Shift will work in and around potentially dangerous and hazardous equipment, powders, liquids and gases. Safety is paramount for this position.
• Night shift role. Will transition to a night shift 12-hr 2-2-3 schedule in the future. For the training period, it will be a day shift role.
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
$21.27 - $41.25
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
Auto-ApplyPharmaceutical Sales- Associate Territory Manager- Cardiometabolic Health
Rock Hill, SC 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.
Territory position- ROCK HILL, SC CMH1 - 170243
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.
The Territory Manager will be accountable for account-based selling to health care providers (HCPs) who prescribe and influence the treatment for the disease states represented in the Lilly portfolio. This includes customers in multiple HCP specialties, as well as representatives in key hospital accounts. They will be viewed as a credible expert and resource supporting all medicines and appropriate brand patients.
The Territory Manager will be accountable for driving results by embracing Lilly's suite of models: Lilly Selling Model, Lilly Competency Model and Account Management Model to meet the needs of customers through strong execution. Territory Managers will drive consistent ways of working within the Regional Healthcare Market. They will build relationships with key customers to drive utilization and adoption of our medicines for the right patients. Specific responsibilities include the following:
BUSINESS OWNERSHIP • Promotes the full portfolio of priority products with multiple HCP specialties. • Understands the marketplace within the territory; evaluates and tailors the territory strategy to grow and own business outcomes. • Navigates the ever-changing healthcare environment and payer landscape to increase understanding of accounts and be able to impact key stakeholders to become trusted partners. • Utilizes appropriate business insight tools, data, and analytics to identify trends, priorities, opportunities, and potential obstacles. • Implements and adopts new technologies, including the integration of AI company-approved tools and other analytical capabilities to streamline customer interactions. • Identifies and advocates for new opportunities to enhance the customer experience.
• Models a growth mindset to create positive experiences.
SELLING SKILLS / CUSTOMER EXPERIENCE • Embraces and uses the company's selling, competency and account management models to elevate performance and drive results. • Demonstrates high learning agility to understand disease state, marketplace, clinical trials, and product label. • Promotes the BU portfolio by planning for and engaging in patient-centered dialogues with customers.
EXECUTION / RESULTS • Promotes across BU-portfolio and across HCP specialties, driving consistent ways of working within the Regional Health Care Market to meet customers' needs. Appropriately, fully utilizes the Virtual Medical Hub. • Achieves targeted sales and execution metrics while adhering to company policies and procedures. • Owns the customer relationship for product promotion, on-label medical questions, and general market access. • Holds self-accountability for results and performance across all accounts, from individual HCPs to large health systems. • Builds and maintains relationships with both internal and external partners to foster trust and create collaborative success.
BASIC QUALIFICATIONS
• Bachelor's degree.
• Professional certification or license required to perform this position if required by a specific state.
• Valid US driver's license and acceptable driving record is required.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role.
ADDITIONAL SKILLS / PREFERENCES
• Demonstrated business ownership skills, selling/customer experience skills, and execution/results.
• Account based selling experience. Ability to identify and engage staff members in accounts.
• Strong learning agility, self-motivation, team focused, and emotionally intelligent.
• Bilingual skills as aligned with territory and customer needs. • Residence within 30 miles of the territory boundary.
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 - $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
Auto-ApplyPrincipal Engineer TSMS Validation
Concord, NC 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.
Principal Engineer TSMS Validation - Eli Lilly and Company
Job Summary
We are seeking a highly experienced Principal Engineer to lead and execute validation activities for our Global TSMS (Technical Systems Management System) initiatives.
Responsibilities
Validation Leadership: Lead the development, execution, and review of validation strategies, plans, protocols, and reports for complex TSMS projects, ensuring adherence to regulatory requirements.
Technical Expertise: Provide expert technical guidance on validation methodologies, data integrity principles, GxP regulations, and industry best practices related to computerized systems, automation, and manufacturing process controls.
Project Management: Manage validation deliverables across multiple projects, collaborating with cross-functional teams including IT, manufacturing, quality assurance, engineering, and external vendors to ensure timely and effective project completion.
Risk Management: Develop and implement risk-based validation approaches, identifying potential risks to system functionality, data integrity, and compliance, and proposing effective mitigation strategies.
System Lifecycle Management: Contribute to the full lifecycle management of TSMS, from initial design and development through implementation, maintenance, and decommissioning, ensuring continuous validation status.
Documentation and Compliance: Ensure all validation documentation is accurate, complete, auditable, and compliant with regulatory expectations and company policies. Participate in regulatory inspections and internal audits as a subject matter expert.
Continuous Improvement: Proactively identify opportunities for process improvement within TSMS validation, driving efficiency and effectiveness in our validation practices.
Mentorship and Training: Mentor engineers and provide training on validation principles and company procedures.
Qualifications
Education: Bachelor's degree (e.g., Chemical, Electrical, Computer Science), Computer Science, or a related scientific discipline.
Experience: Minimum of 5 years focused on sterilization or cleaning validation.
Technical Skills:
Strong understanding of manufacturing processes and control systems (e.g., Pharma suite, Maximo,).
Experience with various validation tools and methodologies.
Proficiency in authoring and reviewing complex validation documentation.
Leadership and Communication:
Proven leadership skills with the ability to influence and guide cross-functional teams.
Excellent written and verbal communication skills, capable of effectively presenting complex technical information to diverse audiences.
Strong problem-solving and analytical abilities with a keen attention to detail.
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
Auto-ApplyTS/MS Engineer - Cleaning Validation/Sterilization Validation
Concord, NC 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.
Lilly unites caring with discovery to create medicines that make life better for people around the world. Lilly is a Fortune 500 company that has been in operation for over 140 years. We make medicine with safety first and quality always while living our company values of Integrity, Excellence, and Respect for People.
Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located in Concord, North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and technical organization from the ground up.
The Principal Scientist/Engineer - Cleaning Validation/Sterilization Validation - Technical Services / Manufacturing Science (TS/MS) role is a technical position that develops and supports the validation of production equipment and systems and provides technical leadership regarding temperature mapping, cleaning and sterilization validation strategies.
Primary objectives include the start-up and compliant manufacturing of products, particularly as it relates to development and implementation of validation strategies, including sterilization validation, cleaning validation, filter validation, and other related activities. The scope of the role includes device assembly, packaging, and syringe filling operations for commercially manufactured products targeted for transfer to the Concord site.
Key Objectives / Deliverables:
· Understand the scientific principles required for manufacturing parenteral drug products, device assembly and packaging, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.
· Provide technical support for all start-up activities related to temperature mapping, cleaning and sterilization programs.
· Development and execution of cleaning and sterilization strategies that focus on the validation of production equipment and systems (e.g., tanks, component/parts washer, autoclaves, filling isolators, etc).
· Support periodic requalification activities for production equipment and systems.
· Author and support the execution of validation protocols and reports.
· Provide technical guidance to the Process Team for cleaning and sterilization processes.
· Lead or provide technical support for root cause investigations related to cleaning, sterilization, and other related activities.
· Analyze manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.
· Coordinate with cross-functional process teams for the implementation of projects identified to improve productivity, quality, or continuous improvement of cleaning and sterilization processes.
· Participate or provide guidance for equipment cleaning and sterilization programs during internal and external audits, including regulatory inspections, as needed.
· Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, QPPAs, etc.
· Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda.
· Serve as cleaning and sterilization interface external to the Concord site.
· Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives.
· Collaborate with and influence partners across the Parenteral Network and teams along a specific product supply chain.
· Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.
Minimum Requirements:
· BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
· 3+ years experience supporting cGMP manufacturing (specifically within validation, engineering, technical services/MSAT, operations, quality assurance, etc.)
Additional Preferences:
· In depth knowledge of parenteral drug product manufacturing
· Experience executing equipment qualification, cleaning validation, and sterilization validation
· Demonstrated successful leadership of cross-functional teams
· Experience with data trending and analysis
· Ability to analyze complex data and solve problems
Other Information:
· Role is Monday through Friday based.
· Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.).
· Occasional extended hour and / or off-hour work may be required.
· Position will be based out of Concord site with ability to travel to Indianapolis and other global Lilly sites 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
$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
Auto-ApplyAssociate - Operational Excellence Site Business Partner
Concord, NC 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.
Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site, in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Concord site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don't want to miss!
The OpEx team provides leadership in operational excellence and continuous improvement efforts by combining knowledge of pharmaceutical manufacturing with OpEx principles and tools.
The focus of the OpEx Site Business Partner role is to partner with all organizational levels across local and global business to deploy operational excellence standards and support both event and nonevent-based continuous improvement. Results include, but are not limited to, cycle time reduction, increased asset effectiveness, cost reduction, improved quality, as well as increased employee morale at all levels due to more time being spent on patient value-added activities.
Key Role Deliverables:
Provide direct support for operational excellence/ continuous improvement projects with functional areas/departments in support of site production targets and delivery of site agenda.
Establish and support implementation of lean manufacturing initiatives in alignment with the Lilly Manufacturing Standards of Operational Excellence (MSOEs).
Monitor/build a strong safety culture and hold others accountable while leading by example.
Ensure consistency of operations across shifts through active engagement on the shop floor through Gemba walks (Practice vs. Procedure evaluations).
Lead cross functional teams in the development and implementation of the following problem-solving methodologies and initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Value Stream Mapping, A3 etc.
Deliver necessary information and data about the new/ongoing CI projects.
Facilitates problem-solving, shared learning and decision-making across plant functions
Responsible for schedule tracking, updating, and reporting to all stakeholders for CI projects.
Responsible for assembling Continuous Improvement (CI) project plans, teamwork assignments, directing and monitoring work efforts daily.
Escalates technical and timeline issues appropriately for CI projects.
Identifies issues that may delay project deliverables and recommend risk mitigation strategies, contingencies, and actions, when appropriate.
Other duties as assigned.
Systems & Strategies - Design and Governance:
Lead the establishment of operational excellence systems within the operational organization, including Daily Management System (DMS) to drive process improvement or streamline operational activities to increase operational efficiencies.
Facilitate and execute the process of systems governance and assessment (Lean Maturity Assessment; Site CI OpEx Self-Assessments)
Capture benefits of operational excellence improvement program and report to site leadership
Assisting in Engagements:
Lead and / or partner on a variety of engagements, within the site/function as well as network level within Manufacturing and Quality. Driving the process / projects to completion.
Lead and coach process improvement opportunities and projects according to selected methodology (Kaizen Event, A3, etc…)
Provide support to ensure robust Organizational Change Management and Monitoring Plans are in place to sustain improvements.
Engage routinely with sponsors to provide status updates and escalate where appropriate as issues arise.
Ensure Lean principles and tools are integrated into both project execution and solution design.
Partner with site leadership/ other functions, including site lead team and other governance forums, to identify and prioritize major productivity improvement opportunities. Leverage internal and external networking.
Instructing and Training Others:
Facilitate CI & OpEx training to all levels of employees within assigned areas to support deployment and ongoing sustainability of CI and OpEx / Lean ways of working.
Minimum Requirements
Demonstrated strong written and oral communication and interpersonal interaction skills to be able to work effectively in a team-based environment.
Strong self-management and organizational skills.
Ability to coach individuals at all levels, and lead project teams
Ability to influence without authority.
Relevant operations experience in a GMP facility.
Pharmaceutical experience
Knowledge of cGMPs
Experience in lean manufacturing or other productivity industry methods
Bachelor's or equivalent
Day shift with possible after hour support
Project delivery may coincide with company holidays
Occasional travel may be required for training, conferences, project facilitation, 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
$58,500 - $137,500
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
Auto-ApplySupervisor - Aseptic Filling (Day Shift)
Concord, NC 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.
Position Description:
Company Overview
At Lilly, we unite caring with discovery to make life better for people around the world. We are a 140+ year strong global healthcare leader headquartered in Indianapolis, Indiana with manufacturing sites throughout the US, EU, and Asia. Our 35,000 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 and embody our company values of Integrity, Excellence, and Respect for People
Position Overview
Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company's capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site.
If you ever wanted to have a direct impact building a team's culture and in how the team operates, now is the perfect opportunity!
During the project phase, the Operations Supervisor (Filling) will have responsibility of supporting start-up activities to bring the Parenteral (PAR) area into service. The PAR department will have ownership of product formulation, aseptic isolator barrier filling, and visual inspection operations. Activities will include coordinating start-up support amongst self and team to; train on the use of the equipment and develop technical proficiency, develop a diverse and inclusive culture, and lead operational readiness activities. This position will require travel domestically (2-4 week trips and/or 3-12 month short term assignments) with the opportunity for travel internationally to collaborate and learn from sites who produce our medicines currently.
Once the facility is turned over to operations, the Supervisor role is responsible for leadership of the team that operates the multiple PAR departments. They will develop an inclusive culture and technical expertise of manufacturing team and employees. This individual will ensure that the lines are adequately staffed with trained & qualified employees. Strict adherence to safety and quality rules and procedures is expected. Direct line supervision for this role includes line leaders and operators.
As a site leader and expert at our growing site, you'll have significant opportunities for growth into future leadership and technical roles.
Key Objectives / Deliverables:
Integrity
Leading by examples with a Safety first, Quality Always mindset. Comfortable with exercising and encouraging "Stop Work Authority" for all employees if there is a perceived unsafe or product impacting situation.
Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals.
Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques.
Excellence
Collaborate with area supervisors to ensure a high standard of; communication, best practice sharing, and consistency across the groups and different shifts.
Responsible for shop floor execution as it relates to business plan, cGMP conformance, and Operational Standards for Manufacturing Excellence.
Striving and encouraging a mindset of continuous improvement. Gathering ideas for improvement, articulating their business value, and working with support team to implement the ideas with highest objective value.
Ensures there are enough adequately trained and compliant personnel staffed to meet production goals. Reviews and updates training plans as needed to maintain compliance and excellence.
Develop area documentation (procedures, work instructions, job aides, etc.) with team to support start-up, training, and operation.
Originate & Investigate deviations, operational quality issues, and support determination of root cause. Support implementation of corrective actions to ensure consistent quality.
Respect for People
Support the site in building a diverse, empowered, and capable team.
Responsible for managing several direct reports working across multiple manufacturing lines on responsible shift.
Responsible for the coaching, development, and performance evaluation of operators.
Communicate cross functionally with support team if there are quality, equipment, operational concerns.
Requirements (Education, Experience, Training):
Education, Experience and Skills
High School Diploma or equivalent
Prior supervisory experience
Basic computer skills (desktop software, MS Office) are required.
Previous experience in operations or directly supporting a manufacturing operation (Pharma, Food, Clean-room, or other applicable).
Excellent interpersonal, written, and oral communication skills
Strong organizational skills and ability to handle and prioritize multiple requests.
Strong technical aptitude and ability to train and mentor others.
A valid driver's license
Time Commitments and Work Authorization
Ability to work overtime as required
Willingness to work a 12-hour day shift (6am to 6pm on 2-2-3 schedule)
Ability to wear safety equipment (glasses, shoes, gloves, etc)
Ability to work and gown in a cleanroom (Grade C, ISO 8) environment.
The position may require a short-term assignment of 3-12 months domestically or internationally to train and be certified on existing processes and establish global contacts. There may also be a requirement for short (less than 1 month) travel to support equipment testing at the manufacturer's factory.
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.
Preferred attributes but not required:
Experience with, completion of, or understanding of:
4+ years in manufacturing/operations with 2+ years in supervisory role
cGMP standards and FDA (or other industry) guidelines for production
STEM degree or certification
Aseptic filling, single use assemblies, isolator technology.
Automated, semi-automated, and/or manual inspection.
Highly automated equipment (inspection, packaging, filling, assembly, etc.)
Manufacturing Execution Systems and SAP or other electronic business systems
Continuous improvement methodologies and mindset - lean, six sigma, etc.
Root cause analysis and implementing corrective actions
Ability to organize and motivate teams
Facility, Equipment, Systems, Start-up
This job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the 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
$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
Auto-ApplySr. Principal Scientist - Sterility Assurance Floor Leader
Concord, NC 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.
For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.
Responsibilities:
The Sr. Principal Scientist - TSMS Sterility Assurance Floor Leader is responsible for providing technical leadership, management and mentorship for a team of sterility assurance scientists and technical staff while ensuring compliance with regulatory requirements and industry best practices.
Primary objectives include leading and developing a team of sterility assurance scientists (process team) which support floor activities associated with start-up and compliant manufacturing of Concord products, particularly as it relates to development and implementation of sterility assurance strategies, including environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, and sterility assurance risk management. The scope of the role includes syringe filling operations for commercially manufactured products targeted for transfer to the Concord site.
Key Objectives/Deliverables:
Lead, develop, coach, and mentor a team of sterility assurance scientists (process team) to ensure technical depth and an engaged, inclusive workforce.
Foster a collaborative workplace and ensure effective hiring and staffing.
Provide day-to-day oversight for the sterility assurance scientists (process team) associated with routine operations and start-up/project objectives.
Provide technical expertise and guidance in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization strategies.
Collaborate cross-functionally with the area process teams for operational support and provide technical guidance for root cause investigations and deviation management.
Lead sterility assurance related technical projects to improve process control, yield, product quality, and productivity.
Author, review, and approve site plans, studies, and technical documents related to sterility assurance.
Use risk management principles to evaluate processes and controls related to sterility assurance.
Analyze microbial and manufacturing data using statistical principles to identify trends and process disruptions.
Ensure audit and inspection readiness; support regulatory inspections, submissions, and partner/internal audits.
Basic Qualifications:
BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
Prior experience in cross functional technical leadership roles.
In depth knowledge of parenteral drug product manufacturing, with a focus on Sterility Assurance
5+ years supporting cGMP manufacturing (specifically within operations, environmental monitoring, sterility assurance, validation, microbiology, TSMS, QA, etc.)
Additional Skills/Preferences:
Strong interpersonal and teamwork skills
Strong self-management and organizational skills
Strong oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization
Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations
Demonstrated successful leadership of cross-functional teams
Experience with data trending and analysis
Ability to analyze complex data and solve problems
Additional Information:
This position is tech ladder approved (R4).
This position will be required to collaborate with peers across the network (Indianapolis, EU, RTP, etc).
Role is Monday through Friday. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and /or off-hour work may be required.
This is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the . For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the 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
$117,000 - $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
Auto-ApplyEngineering Technician - Day Shift
Concord, NC 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.
Engineering Technician - Day Shift
Organization Overview
At Lilly, we unite caring with discovery to make life better for people around the world. Headquartered in Indianapolis, Indiana, we are a global leader in healthcare, committed to discovering life-changing medicines, advancing disease management, and supporting our communities through philanthropy and volunteerism. We put people first and strive to make a meaningful impact every day.
Position Summary
The Engineering Technician at our Concord, NC facility plays a key role in supporting Parenteral Operations, our customer, by ensuring the efficient setup and operation of Pre-Filled Syringe and Isolator Equipment. This position requires hands-on engineering maintenance expertise to assist with equipment setup, operational support, troubleshooting, repairs, and ongoing maintenance.
The ideal candidate will demonstrate a strong understanding of customer needs, collaborate effectively with internal teams, and provide responsive, courteous support. Success in this role requires technical proficiency, problem-solving skills, and a commitment to delivering excellent customer service in a dynamic manufacturing environment.
Key Responsibilities
Promote a safety-first, quality-always culture in all tasks and interactions
Improve equipment uptime, line efficiency, and overall equipment effectiveness (OEE)
Perform condition monitoring, troubleshooting, and provide operational support
Diagnose and repair precision filling equipment with strong mechanical aptitude
Collaborate with engineering and production teams to resolve equipment issues promptly
Assist with equipment setup and changeovers to support production needs
Adhere to all GMP and quality standards
Must have the ability to quickly and accurately diagnose the root cause of a problem and properly implement corrective actions to minimize downtime
Accurately document maintenance activities and corrective actions
Support cross-functional tasks and assist outside primary responsibilities as needed
Work independently and manage priorities under pressure
Basic Requirements
High school diploma or GED
Minimum of 5 years' experience in production maintenance
Preferred Qualifications
Strong mechanical aptitude and hands-on technical skills
Proficient with basic hand tools
Detail-oriented with a commitment to quality and precision
Familiarity with safety protocols and proper PPE usage
Physically able to stand for extended periods
Effective team player with strong interpersonal skills
Associate's degree or technical certification in a related field is a plus
Knowledge of FDA and GMP regulations
Experience operating high-speed, automated production equipment, preferably Syringe/Vial Filling systems utilizing Isolator technology
Ability to quickly learn and apply new procedures
Experience working in a classified manufacturing environment
Familiarity with Computerized Maintenance Management Systems (CMMS) platforms
Strong verbal and written communication skills
Customer-oriented mindset with a proactive approach
Analytical thinker with strong problem-solving abilities
Additional Information
Flexibility to work overtime or adjust schedule based on production demands
Following a Monday-Friday, 8-hour training period, the role transitions to a 12-hour 2-2-3-day shift schedule
Willing and able to respond to off-hour emergencies as needed
Open to travel for training and professional development opportunities
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
$21.27 - $41.25
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
Auto-ApplyAssociate Director, Parenteral Operations
Concord, NC 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.
Position Description
Company Overview
At Lilly, we unite caring with discovery to make life better for people around the world. We are a 140+ year strong global healthcare leader headquartered in Indianapolis, Indiana with manufacturing sites throughout the US, EU, and Asia. Our 35,000 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 are looking for people who are determined to make life better for people around the world and embody our company values of Integrity, Excellence, and Respect for People
Position Overview
Lilly is investing over $1 Billion to build a completely new, inspiring, and highly automated campus in Concord, North Carolina which will house warehousing & logistics, operations including parenteral, medical device assembly, and packaging, QC laboratories, and support teams to produce medicines for an unmet patient need.
If you ever wanted to have a direct impact on building a team's culture and on how the team operates, now is the perfect opportunity!
During the project phase, the Associate Director (AD), Operations is responsible for staffing, training, and leadership of the operations group supporting asset delivery, process development, operations readiness, start up, and validation of the parenteral operations (PAR) areas which include formulation, aseptic isolator barrier filling, and visual inspection areas. This position will require travel domestically with the opportunity for travel internationally to collaborate and learn from sites who produce our medicines currently
Once the facility is turned over to operations, the AD role is responsible for ensuring the group meets annual production goals as well as planning through 1-3 year horizons. They are expected to lead by example and provide coaching to others in the areas of safety, quality, operational excellence, compliance, and continuous improvement. The AD will be responsible for leading their respective cross-functional process teams. Direct line supervision for this role includes Supervisors and Operations Associates.
As a site leader and expert at our growing site, you will have significant opportunities for growth into future leadership and technical roles.
Key Objectives / Deliverables
Integrity
Leading by example with a Safety first, Quality Always mindset. Comfortable with exercising and encouraging "Stop Work Authority" for all employees if there is a perceived unsafe or product impacting situation.
Lead/conduct area deviation and corrective action discussions with a cross-functional team from Engineering, Maintenance, Technical Services / Manufacturing Sciences (TS/MS), Quality, and Health, Safety, and Environmental (HSE) functional groups
Present operations investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert (SME) for related inspections, tours, and discussions.
Excellence
Ensure consistency of operations across shifts through active engagement on the shop floor, Gemba walks, and Practice vs. Procedure evaluations.
Maintain and communicate metrics to measure performance against business objectives and make necessary changes to continuously improve.
Participate in the development and implementation of strategies focused on the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE).
Understand and influence the manufacturing control strategy for their area.
Respect for People
Support Site Leadership to build a diverse and capable site organization while delivering area operational procedures, quality processes and controls for the Parenteral manufacturing area.
Responsible for a work force of approximately 40 - 70 individuals on various shifts, with multiple shift supervisors and associates reporting directly to them.
Provide leadership and develop objectives to deliver Business Plan goals as it relates to production volumes, finances, safety, quality, stewardship, and people.
Act as a primary contact for other areas such as Production Planning, HR, Quality Assurance, Engineering and Environmental/Safety.
Leading the Operations Process Team, a cross functional group charged with making medicine, continuous improvement, and site support.
Represent their Operations Process Team on the Plant Flow (value stream) Team.
Requirements (Education, Experience, Training)
Education, Experience, and Capabilities
Bachelor's degree in a STEM or pharmaceutical related field of study.
At least 7 years working in the pharmaceutical industry.
Previous management or leadership experience including leading or working effectively with a cross functional group.
Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and/or OSHA.
Excellence in; interpersonal, electronic, written, and oral communication
Strong technical aptitude and ability to train and mentor others
Time Commitments, Environment, and Work Authorization
Ability to wear safety equipment (glasses, shoes, gloves, etc)
Ability to work 8 hours per day Monday through Friday with overtime as required to meet key objectives.
Position will involve frequent business trips domestically with potential international travel to support testing of equipment at vendor sites, visit Lilly sites to learn and collaborate, and to build global network.
Travel domestically and internationally, up to approximately 20% of the year to learn and network with colleagues.
Preferred attributes but not required
Experience with, completion of, or understanding of:
6+ years in manufacturing/operations with 4+ years in supervisory role
cGMP standards and FDA (or other industry) guidelines for production
Aseptic filling, single use assemblies, isolator technology.
Automated, semi-automated, and/or manual inspection.
Highly automated equipment (inspection, packaging, filling, assembly, etc.)
Creation of standard operating procedures, work instructions, and training documentation.
Equipment & Facility design documentation reviews
Facility, equipment, or system start up.
Qualification and process validation experience.
Manufacturing Execution Systems and electronic batch release.
Automated Storage and Retrieval System (ASRS) Warehouses or AGVs.
Continuous improvement methodologies and mindset - lean, six sigma, etc.
Documentation, deviation and change management systems (e.g., Trackwise. Veeva, QualityDocs, Kneat)
This job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the 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
$123,000 - $180,400
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
Auto-ApplyDirect Sales Representative, ICM - Charlotte/Raliegh/Wilmington, NC
Abbott Laboratories job in Charlotte, NC
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:
* Career development with an international company where you can grow the career you dream of.
* Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
* An excellent retirement savings plan with a high employer contribution ·
* Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
* A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
* A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position is a field-based position can be based in Charlotte; Raliegh; Wilmington, NC the ICM Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias or irregular heartbeats.
What you will work on
We are seeking a dynamic and results-driven Medical Sales Representative to join our team to promote and sell Abbott's Insertable Cardiac Monitor (ICM) medical devices. In this role, you will be responsible for promoting and selling ICM devices to physicians, medical laboratories, distributors, and hospitals within an assigned territory. Your efforts will contribute to the growth and success of Abbott's CRM product lines.
Key Responsibilities
* Contacts, visits and educates clients and potential clients on the Company's products and addresses any client questions and concerns.
* Builds and executes on business plans in partnership with management to identify, target and develop new accounts.
* Provides medical professionals with information and training on the use of Company products and with staff education, in-services and technical troubleshooting.
* Ensures that all pertinent patient information is completed and forwarded to patient tracing when required.
* Responsible for the management of physical inventory located within assigned territory.
* Collects and studies information about new and existing products and monitors competitor sales, prices and products.
* Analyses sales statistics; prepares reports; and performs required administrative sales duties, e.g., filing expense account reports, scheduling appointments, and making travel plans.
* May attend trade shows where new products and technologies are showcased and conferences to meet other sales representatives and clients and discuss new product developments.
* Prepares special analyses as required.
* Remains current on developments in field(s) of expertise.
* Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
* Performs related duties, on occasion, as assigned or required.
Qualifications
* Bachelor's degree in a relevant technical field or equivalent and typically two plus years of sales or clinical support experience with proven experience influencing customers in a healthcare-related setting.
* An aptitude to analyze and evaluate technologically complex devices; ability to work with and direct others effectively; ability to prepare and present strong written and verbal communications; familiarity with medical device industry policies, operations and procedures.
* Documented record and/or aptitude of delivering sales/marketing information to influence customer decision-making
* Ability to establish and maintain good working relationships with customers, physicians, hospital administrators, government agencies, medical groups, and other sales representatives.
* Strong verbal and written communication, negotiation, sales, interpersonal and presentation skills. Demonstrated working knowledge of frequently used personal computer programs and relevant applications.
* Prefer general understanding of cardiac rhythm management technology.
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: **********************
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at *************** on Facebook at *********************** and on Twitter @AbbottNews.
The base pay for this position is $41,400.00 - $102,900.00. In specific locations, the pay range may vary from the range posted.
Auto-ApplySr. Manager, Professional Education - JJMT Neurovascular
Charlotte, NC job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Medical Affairs Group
Job Sub Function:
Professional Medical Education
Job Category:
People Leader
All Job Posting Locations:
Albuquerque, New Mexico, United States of America, Albuquerque, New Mexico, United States of America, Anchorage, Alaska, United States, Atlanta, Georgia, United States, Baton Rouge, Louisiana, United States, Boise, Idaho, United States, Boston, Massachusetts, United States of America, Burlington, Vermont, United States, Camden, New Jersey, United States, Cedar Rapids, Iowa, United States, Charleston, South Carolina, United States, Charleston, West Virginia, United States, Charlotte, North Carolina, United States, Charlottesville, Virginia, United States, Chicago, Illinois, United States, Columbia, Maryland, United States, Columbus, Ohio, United States, Dallas, Texas, United States, Denver, Colorado, United States, Detroit, Michigan, United States, Fargo, North Dakota, United States, Gulfport, Mississippi, United States, Helena, Montana, United States, Honolulu, Hawaii, United States, Indianapolis, Indiana, United States {+ 23 more}
Job Description:
Johnson & Johnson MedTech - Neurovascular division is currently seeking a Senior Manager of Professional Education. This is a remote role within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. This role also requires up to 60% overnight travel.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/.
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech/
Position Summary:
As the Senior Manager, Professional Education (US), you will be instrumental in creating strategic training initiatives that ensure the safe and effective use of J&J Neurovascular products. Reporting directly to the Director of Education, you will oversee a dynamic team of managers and specialists, collaborating with multiple cross-functional partners including Marketing, Medical Affairs, Clinical Teams, Regulatory Affairs, and Sales Leadership.
Your leadership will drive the design, execution, and continuous improvement of a comprehensive educational curriculum targeting healthcare providers - from physicians and residents to allied health professionals such as NPs, PAs, RNs, and RTs.
You will establish strong, consultative relationships with our KOL faculty, leaning on their expertise to elevate our training programs, driving creativity to be best in class and including the newest and next technologies.
The Senior Manager-US Professional Education is primarily aligned to the US, but must be cognizant of the global strategy, and may be consulted for regional business needs.
Key Responsibilities:
* Design and execute all aspects of Professional Education programs to ensure the safe and effective use of JNJ MedTech Neurovascular products and technology.
* Collaborate with cross-functional business partners and key stakeholders to develop and execute impactful educational programs that support the US Business Plan, in conjunction with New Product Introductions (NPI) Launch Excellence (LEX) Reviews.
* Maintain oversight of Professional Education discretionary budget with manager and Finance partners, inclusive of Team T&E and sample product forecast.
* Stay current on company products instructions for use (IFU), best practices and technical troubleshooting, as well as relevant scientific clinical literature and new product information.
* Keep current of the competitive market, treatment trends, technology, competitors, treatment guidelines and new regulations.
* Identify and develop strong relationships with KOL faculty and oversee all consulting HCP & Facility agreements, Faculty Time Records, Faculty Payments, and execution of all planned training programs and activities.
* Evaluate and implement innovative training modalities, which meet the needs of the learner, i.e. web-based applications and technology-based tools, AI platform, AR/VR, Telementoring,
* Maintain the required training documents that fulfill the FDA training commitment for TRUFILL n-BCA Liquid Embolic System and Enterprise Vascular Reconstruction Device with Clinical Affairs, Regulatory, and Legal teams.
* Oversee development and progressive learning stages of the Johnson & Johnson Institute comprehensive and scalable curriculum for Fellows, Residents, and Allied Health Professionals
* Operate under limited supervision and in strict adherence to applicable company guidelines on Regulatory, Health, Safety, and Environmental practices.
* Align with established project and management processes, instruction design standards and processes, and corporate brand style and standards, including compliance requirements.
Qualifications:
Required:
* Bachelor's degree is required.
* Minimum of ten (10) years of relevant business experience (Professional or Commercial Education, Marketing, Sales, and Clinical.
* Minimum of three (3) years of experience working in organizational learning or a Professional or Commercial Education environment.
* Ability to effectively communicate with customers (physicians) and internal stakeholders with demonstrated presentation skills and written communication skills, as well as solid organizational and time management abilities.
* Ability to champion product concepts and promote change through indirect influence.
* Ability to work independently, requiring limited oversight.
* Ability to collaborate well with cross-functional partners.
* Ability to provide solutions to complex problems to enhance customer experience.
* Previous People Leader/Management experience.
* Proficient with Microsoft Outlook, Teams, SharePoint, Excel, PowerPoint, and ZOOM
Preferred:
* Neurovascular experience is strongly preferred.
* Current or previous experience launching new products.
* Comprehension of Health Care Compliance guidelines.
* This position is to be remote field based within the continental United States and may have up to 50% overnight travel in the US.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
The anticipated base pay range for this position is :
$137,000 - $235,750
Additional Description for Pay Transparency:
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. *********************************************
Auto-ApplyScientist - TS/MS Parenteral
Concord, NC 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 Scientist - TSMS PAR will initially focus on the delivery of parenteral operations, specifically regarding technical transfer and process validation. TSMS PAR Scientists will support one of either formulation, filling, or visual
inspection (VI), although may support multiple areas during start-up phase. Upon the start of commercial production, this role's objectives include maintaining the validated state of applicable processes, establishing and monitoring
metrics/methods to ensure a state of capability and control, harmonization of control strategies across process
teams, evaluate process improvement, and serving as an escalation point for day-to-day operations issues. The role will also author and execute protocols as well as conduct root cause investigations. The principal role is a position
that develops and implements a technical agenda and is responsible for providing technical leadership for the
Parenteral Process Team. The principal role expected to serve as a mentor within the TSMS team and engage in
upstream and external to site activities related to parenteral manufacturing.
Key Objectives/Deliverables:
• Support the assigned Process Team (formulation, filling, or VI) as TSMS representative. • (Associate/Senior) Serve as floor-level support and technical interface for manufacturing components, equipment, and operations for the TSMS team.
• Represent Concord TSMS team for internal and external communications on a regular basis
• Lead risk management activities as it pertains to product/process
• Provide technical support to non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability issues
• Prepare and Review or approve, as required, relevant technical documents such as: Annual Product Reviews, Change Controls, Regulatory Submissions, Deviations, Validations, Procedures, PFDs, PFMEAs, etc.
• Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability
• Identify opportunities and lead technical projects to improve process control and/or productivity
• Serve as interface with upstream suppliers and parenteral product networks
• Drive stability strategy for Concord products
• Provide Audit support as needed
• Identify opportunities and participate in projects to improve process control and/or productivity
Basic Qualifications:
• Bachelor's degree or higher an engineering, packaging science, or related field
Additional Skills/Preferences:
• Pharmaceutical and/or medical device manufacturing experience
• Root Cause Investigation Experience
• Proficiency with computer systems including Microsoft Office products, Veeva Vault, TrackWise, electronic batch records, and SAP
• Demonstrated successful leadership of cross-functional teams
• Strong interpersonal and teamwork skills
• Strong self-management and organizational skills
Additional Information:
• Role is Monday through Friday. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and /or off-hour work may be 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
$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
Auto-ApplyNight Shift Supervisor, Aseptic Filling
Concord, NC 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.
Position Overview
Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company's capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site.
If you ever wanted to have a direct impact building a team's culture and in how the team operates, now is the perfect opportunity!
During the project phase, the Operations Supervisor will have responsibility of supporting start-up activities to bring the Parenteral (PAR) area into service. The PAR department will have ownership of product formulation, aseptic isolator barrier filling, and visual inspection operations. Activities will include coordinating start-up support amongst self and team to; train on the use of the equipment and develop technical proficiency, develop a diverse and inclusive culture, and lead operational readiness activities.
Once the facility is turned over to operations, the Supervisor role is responsible for leadership of PAR operations teams. They will develop an inclusive culture and technical expertise of manufacturing team and employees. This individual will ensure that the lines are adequately staffed with trained & qualified employees. Strict adherence to safety and quality rules and procedures is expected. Direct line supervision for this role includes line leaders and operators.
As a site leader and expert at our growing site, you'll have significant opportunities for growth into future leadership and technical roles.
Key Objectives / Deliverables:
Integrity
Leading by examples with a Safety first, Quality Always mindset. Comfortable with exercising and encouraging "Stop Work Authority" for all employees if there is a perceived unsafe or product impacting situation.
Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals.
Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques.
Excellence
Collaborate with area supervisors to ensure a high standard of; communication, best practice sharing, and consistency across the groups and different shifts.
Responsible for shop floor execution as it relates to business plan, cGMP conformance, and Operational Standards for Manufacturing Excellence.
Striving and encouraging a mindset of continuous improvement. Gathering ideas for improvement, articulating their business value, and working with support team to implement the ideas with highest objective value.
Ensures there are enough adequately trained and compliant personnel staffed to meet production goals. Reviews and updates training plans as needed to maintain compliance and excellence.
Develop area documentation (procedures, work instructions, job aides, etc.) with team to support start-up, training, and operation.
Originate & Investigate deviations, operational quality issues, and support determination of root cause. Support implementation of corrective actions to ensure consistent quality.
Respect for People
Support the site in building a diverse, empowered, and capable team.
Responsible for managing several direct reports working across multiple manufacturing lines on responsible shift.
Responsible for the coaching, development, and performance evaluation of operators.
Communicate cross functionally with support team if there are quality, equipment, operational concerns.
Requirements (Education, Training, and Experience)
Education, Experience and Skills
High School Diploma or equivalent
Prior supervisory experience
Basic computer skills (desktop software, MS Office) are required.
Previous experience in operations or directly supporting a manufacturing operation (Pharma, Food, Clean-room, or other applicable).
Excellent interpersonal, written, and oral communication skills
Strong organizational skills and ability to handle and prioritize multiple requests.
Strong technical aptitude and ability to train and mentor others.
A valid drivers license
Time Commitments and Work Authorization
Ability to work overtime as required
Ability to wear safety equipment (glasses, shoes, gloves, etc)
Ability to work and gown in a cleanroom (Grade C, ISO 8) environment.
Willingness to work a 12-hour night shift (6pm to 6am on 2-2-3 schedule)
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.
Preferred Attributes:
Experience with, completion of, or understanding of:
4+ years in manufacturing/operations with 2+ years in supervisory role
cGMP standards and FDA (or other industry) guidelines for production
STEM degree or certification
Aseptic filling, single use assemblies, isolator technology.
Automated, semi-automated, and/or manual inspection.
Highly automated equipment (inspection, packaging, filling, assembly, etc.)
Manufacturing Execution Systems and SAP or other electronic business systems
Continuous improvement methodologies and mindset - lean, six sigma, etc.
Root cause analysis and implementing corrective actions
Ability to organize and motivate teams
Facility, Equipment, Systems, Start-up
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
Auto-Apply