The Production Line Mechanic is responsible for independently setting up, troubleshooting, repairing, changing over, and maintaining the production lines and facilities. He/she is responsible for product quality and employee safety and share responsibility with the Production Line Leads/Supervisors for operating production lines at top efficiency. The Production Line Mechanic always follows GMP procedures and regulations.
Responsibilities:
Sets up production equipment to run scheduled production.
Discusses difficulties in operating equipment with machine operators to isolate problems and troubleshoots machine to determine cause and repairs required.
Read and follow instructions from technical manuals and document changes in the manuals as needed and using this information to set up machine lines and adjust the conveyors.
Complete requisition forms for the parts needed to complete repairs.
Perform repairs on equipment to keep them in top running order.
Perform major mechanical overhauls of packaging equipment.
Perform preventative maintenance on equipment.
Assists with design modifications to equipment.
Provide coverage for Mechanics on other shifts, as needed.
Work with minimal supervision as well as in a team setting.
Physical demands include lifting up to 50 lbs, climbing, kneeling, balancing, lifting and moving materials, etc.
Uses hand tools for tasks.
Reads and interprets blueprints.
Measure, cut and work with materials and objects with precision.
Other duties as assigned.
Education and/or Experience:
Associates or Technical Degree or an equivalent combination of education and experience.
3 years' experience as a Maintenance Mechanic in a manufacturing environment, electrical experience is preferred.
Working knowledge of hydraulic, pneumatic, electrical functions, electrical testing equipment and machining equipment.
Knowledge of PLC software and can perform minor PLC program adjustments on equipment.
Working knowledge of arithmetic and geometry to determine dimensions and amounts of materials needed.
Benefits: Competitive Salary/ Pay & Packages, Vacations, Insurance, 401K, Life Insurance, Disability (Long term/ Short term), and Continuous Training.
To Staffing & Recruitment Agencies: Our Company does not accept unsolicited CV's or applications from agencies. We are not responsible for any fees related to unsolicited CV's or applications and explicitly reserve its right to contact candidates presented in such unsolicited CV or application.
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$44k-57k yearly est. 24d ago
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Psychiatry Area Sales Manager - Indiana
Lundbeck 4.9
Indianapolis, IN job
Target city for territory is Indianapolis - will consider candidates who live within 100 miles of territory boundaries with access to a major airport. Territory boundaries include: Grand Rapids, MI, Indianapolis, South Bend and Toledo, OH
SUMMARY:
Are you a results-driven biopharmaceutical sales leader looking to be part of an organization that values being curious, adaptable and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!
As an Area Sales Manager (ASM) you will be responsible for leading, developing, and managing a diverse, high performing sales team to achieve sales goals for promoted products within our psychiatry portfolio. Set and lead the development of area strategic direction and tactical sales plans using robust analytical skills to identify strengths and opportunities, while minimizing weaknesses and threats to execute those plans and meet or exceed sales goals.
ESSENTIAL FUNCTIONS:
Leading People
• Achieves business objectives and sales results by observing Account Manager interactions with target customers, extended treatment team members, ancillary staff and providing them with individual coaching, feedback and inspiration. Helps Account Manager continue to develop for success in current role and for future growth.
• Establishes a result driven highly collaborative team culture by demonstrating personal accountability, teamwork, and collaboration
• Leads by example and works collaboratively across functional areas by serving as a resource and by leveraging the expertise of others.
• Recruits, develops, and retains diverse, high performing Account Managers to Lundbeck.
Knowing the Business
• Guides the identification of local market systems of care, patient flow, reimbursement, and provides innovation solutions
• Identifies strategic relationships that are valuable to the area's business (e.g. KOLs, advocacy, P&T committee, etc.)
• Actively seeks to discover and meet the needs of internal and external customers by building relationships and delivering innovative solutions.
• Ensures that Account Managers can accurately craft Managed Markets selling messages to effectively position Lundbeck's products within the context of the provider's setting and payer mix.
Managing Execution
• Sets and maintains competent product knowledge and selling skills standards within the team. Directs and monitors the execution of approved marketing plans and promotion campaigns. Evaluate and identify improvement and development opportunities of account managers through performance management process to include clear, timely, and actionable feedback on a regular basis.
• Facilitates local market execution by aligning the sales force and other cross-functional areas (to include alliance partners), persuading, convincing, or motivating a targeted audience through collaboration and direct or indirect influence.
• Analyzes sales reports and develops plan of action.
• Maintains timely communication with account managers, management and in-house personnel. Manages multiple priorities and resources related to individual and group efforts. Takes responsibility for redirecting efforts as needed to deliver high productivity and quality of work from self and others.
• Assures adherence to all standards, policies, procedures and guidelines as set forth by the organization.
REQUIRED EDUCATION, EXPERIENCE and SKILLS:
• Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university
• External Candidates: Minimum of 3+ years sales management experience in Pharmaceutical, Biopharmaceutical's, Biologics or related experience.
• Internal Candidates must have a minimum of 1 year of Commercial experience in areas such as: Sales Management, Training, Market Access, Sales Operations, or Marketing or a minimum of 2 years consistent sales success within Lundbeck
• Documented track record of sales success and financial management.
• Demonstrated leadership with the ability to develop, train and provide feedback to a group of account managers.
• Must possess superior communication skills, both written and oral.
• Driving is an essential duty of this job; must have a valid driver's license with a safe driving record that meets company requirements
• Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck.
• Must live within 100 miles of territory boundaries
PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
• Previous CNS sales management experience
• Experience in calling on customers at a variety of call points, including offices, community mental health centers and hospitals
• Previous sales management experience and/or experience in other areas of the business; i.e., marketing, sales training, managed care account manager, sales operations, account management is a plus.
• Previous experience working with alliance partners (i.e. co-promotions)
• Previous experience partnering with Advocacy groups
• Previous experience building and developing effective teams
• Experience in product launch or expansion within sales
TRAVEL:
• Willingness/Ability to travel up to 70% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) attend internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner.
The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $170,000 - $195,000 and eligibility for a sales incentive target of $51,000, and eligibility to participate in the company's long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our career site. Applications accepted on an ongoing basis.
Why Lundbeck
Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.
Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site.
Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.
$170k-195k yearly 5d ago
Psychiatry Account Manager - Fort Wayne, IN
Lundbeck 4.9
Fort Wayne, IN job
Territory: Fort Wayne, IN - Psychiatry
Target city for territory is Fort Wayne - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: Fort Wayne, Noblesville, Portland and Peru.
SUMMARY:
Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!
As a Psychiatry Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with comprehensive clinical knowledge to drive sales performance. Our Account Managers are adept at executing against the toughest commercialization challenges in today's rapidly changing environment and must demonstrate strong capability in the following areas:
ESSENTIAL FUNCTIONS:
Business Planning & Account Leadership - Ability to use digital tools and apply data-based insights to create opportunities, develop strategy & tactics, allocate resources to enhance sales execution, monitor progress and adjust direction to maximize sales performance.
Selling - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior.
Customer Development - Build and maintain productive internal and external relationships based on customer needs and organizational goals, incorporating “total office” account management.
Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities.
Reimbursement - Consistently demonstrate the ability to stay informed on reimbursement dynamics, anticipate and effectively address payer access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources.
Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.
REQUIRED EDUCATION, EXPERIENCE and SKILLS:
Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university
2+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience
Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually
Self-starter, with a strong work ethic and outstanding communication skills
Must be computer literate with proficiency in Microsoft Office software
Must live within 40 miles of territory boundaries
Driving is an essential duty of this job; must have a valid driver's license with a safe driving record that meets company requirements
Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck
PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
Previous experience within a specialty product sales force.
Prior experience promoting and detailing products specific to CNS/neuroscience including: depression, schizophrenia and bipolar disorder
Documented successful sales performance
Ownership and accountability for the development and execution of fully integrated account plans
Strong analytical background, and experience using sales data reporting tools to identify trends
Experience in product launches
Previous experience working with alliance partners (i.e., co-promotions)
Strong leadership through participation in committees, job rotations, panels and related activities
TRAVEL:
Willingness/Ability to travel up to 30% - 40% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner.
The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $117,000 - $137,000 and eligibility for a sales incentive target of $39,000. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our career site. Applications accepted on an ongoing basis.
Why Lundbeck
Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.
Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site.
Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.
$117k-137k yearly 1d ago
Validation Specialist
IPS-Integrated Project Services 4.3
Indianapolis, IN job
Performs cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS' clients. Follows IPS and client standards and requirements, overall good industry practices for C/Q/V services and regulatory requirements. May also perform standalone commissioning services for non-FDA regulated clients.
Key Activities And Responsibilities
Write C/Q/V documents following established standards and templates, including but not limited to the following:
Commissioning Forms
C/Q/V Protocols and Summary Reports
Standard Operating Procedures
Impact Assessments
Specifications (URS/FRS/DDS)
FATS/SATs
Perform field/site activities including, but not limited to, the following:
Attend and witness FATs and SATs as a representative of IPS clients.
Execution of commissioning forms and witnessing of vendor start-up and testing.
Execution of C/Q/V protocols.
Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc.
Assist in deviation investigation and resolution of problems and issues encountered during field execution activities.
Work with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required.
Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
Read, understand and utilize the IPS Best Practices and SOPs for delivery of compliance services
Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management, of project status and issues, as requested.
Other duties as assigned.
Qualifications & Requirements
REQUIRED EDUCATION/QUALIFICATIONS /WORK EXPERIENCE
Associates or bachelor's degree in related field preferred.
Entry level position. 0 to 2 years of relevant experience.
Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA. Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software a plus.
General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA helpful.
CONTEXT AND ENVIRONMENT AND SAFETY
This position will have up to 100% travel to site, or as required by the assigned project.
Position may be assigned to client site for an extended period of time.
Overnight travel or staying in the city of Client's location is possible depending on assignment.
Travel will be per the IPS Travel Policy, client specific travel policy or project specific travel plan.
Position will visit Client sites and will be required to adhere to stated safety rules.
Position may visit active construction sites and will be required to take site safety training and adhere to site safety rules.
This position is a safety sensitive position.
The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research or other "non-administrative" areas.
DEMONSTRATED COMPETENCIES
Proficiency with Microsoft Office applications (Word, Excel, Project, Powerpoint, etc).
Personal skills and traits include:
Sense of urgency
Team player
Able to multi-task
Effective time management
Able to effectively prioritize
Good interpersonal skills
Attention to detail
Excellent customer service skills
Leads by example.
Deems the respect of upper management, peers and subordinates.
Empowers staff to succeed.
Supports and deploys technical training programs that assure competency and advancement levels to support corporate goals.
Promotes a friendly and efficient work environment, which rewards achievement and recognizes teamwork and champion's technical advancement, which supports our corporate goals. Maintain professional conduct and deliver services in a professional and acceptable fashion.
Works in conjunction with department management in recruiting new staff members and promoting IPS to potential hires (focused on cleaning and process validation).
Core Value Candidate Qualifications
Must exhibit an entrepreneurial spirit by consistently seeking new opportunities to add value to the organization.
Must strive for excellence in all aspects of job performance. Must approach their work enthusiastically with a contagious energy and drive that shows everyone they love what they do.
Must display creativity and innovation by continually working to improve solutions, tools, methods and service delivery system.
Must conduct oneself with an uncompromising commitment to the welfare of our clients and each other.
Must act in an ethical, professional and respectful manner at all times.
Must exhibit the ability to build and sustain long term relationships of mutual value through teamwork.
Must be driven to succeed and committed to goal attainment.
All interviews are conducted either in person or virtually, with video required.
About Us
IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do.
Specialties
Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services.
All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.
Connect With Us!
If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
$52k-68k yearly est. 3d ago
Fulfillment Lead, Pharmacy
Knipper 4.5
Charlestown, IN job
YOUR PASSION, ACTIONS & FOCUS is our Strength
Become one of our Contributors
Join the KnipperHEALTH Team!
The Fulfillment Lead, Pharmacy, would have the responsibility to monitor team activity and effectiveness, manage workflow on the fulfillment floor as unexpected increases/decreases in volumes dictate, assist in managing inventory, handle escalations, incident reporting, expedite tickets issued by the teams and assist in the setup of new initiatives and program launches for KnippeRx.
Responsibilities
KEY AREAS OF RESPONSIBILITY:
Demonstrate proficiency at all pharmacy technician activities in the fulfillment area.
Participate in training, daily monitoring, coaching and communication to team members.
Motivate and encourage contributors through positive communication and feedback.
Maintain a safe distribution/production environment.
Responsible for performing in-process inspections to ensure order accuracy on packing lines.
Ensure equipment is utilized as intended by the manufacturer with all guards and safety devices in place.
Assist and provide guidance to staff for handling fulfillment and shipping order escalations.
Provide administrative support to the pharmacists and/or support staff relative to department.
Ensure all cold chain inventory is stored upon receipt, with verification of receipt and counts completed.
Troubleshoot problems until resolved, escalating when needed and providing continuous communication of obstacles or needs related to fulfillment.
Ensure compliance with applicable regulations, KnippeRx Standard Operating Procedures, OSHA, Boards of Pharmacy, and industry best practices.
Accurately report on the consumption of resources (labor, materials, inventory, equipment, postage, etc.…)
Participate in all training and process improvement initiatives.
Responsible for appropriate escalation of any incidents related to inventory or quality.
Obtain proficiency with pharmacy management and shipping software processes and functions.
Effective written and oral communication across multiple departments.
The above duties are meant to be representative of the position and not all-inclusive.
Qualifications
REQUIRED EDUCATION AND EXPERIENCE:
High School Diploma
Pharmacy Technician license from the State of Indiana is required.
At least 2 years' experience in a high-volume pharmacy setting
Prior experience in training, lead roles, or supervisory experience is highly desirable.
Experience with HIPAA, PDMA, cGMP adverse events preferred.
Ability to read, write, speak, and understand the English language.
KNOWLEDGE, SKILLS & ABILITIES:
Excellent written and verbal communication skills.
Excellent analytical, problem solving and decision-making skills.
Ability to accept changing workflows and unexpected demands requiring flexibility.
Ability to work under pressure and appropriately prioritize responsibilities.
Ability to work independently with minimal supervision.
Ability to develop collaborative working relationships.
Ability to prepare and write investigational reports for management review.
Working knowledge of current including Good Documentation Practices, and Good Distribution Practices.
Thorough understanding of the State of Indiana Board of Pharmacy Regulations.
Ability to manage data in spreadsheets, give effective feedback, utilize project management techniques.
Able to use Microsoft Excel and Word at the following levels:
Basic Level: This level of skills is sufficient to perform daily word processing tasks, such as, producing routine letters, memorandums, and informal reports. A person with this level of skills can use basic formatting, editing, printing functions, and understands the document page setup.
Proficient in use of computers and ability to learn internal software programs.
Ability to use a calculator to perform basic math functions and understands the concept of same including: add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals; compute ratio, rate and percent.
Able to control one's own time and that of their direct reports; seeks agreement on resource allocation taking into account all stake holders; demonstrates frugality by properly preparing and adhering to budgets; seeks ways to decrease cost and/or create efficiencies.
PHYSICAL REQUIREMENTS:
Location of job activities 100% inside
Noise and/or vibrations exposure
Stand and sit for prolonged periods of time.
Occasional bending or stooping
Frequently required to reach with hands and arms.
Frequently lift and/or move objects up to 25 pounds.
Occasionally lift and/or move objects up to 35 pounds.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
$34k-45k yearly est. Auto-Apply 47d ago
Scientific Director - Sustainable Peptide Process Chemistry - SMDD
Eli Lilly and Company 4.6
Indianapolis, IN 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.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Summary:
Help shape the future of sustainable peptide development and bring life-changing incretin therapies to patients around the world! An exciting opportunity is available for a highly skilled and experienced scientist with expertise in peptide process chemistry to join the Synthetic Molecule Design and Development (SMDD) division at Eli Lilly and Company. You will be part of a dynamic, cross-functional department focused on sustainable synthetic peptide development and commercialization. In this role, you'll lead a variety of peptide commercialization projects, collaborate with global partners, and help advance next-generation, sustainable approaches to peptide manufacturing. This includes process development for Mounjaro and the commercial process development of multiple incretin peptide candidates progressing toward market launch.
Lilly is a global leader in incretin-based therapies, with a rapidly expanding portfolio that is transforming the treatment of diabetes, obesity, and related metabolic diseases. By joining this team, you will play a key role in shaping the future of this industry-leading pipeline and enabling access to breakthrough peptide medicines worldwide. We're looking for an innovative and energetic peptide chemist with a strong leadership background and deep industry knowledge. You'll work closely with a growing team of chemists, analysts, and engineers to design efficient synthetic routes and optimize commercial processes - helping to deliver the next generation of peptide therapies to patients around the world.
Responsibilities:
Lead a team of peptide chemists in designing and developing sustainable synthetic peptide processes.
Provide oversight for multi-kg scale peptide process development at contract manufacturing organizations (CMOs) and lead internal development activities.
Educate and mentor CMOs on best practices for greener peptide development and manufacturing.
Present research findings at internal forums and external conferences; publish in high-quality, peer-reviewed journals.
Communicate both the technical and business implications of research outcomes clearly and effectively.
Apply expertise in Tag-Assisted Liquid-Phase Peptide Chemistry to enable scalable and efficient peptide synthesis.
Top Candidates Will:
Demonstrate excellence in multiple modes of peptide synthesis, including hybrid SPPS/LPPS chemistry.
Have experience leading teams of scientists in peptide route development.
Enable the design, development, and implementation of sustainable, innovative processes for complex peptide synthesis, with a focus on PFAS-free conditions.
Implement green chemistry and engineering solutions to improve the environmental footprint of peptide manufacturing and reduce Process Mass Intensity (PMI).
Possess familiarity with chromatography, mass spectrometry, optical spectroscopy, and peptide automation.
Exhibit strong technical problem-solving ability and an intrinsic motivation to succeed in team environments.
Have a track record of innovative scientific research, demonstrated by publications in high-quality, peer-reviewed journals and presentations at external conferences.
Basic Qualifications:
Ph.D. in Chemistry or related field with 7+ years of pharmaceutical industry experience, or
B.S./M.S. in Chemistry with 12+ years of relevant experience in industry or academia.
Additional Preferences:
Strong interpersonal skills and a sustained track record of collaboration.
Ability to learn and apply new technical knowledge to meet evolving project needs.
Demonstrated flexibility, prioritization skills, and the ability to work effectively in dynamic environments.
Proven leadership capabilities, especially in cross-functional or global team settings.
Ability to balance multiple priorities and navigate ambiguity effectively.
Additional Information:
Physical Demands/Travel:
The physical demands of this job are consistent with a lab and office environment. Travel: 0-10%
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Work Environment:
This position's work environment is in a laboratory and office environment.
The
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representative of those an employee encounters while performing the essential functions of this job.
*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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
$148,500 - $257,400
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
$148.5k-257.4k yearly Auto-Apply 60d ago
Advisor - Quality Audit and Compliance (Controlled Substances)
Eli Lilly and Company 4.6
Indianapolis, IN 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 Advisor - Quality Audit and Compliance is part of the Global Quality Auditing and Compliance (GQAAC) division, which serves as the corporate quality auditing interface for global GxP compliance. This role focuses on Lilly‑designated Special Security Substances (SSS) and Controlled Substances (CS), ensuring processes meet company requirements, regulations, and guidelines. The Advisor provides regulatory interpretation and guidance across the product lifecycle-from discovery and development through launch, commercialization, and licensing-for all SSS and CS materials, including API, drug product, finished product, samples, and reference standards. Responsibilities include reviewing proposed CS regulations (particularly US DEA), collaborating with legal and industry groups on comments, owning and maintaining Lilly Quality Standard 303, and handling the risk assessment process for SSS designation.The Advisor - Quality Audit and Compliance (Controlled Substances) also assures quality assurance through the execution of internal and external audits in support of pharmaceutical development and commercialization for Lilly. Through auditing, the GQAAC auditor assures that GxP operations conducted or sponsored by Lilly are performed in accordance with company standards, policies, procedures, and practices and are compliant with current regulatory requirements and expectations, applicable guidelines, and industry standards. GQAAC operates as a valued business partner by taking a proactive approach to further improving the quality status of business operations and regulatory compliance. The quality auditor plays a key part in contributing to the implementation of this strategic approach to quality auditing oversight. Key Objectives/Deliverables:The following activities will be performed according to current GQAAC procedures, guidelines and tools. These responsibilities are not intended to be all-inclusive:Global SSS/CD Process Owner
Lead or participate in the preparation and review of standards, policies, procedures, and guidelines that define Quality, SSS, and CS requirements.
Build and maintain relationships with regulatory authorities; facilitate and host inspections from the US DEA, Indiana Board of Pharmacy, and other state CS agencies as required.
Maintain Power of Attorney documentation to manage DEA registrations, sign DEA Form 222, and complete required online reporting via the DEA website.
Interpret regulatory and quality standard requirements for business processes and provide guidance in response to related inquiries.
Develop or support corrective and preventive actions (CAPAs) to address gaps in SSS/CS compliance processes.
Escalate compliance issues promptly and appropriately.
Ensure adherence to applicable quality standards, manuals, policies, procedures, and tools.
Auditing Responsibilities
Interpret and apply Lilly standards, regulations, regulatory guidance, industry standards, to identify compliance risks and maintain a comprehensive knowledge of applicable regulations, technical knowledge, and training to meet the auditing responsibilities.
Lead or participate in planning, scheduling, preparing, conducting, appropriately escalating compliance issues, and reporting audits, assessments, and due diligences of GMP Operations and SSS/CD to assess the level of compliance with established standards and current regulations and guidelines.
Lead or participate in risk assessments and mock regulatory inspections of GMP Operations and SSS/CD to assess level of compliance and/or readiness to meet established standards and current regulations and guidelines, as applicable.
Provide technical input and recommendations to audit observation reports during the Audit Review Board meeting, as applicable.
Exhibit ethical behavior when auditing, including integrity, objectivity, and confidentiality, including the competency to recluse oneself from an audit when a conflict of interest or lack of competency in a specific area exists.
Exhibit interpersonal skills that are relevant to auditing, such as listening, questioning, being tactful and having appropriate non-verbal skills, handling conflict in a constructive manner and communicating (both written and verbal) in a clear and concise manner.
Exhibit skills relevant to auditing, such as evaluating and judging, drawing conclusions, understanding technical material and data integrity concepts, business understanding, identifying problem areas, knowledge of audit principles, and ability to manage time.
Business-related Responsibilities
Lead or participate in the continuous improvement of the GQAAC quality system and other GQAAC organizational priorities.
Participate in the continuous improvement of the global quality system and other corporate priorities, as requested.
Establish and maintain relationships with the relevant business units, including providing audit-related advice, interpretation of Lilly global quality standards and regulations, and inspection readiness assistance.
Participate and/or support GQAAC self-assessments or regulatory inspections.
Personnel Development Responsibilities
Complete required training and qualifications as identified in your Learning Plan.
Remain current of regulatory and industry trends, including regulatory agency interpretation of requirements.
Serve as a mentor and coach for others within the GQAAC organization.
Attending training courses, conferences, or association meetings to continue to gain knowledge and to share such information with other members of the group or company to increase their awareness, as assigned.
Basic Qualifications/Requirements:
Minimum of five (5) years' experience related to the pharmaceutical industry.
Bachelor's degree in Science or Engineering
Additional Skills/Preferences:
Ability to work safely to ensure self-safety and the safety of others.
Strong working knowledge of global regulations and guidelines (e.g., DEA, FDA, EU, and industry standards (e.g., ICH, ISPE, PIC/s) for CS and GMP operations) and the ability to interpret and apply regulatory and guidelines to the pharmaceutical industry.
Prior auditing experience, including auditor certification by an external body (e.g., ASQ Quality Auditing).
Capacity to produce high quality results across multiple projects and demands, through effective prioritization, while working under short deadlines associated with a fast-paced dynamic scientific environment.
Ability to deliver timely and professional communications (oral and written) with precision and clarity to all levels of the organization.
Excellent personal skills, including motivation, self-management, commitment, and the ability to work well with others.
Excellent teamwork skills, including being open-minded and flexible to adopting new ideas.
Strong project management skills to manage projects at various stages and effectively multi-task.
Ability to maintain a flexible work schedule and adapt quickly to accommodate audit program priorities and other business-related priorities.
Working knowledge of Microsoft office 365 suite and other business programs (e.g., document management systems, quality management systems).
Additional Information:Domestic and international travel is required to fulfill these job responsibilities. Must be able to travel up to 50%, sometimes on short notice.
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
$115,500 - $184,800
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
$115.5k-184.8k yearly Auto-Apply 60d+ ago
Life Safety Systems Rep III, Electronic
Johnson Controls Holding Company, Inc. 4.4
Indianapolis, IN job
What you will do
The primary function of this position is to promote and sell the Johnson Controls value proposition into the new Construction market via electrical/general contractors and consulting engineers, as well as providing Fire and Life Safety solutions to their projects and execution needs.
How you will do it
Manage the entire sales process from uncovering opportunities, developing solutions/value proposition, preparing design, creating contracts, negotiating terms, closing opportunities and providing on-going customer service through service delivery.
Must be able to establish contact with prospects and qualify potential buyers by scheduling face to face sales calls, following up on leads and utilizing Johnson Controls marketing strategies; to determine customer needs and develop a sales strategy to gain customer understanding of company product offerings.
Develop a sales plan for assigned territory to include segmenting territory based on customer type; to qualify and prioritize opportunities and to maintain appropriate territory records; expectations to update and maintain an accurate sales pipeline with sufficient opportunities to achieve monthly/quarterly/annual quota targets; Sales pipeline will be used to generate the individual seller's forecasted opportunities each month.
Must be able to allocate time effectively with the goal of meeting or exceeding quote requirements; conduct seminars, demonstrations, etc. in order to generate, develop and qualify leads for prospective customers; to develop financial justifications, prepare proposals, make presentations and perform necessary follow-up for successful closing of the sale.
Must maintain established accounts through regular customer contact in pursuit of follow on sales; participate in trade shows, special product demonstrations and other events with the objective of increasing sales and enhancing the company's image.
What we look for
Required:
Minimum of 3 years successful sales experience selling in the building construction industry.
Experience working with electrical contractors, ability to read blueprints and wiring diagrams is desirable.
Exposure to computer/ applications software a plus. Must possess good oral and written communication skills and sales techniques, solid presentation skills and closing techniques.
Must have the ability to persuade and close sales. Must be a self-motivator with good organizational skills.
Preferred:
Knowledge of Fire Alarm Systems or Security Systems
Computer Literate - Windows Applications
Valid Driver's License
Sales Experience
High School Diploma or Equivalent
HIRING SALARY RANGE: $60K-$80K annual base salary + commissions (Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, location and alignment with market data.) This role also offers a competitive Sales Incentive Plan that will take into account project, quarterly, and annual margin. This position includes a competitive benefits package. For details, please visit the About Us tab on the Johnson Controls Careers site at *****************************************
Johnson Controls International plc. is an equal employment opportunity and affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, genetic information, sexual orientation, gender identity, status as a qualified individual with a disability or any other characteristic protected by law. To view more information about your equal opportunity and non-discrimination rights as a candidate, visit EEO is the Law. If you are an individual with a disability and you require an accommodation during the application process, please visit here.
$60k-80k yearly Auto-Apply 21d ago
Veterinary Assistant
Alliance Animal Health 4.3
Indianapolis, IN job
Rockville Road Animal Hospital is a well-established, progressive, fast paced 2 doctor small animal general practice with lots of growth potential located just 5 minutes away from I-465, the beltway circling Indianapolis. We offer many services to provide the best comprehensive care to our patients including Preventative Care, Surgery, Urgent Care, High Speed Dentistry, Cold Laser Therapy, In-House Diagnostics, Digital full-body x-ray, and dental radiology, and more.
Rockville Road Animal Hospital is in Indianapolis, known for being one of the most affordable big cities in the country offering a diverse population, ample indoor and outdoor entertainment options, and sports including the NBA, NFL, Indy Car racing and more! The proximity to I-465 and several other major highways, allows for easy commute to almost anywhere inIndiana. Whether you choose to live in downtown Indy or one of the surrounding suburbs you will find outstanding schools and plenty to do, making it an ideal place to raise a family! Popular activities include hiking, biking, concerts and festivals, sporting events including the Indianapolis 500, visiting museums (including the world's largest Children's Museum), and the theater. Indianapolis is a wonderful place to enjoy a healthy and active work-life balance.
To learn more about us click here.
Job Description
Job duties include, but are not limited to:
Pet restraint, triage incoming patients, collection and analysis of lab samples, diagnostic imaging, management and nursing care of medical and hospitalized cases with varying degrees of stability, administration of medications, effective communication of treatment plans with clients, surgical preparation and assistance, and anesthetic management.
Must be able to withstand unpleasant odors and noises. May be exposed to bites, scratches, animal waste and potentially contagious diseases.
Whether you're looking to just be a master of your role or trying to grow into that next career move, you'll have opportunities through a variety of virtual and hands on, interactive training and continuing development.
Qualifications
We're looking for:
* An experienced Veterinary Assistant with a minimum of 1+ years experience required
* Anesthesia experience preferred
* Compassionate, Calm, Team Player, Multi-Tasker and Strong Communicator
* Must be able to properly restrain pets.
* Proficient in sample collection, obtaining medical histories, processing laboratory tests and radiographs, and anesthesia monitoring are a bonus!
* Self-starter with the desire to continue to advance your knowledge and skillset.
Additional Information
Job type: Full-Time
We offer our staff:
* Comprehensive Benefits (health, dental, vision, liability, 401k & 401K matching program, life & supplemental insurance, HSA, & FSA)
* Employee Assistance Program
* Paid Vacation and Sick Time for ALL Employees
* Paid Bereavement Program
* Paid Parental Leave Program
* Competitive Compensation
* Continuing Education Allowance (applies to licensed/registered/certified roles)
* Tuition Assistance Program
* Access to a CVA/CVT/CVPM Partnership through Penn Foster
* Career Development Opportunities
* Referral Bonus Program for most positions!
* Additional Benefits May Also Be Available (i.e. Personal Pet Discounts, Holiday Pay, Uniform Allowance, Bonuses etc)
* *Hiring eligibility may be contingent to a candidate authorizing and completing a satisfactory background check.
* Note - some benefits may only be available to or vary slightly for full time employment status vs part time status.
For additional details including our full equal opportunity statement, texting/outreach communication authorization, physical requirements of the job and more, please visit ************************************************************
#SS2
$25k-31k yearly est. 3d ago
Advisor - Technical Services
Eli Lilly and Company 4.6
Indianapolis, IN 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.
Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Summary:
This position is part of the Bioproduct Research and Development (BR&D) organization within Lilly Research Labs. The BRD Clinical Trial (CT) manufacturing facility is focused on bringing new protein therapeutics to market by producing bulk drug substance (DS) for clinical trials, along with the associated technical data and documentation to support GMP activities.
The Bioprocess Operations team within BR&D is responsible for the manufacture of DS to support clinical trials within the Lilly portfolio. This includes the internal manufacture of monoclonal antibodies, bioconjugates, and adeno-associated viruses, as well as oversight of DS manufacturing at qualified collaboration partners. This role serves as the Technical Lead for the Downstream Tech Service and Manufacturing Science (TS/MS) team within the BR&D DS CT manufacturing facility. You will combine technical leadership with strategic execution-driving DS batch technology transfer and delivery, ensuring robust clinical manufacturing performance, and acting as a key technical interface across development, operations, automation, and maintenance teams. In addition, you will mentor and develop downstream team members, fostering a culture of technical excellence and continuous improvement.
Responsibilities:
In this role, you will provide oversight of downstream processes for Bulk DS production and lead initiatives that enhance plant performance and reliability. You will partner closely with cross-functional teams to resolve complex technical challenges, implement innovative solutions, and ensure seamless integration of development-stage technologies into clinical manufacturing. Your leadership will extend beyond technical execution to include coaching and developing talent within the team. Responsibilities will include:
Lead and deliver downstream process technology transfer for Bulk DS into clinical manufacturing
Input and authoring for cGMP and PRD Quality System compliant manufacturing master production records and review of executed batch records where applicable
Ensure robust execution of DS batches with adherence to quality and regulatory standards
Active oversight of process and equipment performance, troubleshooting, optimization and real-time data monitoring
Serve as primary technical resource for downstream operations in the DS CT manufacturing pilot plant
Drive alignment between process development and manufacturing execution
Lead plant improvement projects focused on safety, efficiency, reliability, plant digitalization, and scalability of downstream operations
Actively engage with HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Engineering, Maintenance, Environmental Monitoring, and Manufacturing to resolve complex technical challenges.
Coach and mentor team, fostering technical growth and professional development
Promote a culture of collaboration, accountability, and operational excellence
Basic Requirements:
PhD in Chemical Engineering, Chemistry, Biochemistry, Biology, or related discipline with at least 3 years hands-on purification experience OR
MS in Chemical Engineering, Chemistry, Biochemistry, Biology, or related discipline with at least 5 years hands-on purification experience OR
BS in Chemical Engineering, Chemistry, Biochemistry, Biology, or related discipline with at least 8 years hands-on purification experience
Proficiency with UNICORN software for chromatography process control and data analysis
Demonstrated ability to lead cross-functional projects and mentor technical staff
Excellent communication and leadership skills, with the ability to influence and drive change
Additional Preferences:
Understanding of cGMP requirements and regulatory compliance for clinical manufacturing
Experience with scale-up of biopharmaceutical purification operations
Familiarity with automation systems and process control strategies
Understanding of computer system validation and equipment qualification
Familiarity and strong interest in application of digital solutions for GMP DS manufacturing
Additional Information:
Position located in Indianapolis, IN at the Lilly Technology Center North
8-hour days with flexibility to support activities during shutdowns, weekends, and outside of core hours
Physical Demands/Travel:
The physical demands of this job are consistent with an office and manufacturing environment.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Work Environment:
This position's work environment is in the office and manufacturing environment.
The
work
environment
characteristics
described
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representative of those an employee encounters while performing the essential functions of this job.
*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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
$129,000 - $209,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$129k-209k yearly Auto-Apply 32d ago
Lab Asset Management Senior Metrologist
Eurofins Us Network 4.4
Indianapolis, IN job
Indianapolis, IN, USA Full-time ** _The work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package._
_Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies._
_If you're looking for a rewarding career, a place to call home, apply with us today! _
**Job Description**
**Job Summary:**
Support laboratory instrumentation through qualification, maintenance, troubleshooting, and data management in a GMP-regulated environment.
**Key Responsibilities:**
+ **Instrument Qualification & Maintenance:** Perform and document qualifications for lab instruments (e.g., HPLC, GC, KF, UV-Vis).Execute scheduled and post-maintenance qualifications and verify system readiness for open-access instruments.
+ **Repairs & Troubleshooting:** Conduct urgent repairs on user-accessible components (e.g., lamps, pumps, seals, tubing).Troubleshoot routine calibration-related issues and assist with instrument upgrades.
+ **Software & Data Management:** Utilize chromatography data software (e.g., Empower) and input data into GMARS asset management system.Maintain accurate instrument files, including work orders and qualification records.
+ **Vendor & Client Coordination:** Escort vendors for on-site maintenance and coordinate service activities.Interface with clients and project teams to support asset and data management functions.
+ **Reporting & Metrics:** Document service activities and report on instrument performance metrics.
**Qualifications**
+ **Education & Experience:** Bachelor's degree in life sciences (e.g., chemistry, biology) with 4+ years of relevant industry experience, or MS/PhD in life sciences with 2+ years of relevant pharmaceutical industry experience.Experience in a GMP space. Experience with audits is highly beneficial. Experience with change controls preferred.
+ **Technical Skills:** Strong computer, scientific, and organizational skills.Proficiency in Microsoft Office and ability to learn new lab techniques.
+ **Communication & Collaboration:** Excellent written and verbal communication skills.Ability to work independently and collaboratively with internal and external teams.Ability to assist vendors and clients in solving issues.
+ **Work Style & Compliance:** Detail-oriented, self-motivated, adaptable, and capable of multitasking.Skilled in maintaining accurate records and following company policies.
**Additional Information**
+ Position is full-time, 8:00 am- 5:00 pm Overtime as needed.
+ Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
+ Life and disability insurance
+ 401(k) with company match
+ Paid vacation and holidays
+ _\#LI-EB1_
**Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.**
$69k-99k yearly est. 13d ago
Chemist - Industrial Hygiene Lab
Eli Lilly and Company 4.6
Indianapolis, IN 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:
The Lilly Industrial Hygiene (IH) Lab provides trace analytical services for the company's global Industrial Hygiene (IH) community. A primary mission of the IH Lab is to develop and validate monitoring methods for active pharmaceutical ingredients (APIs) coming from the clinical development pipeline. Lab staff work closely with site/location Industrial Hygienists to provide routine analysis of samples taken in the development and manufacturing space in support of employee exposure assessment, and they coordinate all 3rd party analytical needs including external data review and release. As well, lab staff provide creative technical solutions and project support for emerging needs as identified by the global IH community. This position reports through the Global Health, Safety, and Environment organization.
Responsibilities:
A primary mission of the IH Lab is to develop and validate monitoring methods for active pharmaceutical ingredients (APIs) coming from the clinical development pipeline. Monitoring methods typically include air sampling methods for personnel exposure characterization and swab methods for cleaning effectiveness after spills and decommissioning but may also include air and water monitoring methods and sample analysis for environmental evaluations. Key responsibilities of this position include:
Partnering with internal customers and external lab vendors to efficiently meet business needs.
Developing and validating air and surface monitoring methods, including sampling media. This may involve internal/external research and troubleshooting until an acceptable recovery is achieved.
Conduct laboratory analysis of active pharmaceutical ingredient (API) samples collected globally.
Coordinating sample analysis with third party laboratories and conducting a review of results before releasing to internal customers.
Calculating, documenting, and reporting study results via established laboratory programs such as electronic notebooks and laboratory software application.
Routinely monitoring the clinical development pipeline, connecting with site Industrial Hygienists to prioritize method development needs, and initiating requests when an occupational guideline limit is needed.
Peer reviewing laboratory data to confirm it is accurate and in compliance with procedures, assuring data is stored as required for archival, and supporting laboratory data quality assessment.
Researching and supporting the solution of key technical, operational, or business problems, as needed.
Organizing and/or conducting laboratory inspections and supporting the resolution of observations or areas for improvements.
Representing Lilly in the AIHA Pharma Round Robin and participating in external scientific forums, as appropriate.
Maintaining awareness of analytical sciences, pharmaceutical industry trends and industrial hygiene issues to drive continuous improvement in laboratory services.
Basic Requirements:
B.S. with > 5 years of relevant experience or M.S. with >3 years of relevant experience in chemistry, biochemistry, or closely related field of study
Mass spectrometry, liquid, and gas chromatography analytical method development experience.
Additional Skills/Preferences:
Proteomics experience strongly preferred.
Experience in ISO 17025 accredited laboratory.
Industrial Hygiene Chemist Certification.
Experience in GMP lab operations and Lean.
Coursework or experience in industrial hygiene or environmental sampling.
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
$65.3k-169.4k yearly Auto-Apply 24d ago
Director, Field Strategy & Operations (Everest)
Otsuka America Pharmaceutical Inc. 4.9
Indianapolis, IN job
**About Otsuka** We defy limitation, so that others can too. In going above and beyond-under any circumstances-for patients, families, providers, and for each other. It's this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.
**Position Overview:**
The Director of Field Strategy and Operations serves as the orchestrator of field strategy, ensuring that prioritization, stakeholder engagement, and execution are effectively aligned with brand strategy and enterprise objectives. This role provides leadership across multiple regions, enabling a holistic, enterprise-wide approach to field strategy and operational excellence.
This role also partners closely with the Business Analysis team to ensure field teams have access to standardized dashboards and data-driven insights, supporting execution excellence and performance tracking. The Director will be the point of contacts for ad hoc analytics requests, ensuring field teams have the right data to make informed decisions, but will not be creating these reports themselves or with their team and will work with Business Analysis to ensure accurate measurement and proper data is used.
**Key Responsibilities:**
+ **Strategic Prioritization & Field Execution:** Align field activities with marketing strategy, launch planning, and market access pull-through, ensuring execution efficiency.
+ **Execution Excellence & Field Performance Tracking:** Oversee Omnichannel efforts, account planning, and KPI tracking, ensuring insights from Field Analytics support execution.
+ **Strategic prioritization & orchestrating field execution: Analyzes current and future state of the business based on insights and trends, and** leads efforts to align field activities with high-priority initiatives such as marketing strategy, launch planning, and market access pull-through.
+ **Field Communication & Data-Driven Decision Support:** Act as the primary field communicator, ensuring clarity on CRM tools, performance insights, and operational priorities.
+ **Resource Allocation & Budget Optimization:** Optimize the distribution of budgets, speaker programs, and promotional resources, leveraging data-driven insights to maximize ROI.
+ **Team Development & Analytics Training:** Mentor team members on business reviews, reporting systems, and analytics interpretation, working with Business Analysis to enhance field intelligence capabilities.
+ **Compliance Management:** Must comply with all state and federal laws, regulations and guidelines including PhRMA Code on Interactions with Healthcare Professionals as well as complying with all OAPI standards and policies relating to all job activities.
**Qualifications:**
+ Bachelor's degree required; MBA or advanced degree preferred.
+ Minimum of 10 years of pharmaceutical experience, with a strong understanding of sales force operations and execution.
+ Prior experience in field leadership roles such as first- or second-line leadership, regional operational and customer strategy roles or other field-based support roles required.
+ Established expertise in business analytics, business operations, sales support, and resource management within a commercial pharmaceutical organization.
+ Ability to focus on priorities and resolve operational issues effectively.
+ Excellent communication and collaboration skills, with the ability to work cross-functionally and drive execution efficiency.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $194,247.00 - Maximum $290,375.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
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Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
$49k-73k yearly est. 60d+ ago
Women's Health Business Specialist - Fort Wayne North, IN
Astellas Pharma 4.9
Fort Wayne, IN job
Developing innovative therapies is one of the most challenging, most essential, and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Women's Health Business Specialist opportunity in the **Fort Wayne North, IN** area.
**The Role**
Achieve territory sales goals by promoting Astellas products and services to physicians and other medical personnel within assigned geography. Educate customers on the use, characteristics, advantages, indicated treatments and all other developments related to promoted products. Professionally represent Astellas in the field and ensure high levels of visibility and customer satisfaction in territory. Maintain effective communication and relationships with key external and internal customers.
Flexible grade level based on candidate background and skillset.
**Primary Responsibilities**
+ Effectively promote and educate targeted physicians/HCPs on the use of Astellas' products through one-on-one meetings and group presentations, company-approved promotional speaker programs, and other company-approved means.
+ Work 5 days in the field each week, supported by office time as needed for call planning, customer follow-up, preparing presentations, making appointments, report generation, etc.
+ Ensure solid performance levels of call and field productivity. Meet Call Plan expectations and achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations
+ Execute company-approved Product Marketing plans and territory/regional business plan activities
+ Support targeted customers using company-approved resources, sales materials, and promotional activities/programs/initiatives as identified by Sales Management
+ Coordinate promotional efforts with peers across franchises and co-promotion alliance partners as appropriate. This includes appropriately managing/maintaining all company equipment and company-approved promotional materials (e.g., sales materials, company literature, product samples, etc.) according to defined company Compliance guidelines
+ Achieve territory product sales goals while adhering to all APUS-defined ethical sales practices, Compliance guidelines, and required promotional regulations
+ Ensure territory sales strategy execution using annual territory business plan, regional business plan, and call activity reports
+ Accurately report/submit sales call activities, territory expenses and written reports and within deadline as defined by Astellas or the Regional Sales Manager
+ Attend all company-sponsored sales and medical meetings as directed by company management.
+ Additional duties as needed
**Quantitative Dimensions**
+ This position is responsible for achieving both territory product sales goals and territory sales activity goals through company defined metrics
**Organizational Context**
It is important for individuals in this position to actively pursue continuous learning and professional sales development on effective sales and communication techniques and product/therapeutic area knowledge.
This position:
+ Is a customer facing sales position
+ Reports to Regional Sales manager
+ Maintains territory responsible for managing Astellas' products
+ Partners with counterparts, teammates, and cross functional colleagues as appropriate
+ Balance's territory and regional work and projects, while maintaining solid level of sales performance
+ Exhibits strong level of skill in competencies
+ Demonstrates sales influence within territory and at times within region
**Qualifications**
**Required**
+ BA/BS degree
+ 2+ years pharmaceutical selling experience
+ Strong knowledge of sales processes and pharmaceutical products and industry
+ Solid communication, facilitation, and presentation skills
+ Proactive; can do approach
+ Demonstrates problem solving ability; analytical; business acumen
+ Solid motivational and persuasion skills
+ Demonstrates team orientation and leadership
+ Proven record of sustained high sales performance and achievement
+ Proficient in MS Office Suite
+ Ability to travel at least up to 50% of the time; and at times overnight travel
+ Valid driver's license in good standing
**Preferred**
+ Advanced degree or continued education
+ Knowledge of promoting specialty products
**Salary Range:** $72,485 - $141,900 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)
**Benefits:**
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Company-paid fleet vehicle for eligible positions
+ Referral bonus program
This is intended to describe the general nature and level of work which may be performed by the person assigned to this position. This job description is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of this position.
Employees holding this position may perform other job-related duties in the course of their performance of this position.
**\#LI-LK**
_All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._
Category Sales
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
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 currently constructing a cutting edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly's most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply.
This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The TS/MS team will own all areas of technology transfer, process validation, and process stewardship.
Position Description:
Bioprocess - Technical Services/Manufacturing Scientist (TS/MS) role is responsible for providing technical support for the development, implementation, and technical transfer of compliant manufacturing of gene therapy drug substance for clinical and commercial manufacture. The successful candidate will be required to build deep technical expertise in their area of responsibility (including in-depth knowledge of the science behind the molecule and the process), have strong working skills on the manufacturing equipment set and control systems, and consistently demonstrate strong data-driven decision-making and problem-solving capabilities. They may also work to ensure that the process is in-control, capable, compliant, and maintained in a validated state through continual monitoring and may play a role in by implementing new technologies and process improvements in the manufacturing environment.
Key Objectives/Deliverables
Have an in-depth knowledge of the science behind the molecule and the processes. Understand the process control strategy for gene therapy products
Provide technical support for all start-up TS/MS activities (e.g., NPI, tech transfer, process validation, process stewardship and improvement)
Ownership and technical stewardship of bioprocess and provide technical expertise during Root Cause Analysis for deviations and Impact Assessments for changes
Work as part of cross-functional teams, and establish partnerships with applicable functions, operations, and development to understand interface between the science/engineering with the operations on the floor and bring deep technical expertise to the team
Be able to assess whether the process is in control and capable of meeting its stated purpose and is in a constant state of validation
Identify process improvements and participate in implementation of Lean manufacturing initiatives
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, process description documents and annual reports
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
Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability
Serve as technical interface external to the Lebanon site
Provide audit support, as needed
Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives.
Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities
Basic Requirements:
Bachelor's in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry or related quantitative field
3+ years of experience in cGMP manufacturing, specifically within Operations, Validation, TS/MS, or Engineering
Additional Preferences:
Have an in-depth knowledge of the science behind the molecule and the processes on mRNA/LNP drug substance manufacturing. Understand the process control strategy for mRNA/LNP mediated gene therapy products
Experience and understanding of technical challenges with mRNA as a therapeutic modality is required
Experience with mRNA/LNP formulation
Experience with QC assays in line with product CQAs including variability
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
Experience with data trending and analysis
Ability to analyze complex data and solve problems
Demonstrated successful membership/leadership of cross-functional teams
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
$66k-171.6k yearly Auto-Apply 60d+ ago
Director - Clinical Research Scientist - Immunology/Gastroenterology Development
Eli Lilly and Company 4.6
Indianapolis, IN 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.
The GI Therapeutic Area within Lilly Immunology Development is focused on developing new therapies for patients with gastrointestinal diseases. The GI immunology development team is seeking a motivated clinical research scientist that is passionate about drug development within gastroenterology. The candidate must have extensive drug development experience in mid-to-late phase trials. They will engage in various trial related activities including but not limited to the development, conduct and reporting of global clinical trials in support of registration and commercialization of new therapies; the reporting of adverse events; the drafting and review process for protocols, study reports, publications; engagement with global regulatory authorities and other governmental agencies; outreach medical activities including thought leaders engagement.
Key Objectives/Deliverables
The primary responsibilities of the Development CRS are generally related to late-phase and marketed compounds. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned.
Clinical Planning: product lifecycle plan, clinical strategies, development plans and study protocol design. Provide subject matter expertise and keep updated with the pre-clinical and clinical data relevant to the molecule
Clinical Trial Execution and Support: Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions. Supports the monitoring of patient safety during study and engages in the global product safety reviews. Cross function collaboration with clinical trial teams in the design, conduct and reporting of mid to late phase clinical trials. Conduct study start-up meetings, investigator meetings and other activities to provide the appropriate training and information to investigators and site personnel.
Scientific Data Dissemination/Exchange: engage in reporting of clinical trial data in Clinical Trial Registry activities. Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Establish and maintain collaborations and relationships thought leaders. Support clinical trial data analysis and publications.
Regulatory Support Activities: Provide medical expertise to regulatory scientists and support regulatory strategy.
Scientific and Technical Expertise and continued development: Acts as scientific consultant and protocol expert for clinical study team members and others in medical.
Minimum Requirements
An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as, PharmD, PhD
3+ years of clinical development experience, including mid-to-late-stage development
Additional Skills/Preferences
Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills
Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills
Previous GI drug development experience
Pediatric drug development experience
Oral/written communication/listening skills are essential
Strong relationship-building and interaction skills with peers and management
Preferred location is Indianapolis, though remote arrangements may be considered
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
$177,000 - $338,800
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
$108k-148k yearly est. Auto-Apply 3d ago
Senior Research Director, Analytical Chemistry - Synthetic Molecule Design and Development
Eli Lilly and Company 4.6
Indianapolis, IN 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.
The Synthetic Molecule Design and Development (SMDD) organization is responsible for the development of synthetic drug substances and drug products from the pre-clinical phase through commercialization. Our scientists and engineers develop innovative technical solutions to advance an exciting portfolio that includes small molecules, synthetic peptides, oligonucleotides, and other emerging therapeutic modalities. By fostering a hardworking, culturally diverse workforce that exhibits deep technical expertise, SMDD delivers on these responsibilities and helps bring the next generation of life-changing medicines to patients.
Position Summary:
The Senior Research Director, Analytical Chemistry, will be responsible for the technical leadership and execution of analytical efforts for the commercial development of drug substance and/or drug product processes. Our team is seeking experienced, innovative, and motivated scientists to apply their strong foundation in analytical sciences and experience in synthetic process or formulated product development to enable clinical trials, regulatory submissions, and new product commercialization. This technical-track role offers the opportunity to lead the analytical effort within a multidisciplinary project team consisting of chemists, formulation scientists, and engineers while offering access to world-class capabilities for pharmaceutical development.
Responsibilities:
Drive implementation of technical solutions and analytical strategies to enable drug substance process or drug product formulation development.
Collaborate with project development teams, regulatory scientists, and manufacturing partners to deliver robust control strategies for drug substances, drug products, and/or drug product intermediates (e.g., spray-dried dispersions).
Apply prior experience authoring IND/CTA, NDA/MAA, and country-specific response to questions and/or registering products across global markets.
Provide technical guidance for analytical activities executed within the external network. Ensure methods are technically sound, well developed, and fit for purpose. Execute technology transfer to CRO/CMO organizations and Lilly manufacturing sites.
Demonstrate high learning agility and the ability to understand and exploit effective scientific concepts and methods across multiple subject areas (e.g., chemistry, pharmaceutical sciences, PAT, and modeling and simulation).
Mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing.
Plan and manage short-term and long-term development activities. Develop and/or review technical agendas and timelines for project work. Recommend resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction.
Collaborate closely with organizations across development and manufacturing to deliver material and information for clinical trials and regulatory submissions.
Welcome varied perspectives to create new solutions.
Actively engage in the external environment; recognize and apply external innovation across the Lilly synthetic portfolio.
Basic Requirements:
Ph.D. in analytical chemistry or bioanalytical chemistry, or a related field
8+ years' experience in a pharmaceutical industry setting with specific focus on small molecules, synthetic peptides, or oligonucleotides.
Demonstrated expertise leading analytical efforts in pharmaceutical product development and commercialization. Proven skills developing, validating, and transferring analytical methods, authoring regulatory documentation, and overseeing CMO/CRO activities.
Must possess strong communication (oral, written), organizational, and leadership skills.
Additional Preferences:
Experience with product commercialization, including technical transfer of analytical methods into manufacturing operations.
Demonstrated ability to drive and accept change.
Good interpersonal skills and a sustained tendency for collaboration.
Demonstrated success in persuasion, influence, and negotiation.
Additional Information:
Travel: 0 to 10%
Position Location: On-site, Indianapolis, IN; Lilly Technology Center-North (LTC-N)
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
$144,000 - $250,800
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
$144k-250.8k yearly Auto-Apply 47d ago
Sr. Director - Parenteral Technical Services Stewardship
Eli Lilly and Company 4.6
Indianapolis, IN 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.
Position Brand Description:
This position provides leadership for the Lilly Global Parenteral Technical Services/Manufacturing Science organization. It assures that appropriate qualified resources and systems are in place to provide technical stewardship of existing processes across all sites in the network, internal and external.
Key Objectives / Deliverables:
Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountably for supporting all HSE Corporate and Site Goals
Provide leadership to global molecule stewards supporting commercial products/technical projects
Serve as initial point of contact and escalation for technical issues
Performance management and development of staff, in partnership with Executive Director - Parenteral Technical Services and Associate Vice President - Parenteral Technical Services
Assure that appropriately trained and qualified staff are in place to provide network level stewardship and execution of the Parenteral Technical Agenda
Represent the Technical Services organization at the various governance bodies to be determined by Associate Vice President - Parenteral Technical Services
Serve as facilitator of Parenteral Technical Network meetings
Develop and utilize reward and recognition initiatives for staff
Build relationships and influence manufacturing sites
Minimum Requirements:
B.S. degree or higher in a science, engineering, or technical related field
15+ years of related pharmaceutical manufacturing experience/cGMP working environment
10+ years experience in parenteral manufacturing, specifically technical services-related roles
Prior experience in technical leadership roles
Additional Preferences:
Ability to prioritize efforts
Effective written and oral communication skills
Effective interpersonal skills
Ability to maintain a safe work environment, working safely and accountably in support of all HSE Corporate and Site goals
Other Information:
8-hour days Monday through Friday
Overtime will be required, as you will need to be available off-shift and respond to operational issues as needed
Some travel will be required (
This is NOT a remote position and on-site presence is 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
$151,500 - $222,200
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$151.5k-222.2k yearly Auto-Apply 4d ago
Veterinary Assistant
Alliance Animal Health 4.3
Franklin, IN job
Franklin Animal Clinic is a well-established, progressive, fast paced 6 doctor small animal practice located in Franklin, IN. We offer many services to provide the best comprehensive care to our patients including Wellness Services, Urgent Care, Emergency & Critical Care, General & Orthopedic Surgery, Digital Full Body and Dental X-Ray, Ultrasound, CT, Full In-House Idexx Laboratory, In-House Pharmacy, Cold Therapy Laser, Surgical Laser, 24-hr Nursing Care, Medical Boarding & more.
To learn more about us click here.
Job Description
Job duties include, but are not limited to:
Pet restraint, triage incoming patients, collection and analysis of lab samples, diagnostic imaging, management and nursing care of medical and hospitalized cases with varying degrees of stability, administration of medications, effective communication of treatment plans with clients, surgical preparation and assistance, and anesthetic management.
Must be able to withstand unpleasant odors and noises. May be exposed to bites, scratches, animal waste and potentially contagious diseases.
Whether you're looking to just be a master of your role or trying to grow into that next career move, you'll have opportunities through a variety of virtual and hands on, interactive training and continuing development.
Qualifications
We're looking for:
* An experienced Veterinary Assistant with a minimum of 1-year experience preferred.
* Compassionate, Calm, Team Player, Multi-Tasker and Strong Communicator
* Must be able to properly restrain pets.
* Proficient in sample collection, obtaining medical histories, processing laboratory tests and radiographs, and anesthesia monitoring are a bonus!
* Self-starter with the desire to continue to advance your knowledge and skillset.
Additional Information
We offer our staff:
* Comprehensive Benefits (health, dental, vision, liability, 401k & 401K matching program, life & supplemental insurance, HSA, & FSA)
* Employee Assistance Program
* Paid Vacation and Sick Time for ALL Employees
* Paid Bereavement Program
* Paid Parental Leave Program
* Competitive Compensation
* Continuing Education Allowance (applies to licensed/registered/certified roles)
* Tuition Assistance Program
* Access to a CVA/CVT/CVPM Partnership through Penn Foster
* Career Development Opportunities
* Referral Bonus Program for most positions!
* Additional Benefits May Also Be Available (i.e. Personal Pet Discounts, Holiday Pay, Uniform Allowance, Bonuses etc.)
Hiring eligibility may be contingent to a candidate authorizing and completing a satisfactory background check.
* Note - some benefits may only be available to or vary slightly for full time employment status vs part time status.
For additional details including our full equal opportunity statement, texting/outreach communication authorization, physical requirements of the job and more, please visit: ***********************************************************
$25k-31k yearly est. 37d ago
Analytical Chemist - Antibody-Drug Conjugates
Eli Lilly and Company 4.6
Indianapolis, IN 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:
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 motivated individuals who are determined to make life better for people around the world.
The Bioproduct Research and Development (BR&D) organization delivers new medicines to patients through the development and commercialization of insulins, peptides, oligonucleotides, monoclonal antibodies, novel therapeutic proteins, and gene therapy systems. BR&D is a multidisciplinary group with deep technical expertise that works collaboratively with our discovery and manufacturing colleagues. Located in Indianapolis, IN, scientists have full access to Lilly's deep pharmaceutical development expertise and engineering capabilities. In this role, you will be part of a diverse team of analytical chemists, pharmaceutical scientists, and engineers delivering product and process understanding to deliver the antibody-drug conjugate portfolio. Ideal candidates will possess experience across multiple analytical techniques, demonstrate an aptitude in technical problem solving, and be motivated to work both independently and collaboratively in a dynamic environment. Top candidates for this position will be able to:
Develop analytical methods to support progression of the antibody-drug conjugate portfolio.
Evaluate and/or implement new analytical technologies/methods to advance Lilly's current analytical capabilities for bioproduct testing with a focus on state-of-the-art separation sciences capabilities.
Generate key data and information applying HPLC, UHPLC, capillary electrophoresis, LCMS and/or other instrumental analysis techniques.
The ideal candidate will demonstrate learning agility and be able to work with cross-functional teams.
Position Responsibilities:
Engage with scientists across Eli Lilly's Development and Manufacturing organizations to develop and validate robust analytical methods
Identify and exploit new scientific concepts, strong problem-solving skills, and be self-motivated to contribute across multiple projects
Strong written and verbal communication to speak to both technical and business-related implications of your work.
Basic Qualifications:
BS or MS in Analytical Chemistry, Biochemistry, Chemistry, or a related field.
Additional Skills/Preferences:
Experience with chromatographic separations and/or spectroscopic methods and methods for the analysis of antibody-drug conjugates.
Experience with method validation and transfer.
Demonstration of scientific and people leadership skills.
Effective oral and written communication skills.
The ability to work productively in an interdisciplinary team environment.
Ability to balance multiple activities, prioritize and handle ambiguity.
Additional Information:
Potential exposure to chemicals, allergens, and loud noises
Travel: 0 to 10%
Position Local: Indianapolis, IN; Lilly Technology Center-North (LTC-N)
Lilly is an EEO/Affirmative Action Employer and does not discriminate based on race, gender, protected veteran status, disability, or any other legally protected status
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$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.
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