Current jobs related to Principal Associate-PRD QA CT Drug Product mfg - Indianapolis, Indiana - Eli Lilly and Company

  • PRD QA Engineer

    3 days ago

    Indianapolis, Indiana, United States Eli Lilly Full time

    Job Title: PRD QA EngineerAt Eli Lilly, we are committed to delivering high-quality products that meet the needs of our customers. We are seeking a highly skilled PRD QA Engineer to join our team.Job Summary:The PRD QA Engineer will be responsible for providing quality oversight of all materials used in clinical trials. This includes supporting biologic drug...

  • PRD QA Sr. Director CT DP Manufacturing Lead

    5 days ago

    Indianapolis, Indiana, United States BioSpace, Inc. Full time

    Job Title: PRD QA Sr. Director CT DP ManufacturingAt BioSpace, Inc., we are committed to delivering high-quality products to our customers. We are seeking a highly skilled and experienced PRD QA Sr. Director CT DP Manufacturing to join our team.Job Summary:The PRD QA Sr. Director CT DP Manufacturing will be responsible for leading the quality assurance team...

  • PRD QA Engineer

    6 days ago

    Indianapolis, Indiana, United States Eli Lilly Full time

    Job SummaryWe are seeking a highly skilled PRD QA Engineer to provide quality oversight of all materials used in clinical trials. The successful candidate will be responsible for ensuring compliance with quality systems and current Good Manufacturing Practices (cGMP).Key ResponsibilitiesProvide technical guidance and leadership in interactions with business...

  • Production Associate

    5 days ago

    Indianapolis, Indiana, United States Baxter Full time

    Production Associate - FillBaxter is a leading global innovator of medical products and therapies. We are seeking a highly motivated and detail-oriented Production Associate - Fill to join our team.About the Role:Inspect, print, fill, and seal flexible containers with IV therapies, premixed drugs, and sterile solutions.Maintain the printer by replacing...

  • Senior Principal Scientist

    3 weeks ago

    Indianapolis, Indiana, United States Lilly Full time

    Job SummaryWe are seeking a highly experienced and skilled Senior Principal Scientist to lead our dry product manufacturing efforts. As a key member of our team, you will be responsible for providing technical leadership and expertise in the development and commercialization of oral solid dosage forms.Key ResponsibilitiesProvide technical leadership and...

  • Senior Technical Lead

    3 days ago

    Indianapolis, Indiana, United States Lilly Full time

    Job Title: Sr Principal ScientistWe're seeking a highly skilled and experienced Sr Principal Scientist to join our team at Lilly. As a key member of our Dry Product Network, you will provide technical leadership for drug product manufacturing processes under development and in commercial production.Key Responsibilities:Serve as Manufacturing TS/MS...

  • CT Technologist

    1 week ago

    Indianapolis, Indiana, United States Eskenazi Health Full time

    Job SummaryWe are seeking a highly skilled and experienced CT Technologist to join our team at Eskenazi Health. As a CT Technologist, you will be responsible for performing standard CT procedures on designated sections of the body as required by physician orders.Key ResponsibilitiesProactively contribute to Eskenazi Health's mission by advocating for patient...

  • Production Associate

    2 weeks ago

    Indianapolis, Indiana, United States Baxter Full time

    About the RoleWe are seeking a highly skilled and detail-oriented Production Associate - Fill to join our team at Baxter. As a key member of our production team, you will play a critical role in ensuring the quality and safety of our sterile solutions.Key ResponsibilitiesFilling, assembling, and plugging flexible containers with solutions or premixed drugs...

  • Principal Mechanical Engineer

    4 days ago

    Indianapolis, Indiana, United States Innova Solutions Full time

    Job Title: Principal Mechanical EngineerWe are seeking a highly skilled Principal Mechanical Engineer to join our team at Innova Solutions. As a Principal Mechanical Engineer, you will be responsible for designing and developing new products and test hardware, as well as improving existing products.Key Responsibilities:Design and develop new products and...

  • Principal Project Engineer

    9 hours ago

    Indianapolis, Indiana, United States Vertex Aerospace LLC Full time

    Job Description:Vertex Aerospace LLC is seeking a highly skilled Principal Project Engineer to join our team in Indianapolis, IN. As a key member of our Project Engineering department, you will lead dynamic and multidiscipline development teams within the Weapon Systems Integration (WSI) product line.The successful candidate will be responsible for leading...

  • Production Associate 3rd Shift

    2 weeks ago

    Indianapolis, Indiana, United States Silver Line Full time

    Job SummaryWe are seeking a skilled Production Associate to join our team at Silver Line. As a key member of our production team, you will be responsible for fabricating and producing component parts for our final assembly of windows.Key ResponsibilitiesManufacturing Operations: Perform repetitive workstation operations to mass-produce windows, doors, and...

  • CT Technologist

    3 days ago

    Indianapolis, Indiana, United States Health & Hospital Corporation of Marion County Full time

    Job SummaryThe Radiologic Technologist I Cat Scan Specialist performs standard CT procedures on designated sections of the body as required by physician orders.Key ResponsibilitiesProactively contributes to Eskenazi's mission: Advocate, Care, Teach and Serve with special emphasis on the vulnerable population of Marion County.Models Eskenazi valuesPerforms...

  • Production Associate

    13 hours ago

    Indianapolis, Indiana, United States Daily Services LLC Full time

    Job OverviewWe are seeking a skilled and motivated Production Associate to join our team at Daily Services LLC in Marion, Ohio.This is a full-time position that offers a competitive compensation package and opportunities for career growth in a dynamic and industrial manufacturing environment.Key ResponsibilitiesWork collaboratively with a team to meet...

  • Principal Project Engineer

    10 hours ago

    Indianapolis, Indiana, United States The Computer Merchant, LTD. Full time

    Job Title:Principal Project EngineerJob Summary:The Principal Project Engineer will play a key role in supporting all phases of the development process, working across disciplines to develop technical solutions and leading a multi-discipline team. This includes Systems, Hardware, and Software Engineering functions, as well as other disciplines such as...

  • Production Associate

    2 weeks ago

    Indianapolis, Indiana, United States BAXTER Full time

    About the RoleBaxter is a leading global healthcare company that is committed to saving and sustaining lives. We are seeking a highly skilled and detail-oriented Production Associate to join our team in a critical role that contributes to our mission.Key ResponsibilitiesInspect and ensure that flexible containers, over-pouches, printed bags, and their...

  • Senior Principal Electrical Engineer

    3 days ago

    Indianapolis, Indiana, United States Global Technical Talent Full time

    Senior Principal Electrical Engineer OpportunityWe are seeking a highly skilled Senior Principal Electrical Engineer to join our Hardware Engineering team in Indianapolis, IN. As a Senior Principal Electrical Engineer, you will lead a team of talented engineers in the design, analysis, simulation, test, and integration of digital electronic modules, FPGAs,...

  • Senior Principal Electrical Engineer

    4 days ago

    Indianapolis, Indiana, United States Compunnel Full time

    Senior Principal Electrical EngineerWe are seeking a highly skilled Senior Principal Electrical Engineer to join our Hardware Engineering team in Indianapolis, IN.As a Senior Principal Electrical Engineer, you will lead a team of talented engineers in the design, analysis, simulation, test, and integration of digital electronic modules, FPGAs, and/or CCAs...

  • CT Technologist

    3 weeks ago

    Indianapolis, Indiana, United States Eskenazi Health Full time

    Job SummaryEskenazi Health is seeking a highly skilled and experienced Radiologic Technologist II to join our team as a CT Technologist. This is a critical role that requires a strong foundation in radiologic technology and a passion for delivering exceptional patient care.Key ResponsibilitiesPerform standard CT procedures on designated sections of the body...

  • CT Technologist

    2 weeks ago

    Indianapolis, Indiana, United States Eskenazi Health Full time

    Job SummaryEskenazi Health is seeking a highly skilled Radiologic Technologist II to join our team as a CT Technologist. This is a critical role that requires a strong foundation in radiologic technology and a passion for delivering exceptional patient care.Key ResponsibilitiesPerform standard CT procedures on designated sections of the body as required by...

  • Senior Principal Electrical Engineer

    3 days ago

    Indianapolis, Indiana, United States Global Technical Talent Full time

    Senior Principal Electrical EngineerWe are seeking a highly skilled Senior Principal Electrical Engineer to join our Hardware Engineering team in Indianapolis, IN.As a Senior Principal Electrical Engineer, you will lead a team of talented engineers in the design, analysis, simulation, test, and integration of digital electronic modules, FPGAs, and/or CCAs...

Principal Associate-PRD QA CT Drug Product mfg

3 months ago

Indianapolis, Indiana, United States Eli Lilly and Company Full time

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:
Product Research and Development (PRD) Quality Assurance (QA) supports the delivery of the Lilly pipeline by providing oversight of the manufacturing, packaging, and distribution of the medicines needed for clinical trials (CT). As the QA Principal Associate, CT Drug Product Manufacturing, you will be responsible for the quality oversight of CT drug product manufacturing. CT Drug Product Manufacturing is responsible for manufacturing parenteral and oral products at partner sites across the globe, both internally (e.g. B103, PR01) and externally.

Responsibilities:

The Quality Assurance Principal Associate performs Quality functions and oversight for PR&D drug product manufacturing. Assure the PR&D Quality System is in compliance with global regulations and aligned with current industry practices and the Lilly global quality standards, where appropriate. Advise local business on current quality system expectations and develop and implement plans to address local compliance gaps. Provide technical QA support by leading/participating in divisional projects and supporting the portfolio as needed.

Oversight of manufacturing collaboration partners.Perform pre-manufacture activities such as pre-approval of master batch records.Perform activities related to forward processing and final usage decision of batches.Advise business partners on quality system and regulatory requirements/interpretations.Partner with internal molecule project teams and external CPs on quality related matters, issue resolution, deviation investigations, etc., to ensure successful manufactures.Participate in or lead projects to continuously improve processes. Basic Requirements: Bachelor's or higher degree in a scientific field such as physical, chemical or biological sciences, pharmaceutics, engineering, pharmacy, computer science, or other scientific areas of study.A minimum of 5 years of quality unit or relevant GMP experience.Strong problem solving, interpersonal and leadership skills
Additional Skills/Preferences:Additional experience in areas such as development operations, engineering, technical services, manufacturing operations, analytical/laboratory, and/or regulatory affairs is preferred.Previous experience with parenteral drug product manufacturing.Previous experience with compounded sterile preparations.Previous experience with SAP, Trackwise, Quality Docs.
Additional Information:Potential domestic and international travel less than 20% per year. Occasional travel may be required for collaboration partner oversight, training, conferences, etc. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups. #WeAreLilly