Current jobs related to Sr Principal Associate - Indianapolis - Eli Lilly and Company

  • Sr Principal Engineer

    3 months ago

    Indianapolis, 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...

  • Sr Principal Engineer

    2 months ago

    Indianapolis, 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...

  • Principal Associate-PRD QA CT Drug Product mfg

    3 months ago

    Indianapolis, 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...

  • Principal Associate

    2 months ago

    Indianapolis, 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...

  • Intake Associate

    4 weeks ago

    Indianapolis, United States TEKsystems Careers Full time

    *TEKsystems is looking to hire several Intake Specialists for a large healthcare companies in Indianapolis, IN!* ***if you have healthcare revenue cycle experience, please send your most updated resume to rsison @ teksystems.com - these resumes will be reviewed first!*** *Description:* The Patient Estimate Department takes calls from patients and helps...

  • Intake Associate

    4 weeks ago

    Indianapolis, United States TEKsystems Careers Full time

    *TEKsystems is looking to hire several Intake Specialists for a large healthcare companies in Indianapolis, IN!* ***if you have healthcare revenue cycle experience, please send your most updated resume to rsison @ teksystems.com - these resumes will be reviewed first!*** *Description:* The Patient Estimate Department takes calls from patients and helps...

  • Sr. Director TS/MS

    2 months ago

    Indianapolis, 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...

  • Sr. Director TS/MS

    4 months ago

    Indianapolis, 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...

  • Intake Associate

    1 month ago

    Indianapolis, United States TEKsystems Full time

    TEKsystems is looking to hire several Intake Specialists for a large healthcare companies in Indianapolis, IN! **if you have healthcare revenue cycle experience, please send your most updated resume to rsison @ - these resumes will be reviewed first!** Description: The Patient Estimate Department takes calls from patients and helps create an...

  • Electrical Power Engineering Principal

    18 hours ago

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

    Job SummaryWe are seeking a highly skilled Electrical Power Engineering Principal to join our team at BioSpace, Inc. This is a critical role that will provide technical leadership and expertise in electrical power engineering, driving innovation and excellence in our organization.Key ResponsibilitiesProvide technical leadership and expertise in electrical...

  • Financial Accounting Analyst Sr

    2 months ago

    Indianapolis, United States Elevance Health Full time

    Anticipated End Date: 2024-08-09 Position Title: Financial Accounting Analyst Sr - FHPS Job Description: Financial Accounting Analyst Sr - FHPS Location: This position will work a hybrid model (remote and office). The ideal candidate will live within 50 miles of one of our Elevance Health PulsePoint locations listed on our requisition. At Federal Health...

  • Sr. Principal Chemist

    3 months ago

    Indianapolis, 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...

  • Principal - Quality Assurance

    4 months ago

    Indianapolis, 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...

  • Inflation Reduction Act

    4 weeks ago

    Indianapolis, United States Resource Innovations Full time

    Job DescriptionJob DescriptionResource Innovations is seeking an Energy Efficiency Program Principal, Government Services in Indianapolis, Indiana with significant experience managing energy efficiency, demand response, federally funded, and other customer-focused programs to join our growing team. As the State Principal with Resource Innovations, you will...

  • Energy Efficiency Program Principal

    3 weeks ago

    Indianapolis, Indiana, United States Resource Innovations Full time

    Job SummaryWe are seeking an experienced Energy Efficiency Program Principal to join our team at Resource Innovations in Indianapolis, Indiana. As a key member of our Government Services team, you will be responsible for managing and delivering energy efficiency and demand response programs on behalf of North American utilities and federally funded...

  • Senior/Principal/Sr. Principal Analytical Scientist

    4 months ago

    Indianapolis, 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...

  • Principal Electrical Design Specialist

    3 weeks ago

    Indianapolis, Indiana, United States PHYSIOLOGIC DEVICES, INC. Full time

    About the OpportunityPhysiologic Devices, Inc. is seeking an experienced Electrical Design Engineer to join our team. As a key member of our engineering department, you will be responsible for designing and developing implantable grade electronics for a Class III medical device.The CompanyWe are a small, fast-paced company dedicated to delivering innovative...

  • Provider Network Manager Sr

    6 days ago

    Indianapolis, Indiana, United States Elevance Health Full time

    Job SummaryWe are seeking a highly skilled Provider Network Manager Sr to join our team at Elevance Health. This role will be responsible for developing and managing our provider network through contract negotiations, relationship development, and servicing.Key ResponsibilitiesDevelop and implement strategies to build and maintain strong relationships with...

  • Senior Technical Lead

    4 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...

  • Intake Associate

    4 weeks ago

    Indianapolis, IN, United States TEKsystems Careers Full time

    TEKsystems is looking to hire several Intake Specialists for a large healthcare companies in Indianapolis, IN!***if you have healthcare revenue cycle experience, please send your most updated resume to rsison @ teksystems.com - these resumes will be reviewed first!***Description:* The Patient Estimate Department takes calls from patients and helps create an...

Sr Principal Associate

4 months ago

Indianapolis, 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:

Drug Product External Manufacturing Quality Assurance assures patients worldwide of safe and efficacious drug products, through effective quality oversight contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations, and termination.

Drug Product External Manufacturing Quality Assurance is committed to creating partnerships that facilitate open communication and maintaining effective relationships with our alliance partners, contract manufacturers, and internal business customers.

Key Objectives/Deliverables:

DPEM Laboratory Secondary Loop Subject Matter Expert provides oversight, assistance, and guidance to Contract Manufacturers (CMs) and other DPEM members for lab activities. Secondary loop is responsible for improving technical capabilities, supporting operational control strategy, resolution of the most critical/complex deviations and leading complex projects.

This role provides guidance to primary loop with respect to daily CM laboratory activities and leads/participates in method transfers and method/process validations to ensure that laboratory activities conducted by CMs are executed in accordance with company quality policies and procedures and comply with current Good Manufacturing Practice (cGMP) guidelines and regulations.

Oversight of Laboratory and Stability Quality System and operations include the following:

  • Subject Matter Expert and Technical Mentor for Laboratory system quality elements. Provide feedback, coaching, mentoring to the personnel on the interpretation of corporate and regulatory GMP requirements (GQS) related to laboratory topics.
  • Improve DPEM technical capabilities by providing guidance to primary loop representatives.
  • Through liaison with DPEM Management and Quality staff monitor the performance at contract manufacturers and identify concerns as relevant.  Escalate concerns in a timely manner with recommendations.
  • Provide support for onsite and remote Inspections/Audits (observation and answers), before during and after inspection.
  • Provide training in relation with Laboratory topics within DPEM and CMs upon request.
  • Develop internal network contacts for supporting investigations, keeping aware of emerging topics in Lilly and understanding the impact on Contract Manufacturing Laboratory activities.
  • Develop strategies for ensuring that Contract Manufacturers are aware of emerging laboratory trends and provide support (as needed) to implement their plans for meeting the standards.
  • Participate in the creation and review of local procedures related to laboratory quality activities.
  • Review new and revised standards related to the laboratory
  • Complete related assessments and determine impact on DPEM processes and procedures. Work with DPEM management and Quality Systems owners to develop and create appropriate action plan to ensure alignment with required standards.
  • Review, maintain and improve DPEM Standard Operating Procedures (SOPs) related to laboratory (Reference standards, Pharmacopeia changes, Analytical investigations, and Laboratory accreditation) and Stability (Stability management).
  • Track and monitor laboratory metrics for trend for CMs/products included in the same platform (Dry and Parenteral).
  • Perform annual stability report including global standard changes and assessment and prepare periodic updates of the stability plan.

    Contract Manufacturing support (as required):

    • Provide guidance and support for deviations, change controls, CAPA identification, technical report writing, as needed.
    • Review/approve major deviations and change controls, technical reports, and any other analytical document, as needed.
    • Lead critical/complex deviations (as required).
    • Provide laboratory accreditation support. Perform the annual laboratory accreditation plan to ensure compliance to laboratory accreditation schedule across CM and follow up of identified actions status.
    • Provide oversight to DPEM stability program, including protocols, studies, metrics and routine overview of data and metrics.
    • Assess capabilities of existing CMs to produce additional products, particularly with regards to laboratory topics.
    • Provide support to the assessment of new laboratories/implementation of new products/ CM.
    • Provide support to analytical transfer activities. Review method transfer/validation protocols as required. 
    • Primary contact person for:
      • Global method changes impacting external manufacturing: Coordination with related QA contact of the impacted CM to confirm impact assessment, global method and change approval where applicable and local implementation oversight.
      • Global compendia changes, pharmacopeia notifications and updates. Evaluation of global compendia reports, impact assessment and notification management to the QA reps for impacted CMs.
      • Reference standards profiles changes: Management of global notifications for profiles publications, link with CRSO for profiles delays or cancelation.
      • Data integrity topics and initiatives related to the laboratory.
      • Provide method transfer certification support (New products, method changes requiring certification)
      • Facilitates communications between QA Leads/ CMs and global SMEs relating to laboratory and stability standards.
      • Provide support to the laboratory performance review and Stability program monitoring in scope of Joint Process Team dashboards, huddle boards, IOPs and Steering meetings reviews.

        Basic Qualifications

      • Education:
      • Bachelor’s Degree in Pharmacy, Chemistry, Biological Science or related Life Science or equivalent experience.
    • Experience:
    • Minimum 10+ Quality Control Laboratory experience in a GMP environment

      Additional Skills/ Preferences

    • Established technical, quality, and internal networks.
  • Experience with electronic data systems (Darwin/LIMs, SAP, Trackwise, QDocs).
Previous experience supporting parenteral manufacturing operations.Understanding of micro/sterility testing.Strong Coaching/Mentoring skills.Knowledge of laboratory quality system, method, and equipment.Technical understanding of GMPs and the Global Quality Standards.A thorough understanding of cGMPs and Global Quality Standards.Strong written and communication skills, especially attention to detail.Strong leadership, interpersonal and teamwork skills, able to work effectively in a cross functional team environment.Ability to organize, prioritize, multi-task and influence others.Strong decision making and problem-solving skills.Willingness to learn new technologies.Capability to work in a virtual and complex environment.Willingness to travel.Appreciation for cultural diversity.

Additional Information

Shift is days, but off hours may be necessary to support operations.Travel is possible, up to 30 %.

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 ( Lilly_Recruiting_Compliance@lists.lilly.com ) 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