Senior/Principal Scientist - Quality Control Project Manager jobs in United States
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Eli Lilly and Company · 1 day ago

Senior/Principal Scientist - Quality Control Project Manager

Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, focused on discovering and delivering life-changing medicines. The Senior/Principal Scientist - Quality Control Project Manager will oversee the quality control laboratory's efforts in ensuring that products meet predetermined standards, coordinating testing with internal and external partners, and managing project timelines and deliverables.

BiotechnologyHealth CareMedicalPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Serve as a liaison between contract manufacturers and Lilly to perform coordination, review, and interpretation of quality control product testing data and serve as the initial point of contact for all quality control-related issues
Provide analytical support, project leadership, and/or technical direction for testing performed internally to LP2 or by third-party contract partners
Oversee and participate in the transfer of analytical methods, including setting strategic direction, authoring and reviewing method certification documentation, execution of laboratory testing, and investigation of observations
Leverage organizational understanding to identify correct SMEs to utilize their technical skills to lead or perform in-depth investigations into out of spec results and aberrant data
Track project progress and performance, including maintenance of transparent and accessible project documentation (timelines, budgets, status), ensuring all team members and partners have access to up-to-date project information
Define project scope, objectives, and deliverables in collaboration with partners; develop detailed project plans including timelines, milestones, and resource allocation; identify project requirements and ensure alignment with organizational goals
Provide technical oversight for Periodic Management Reviews. Leads resolution of technical issues including those related to control strategy and manufacturing
Help develop a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
Interact effectively with business partners and auditors to communicate and resolve issues and gain a clear and accurate understanding of each other’s requirements
Network with groups internal and external to Lilly to understand best practices, share knowledge, participate in technical planning, and to ensure customer needs are met
Help define and execute inspection readiness activities for manufactured products
Employ excellent communication skills to manage internal and external relationships, perform effective investigations and disseminate actionable outputs
Build and maintain relationships with development partners and central technical organizations

Qualification

GMP manufacturing experienceAnalytical method transferProject managementLarge molecule testingRoot Cause AnalysisContinuous improvementCompliance knowledgeInterpersonal skillsCommunication skillsProblem-solving skills

Required

Bachelors (4-year) degree in a science field related to chemistry, microbiology, or biology
4+ years of demonstrated relevant experience in a GMP manufacturing environment

Preferred

Demonstrated proficiency in project management, data management practices, and ability to coordinate complex projects
Demonstrated ability to manage and prioritize competing priorities and to appropriately communicate verbally and in writing to various audiences
Strong oral and written communication skills and demonstrated through documentation and presentation skills
Proficiency in delivering complex tasks and/or tasks that are cross-functional
Experience with large molecule and/or viral vector testing techniques
Demonstrated strong problem-solving skills. Preferred training and demonstrated proficiency in Root Cause Analysis methodology
Demonstrated strong interpersonal interaction skills
Ability to focus on continuous improvement
Deep understanding of compliance requirements and regulatory expectations

Benefits

Company bonus
401(k)
Pension
Vacation benefits
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Company

Eli Lilly and Company

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We're a medicine company turning science into healing to make life better for people around the world.

H1B Sponsorship

Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)

Funding

Current Stage
Public Company
Total Funding
$6.5M
2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO

Leadership Team

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David Ricks
Chair, CEO
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Lucas Montarce
Executive Vice President and Chief Financial Officer
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Company data provided by crunchbase