Associate Director – QC – IAPI Analytical Sciences jobs in United States
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Eli Lilly and Company · 1 day ago

Associate Director – QC – IAPI Analytical Sciences

Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, focused on discovering and bringing life-changing medicines to those in need. The Quality Control Associate Director will lead the Indianapolis API QC Analytical Sciences team, establishing key capabilities and driving analytical initiatives to support site operations and commercialization efforts.

BiotechnologyHealth CareMedicalPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Uphold company values of Integrity, Excellence, and Respect for People
Ensure employees maintain required training and adhere to company policies and guidelines
Recruit and manage team members’ performance
Develop and execute a comprehensive technical capability strategy to ensure site competencies in fields including but not limited to analytical stewardship, chromatography, Mass Spectroscopy, and Process Analytical Technology
Provide leadership and oversight for method development and transfers
Drive improvement of the analytical control strategy, continuous optimization of methods leveraged in the laboratory, and continued modernization of equipment and processes used within the laboratory
Identify and support the implementation of new technologies/methods that offer significant advantages in cost reduction, compliance improvement or process control
Prioritize analytical initiatives based on business impact and risk analysis
Provide resources and oversight to ensure the analytical control strategy from raw materials through drug substance is technically sound, cost effective, compliant and sustainable for specific molecules
Provide resources and oversight for the troubleshooting and investigation of major analytical issues
Collaborate with site operations and TS/MS to develop innovative analytical solutions that drive process efficiency and product quality
Support global Analytical Quality Control Organization initiatives as applicable
Review and/or approve documents as required
Support regulatory inspections and ensure inspection readiness
Develop and implement technical coaching and mentoring strategy

Qualification

Analytical stewardshipChromatographyMass SpectroscopyProcess Analytical TechnologyMethod developmentData analysisCGMP knowledgeSupervisory experienceStatistical skillsInterpersonal skillsProblem-solving skillsAttention to detailCommunication skills

Required

Bachelor's degree in a science field related to the laboratory (e.g., chemistry, microbiology or biology)
5 years of relevant experience in a cGMP lab
2+ years supervisory experience
Demonstrated strong data analysis and documentation skills
Demonstrated attention to detail, critical decision making, and problem-solving skills
Demonstrated strong oral and written communication and interpersonal interaction skills
Knowledge of cGMPs and quality systems
On-site presence required

Preferred

Experience in method development and validation
Experience with a broad range of analytical techniques
Knowledge of ICH guidelines applicable to analytical sciences
Strong statistical skills

Benefits

Company bonus
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
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