Principal - QA API External Manufacturing Peptides

Responsibilities

• Provide QA oversight of external API manufacturing, including batch disposition, deviation management, and change control.
• Conduct and support audits to ensure compliance with cGMP regulations and Lilly quality standards.
• Review and approve quality documentation, including batch records, validation documents, stability data, and analytical methods.
• Partner with internal functions and external manufacturers to resolve quality issues and drive continuous improvement.
• Support new product introductions, technology transfers, and quality agreement management.
• Lead investigations of quality events, deviations, and OOS results, identifying root causes and implementing CAPAs.

Basic Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Pharmacy, Chemical Engineering, or science related field.
• 5+ years of pharmaceutical or biopharmaceutical industry experience, with a strong emphasis in QA, preferably supporting API manufacturing and external supply.
• Experience supporting GMP manufacturing operations in a QA shop floor environment.
• Strong knowledge of cGMP regulations and global quality requirements.
• Ability to travel domestically and internationally as needed.

Additional information

Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Skills and Preferences

• Strong understanding of API manufacturing processes, analytical testing, and quality control principles.
• Strong preference for candidates with hands-on experience supporting biologics, large molecule, or peptide (TIDES) drug substance manufacturing.
• QA shop floor experience.
• Excellent problem-solving, decision-making, and communication skills, with the ability to convey complex quality and technical information effectively.

Additional information

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

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