Principal - QA API External Manufacturing Peptides

Regulatory Toolkit; Indianapolis (IN); Presencial; USD 65.000 - 169.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Company bonus

401(k) plan

Pension plan

Vacation benefits

Medical coverage

Dental coverage

Vision coverage

Flexible benefits

Life insurance

Paid time off

Well-being programs

Descripción de la vacante

Lilly's Active Pharmaceutical Ingredient External Manufacturing (API-EM) organization oversees the production of large molecule and biologics APIs at contract manufacturing sites worldwide. This role provides QA oversight of external API manufacturing, including batch disposition, deviation management, change control, and CAPA-driven improvements.

The qualified candidate will conduct audits, review quality documentation, manage the QA shop floor operations for GMP, support tech transfers and new

Formación

• Bachelor's degree in chemistry, biochemistry, pharmacy, chemical engineering or related science.
• 5+ years in pharma/biopharma QA, preferably API manufacturing and external supply.
• Experience supporting GMP manufacturing on a QA shop floor.
• Strong knowledge of cGMP regulations and global quality requirements.
• Ability to travel domestically and internationally as needed.

Responsabilidades

• 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, batch records, validations, stability data, and analytical methods.
• Collaborate with internal functions and external manufacturers to resolve quality issues and drive improvements.
• Support new product introductions, technology transfers, and quality agreement management.
• Lead investigations of quality events, deviations, and OOS, identifying root causes and CAPAs.

Conocimientos

QA oversight

cGMP knowledge

External API manufacturing

Audits

CAPA

Deviations

Analytical methods

Travel flexibility

Educación

Bachelor's degree in Chemistry/ Biochemistry/ Pharmacy/ Chemical Engineering

Descripción del empleo

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life‑changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life‑changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Your floor QA experience is what makes you ready for this role.

Lilly's Active Pharmaceutical Ingredient External Manufacturing (API-EM) organization oversees the production of large molecule and biologics APIs at contract manufacturing sites worldwide

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.

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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. Please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 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

$65,250 - $169,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

• eligible 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
• 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