Principal Manager, CMC External Manufacturing
About The Position
AbbVie is hiring a Principal Manager, CMC External Manufacturing in North Chicago, Illinois. This onsite, individual-contributor role provides cGMP manufacturing and technical oversight for drug substance and drug product manufacturing at CROs and CDMOs, including oversight of external budgets. The position ensures that external partners comply with quality, financial, ethical, and regulatory standards, leads Supplier Review Board activities, and conducts site visits for diligence and audits. It also monitors pipeline needs to support CMC supply chain planning and regulatory filings. The position does not include people management.
Requirements
- PhD in chemistry, organic chemistry, chemical engineering, analytical chemistry, or a related field, or foreign equivalent, plus at least 1 year working in an academic or industry setting supporting development and synthesis of pre-clinical or clinical-stage small molecules or natural products; alternatively, a master's degree in one of these fields or foreign equivalent, plus at least 3 years of such experience.
- For the PhD pathway, at least 1 year of experience preparing written and oral presentations of scientific material for peers, business stakeholders, and senior management; alternatively, 3 years for the master's pathway.
- For the PhD pathway, at least 1 year of experience supporting reaction optimization and developing scale-up protocols; alternatively, 3 years for the master's pathway.
- For the PhD pathway, at least 1 year of experience supporting the preparation of research proposals and managing research projects; alternatively, 3 years for the master's pathway.
- For the PhD pathway, at least 1 year of experience authoring and delivering publications and presentations to the broader scientific community; alternatively, 3 years for the master's pathway.
- Work experience may be gained concurrently.
- A combination of education, work experience, and training is acceptable.
Responsibilities
- Manage drug substance and drug product cGMP manufacturing and technical oversight at CROs and CDMOs.
- Manage external manufacturing budgets.
- Ensure CRO/CDMO compliance with quality, financial, ethical, and regulatory standards.
- Lead Supplier Review Board activities.
- Conduct site visits for diligence and audits.
- Stay updated on pipeline needs for CMC supply chain planning.
- Support regulatory filings.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in short-term and long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
Ph.D. or professional degree
