Principal External Manufacturing Specialist (Drug Product)

Principal External Manufacturing Specialist oversees external manufacturing contract operations (filling, assembly, packaging), including day-to-day activities; ensures timely completion of associated operations/documentation; and assists in monitoring cGMP compliance. Provides guidance to other specialists and consults management on contract manufacturing operations and GMP compliance issues.

Typical day responsibilities:
- Serve as operational contact for contract manufacturing/business partner sites for day-to-day activities.
- Coordinate external manufacturing: schedule batches, supply materials, direct shipment of bulk/finished product, track/monitor cycle times, provide supporting manufacturing documentation, and enlist required reports/technical expertise.
- Coordinate/oversee multiple external manufacturing activities across multiple sites.
- Liaise with internal departments (Quality Control, Quality Assurance, Supply Chain, Operations/Logistics, Legal, Regulatory, Strategic Sourcing) and contract manufacturers/business partners.
- Lead continuous process improvements; lead/support system/equipment implementation and/or strategy development.
- Lead or support investigations involving external manufacturing and associated shipping operations.
- Ensure product integrity and monitor cGMP compliance at external sites.
- Review pre-production master batch records and executed batch records.
- Author documents and procedures.
- Support internal and external audit operations.
- Analyze data for trends and potential issues.
- Travel 25% (target) or more as required.

This role might be for you if:
- You have knowledge of external manufacturing from formulation through final package.
- You understand cGMP and regulatory compliance (FDA; ICH; EU).
- Proficient in Excel, PowerPoint, Visio, Word, Oracle (or similar) and shared work environments.
- Strong interpersonal, written, and oral communication skills; high EQ.
- Ability to develop/interpret instructions with minimal supervision; resilient and flexible.
- German and/or French (oral and written) is a plus.

Education/Experience:
- BS/BA in a scientific discipline.
- cGMP manufacturing operations experience (clinical and/or commercial external manufacturing) including collaboration with CMOs/CROs.
- Principal Specialist: 8+ years (level determined by qualifications).

Application instructions:
- Apply now.