Supervisor - DSM (Upstream) Leader
3 weeks ago
This position leads a shift team and is responsible for manufacturing bulk drug substance in a 24/7 operational environment. The role may require flexibility with working hours.
Key Responsibilities- Supports Factory Acceptance Testing (FAT) at the vendor site as required
- Supports Site acceptance Installation Verification (IV), Operational Verification (OV), and Performance Qualification (PQ) testing, including protocol generation, as applicable
- Performs other operational readiness tasks as required, such as document review/approval, team onboarding, and materials management
- Supervises manufacturing associates on technical and operational topics, such as area unit operations and equipment
- Administers company policies, such as travel & expense, time reporting, and time off that directly impact employees
You have a high degree of knowledge and expertise of the operation of production equipment in their respective functional area.
You have an understanding of manufacturing run cadence and order of shift activities.
You have expertise in cGMP, safety and FDBN operational procedures.
You have a strong cross-functional partnership with Quality, Process Sciences, Process Engineering and others.
You are able to create and maintain a collaborative and inclusive team.
You have the ability to travel and have a valid passport.
Education and ExperienceHigh School Diploma or GED with 8 years of experience from a similar role in large pharma/biotech operations or projects.
Preferred Requirements: BA/BS Degree in Life Sciences with 4+ years of experience from a similar role in large pharma/biotech operations or projects.
OR Associates Degree in Life Sciences and 6+ years of experience from a similar role in large pharma/biotech operations or projects.
OR Military Experience of equivalence.
Experience in manufacturing of biological products, familiar with GMP/GLP requirements.
Previous experience leading, supervising or managing others.
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