Please note: Supervisor/Manager level candidates who have upstream manufacturing experience and API/drug substance, are highly preferred.
About This Role
This role leads a shift team and is responsible for manufacturing bulk drug substance. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours (will move to 2-2-3 fixed schedule come operations phase).
What You’ll Do
Project Phase (Through Mid-2025)
- 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, but not limited to: travel & expense, time reporting, and time off that directly impact employees
Operations Phase (Starting Mid-2025)
- Provides on-the-floor leadership for a shift team of up to 7-10 manufacturing associates
- Coordinates the execution of the manufacturing schedule through daily shift assignments, lead daily huddles, and manages escalations
- Fosters an inclusive, people-first culture with regular communication, conducting 1:1s on a defined cadence with direct reports
- Maintains a safe and cGMP compliant environment by ensuring direct reports have correct and up-to-date training
- Supports manufacturing investigations and continuous improvement projects
- Coordinates with other functional areas for additional activities requiring access to the manufacturing space and equipment, such as but not limited to: maintenance, calibration activities and the use of manufacturing equipment
- Administers company policies, such as but not limited to: time reporting, time off, shift policies, and inclement weather that directly impact manufacturing employees
- Performs other job as assigned
Who You Are
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.
Basic Requirements
- High 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
- Military Experience in combination with large pharma/biotech operations or projects
- Experience in manufacturing of biological products, familiar with GMP/GLP requirements
- Previous experience leading, supervising or managing others
