Summary:
The Shift Manager leads and drives execution of commercial manufacturing processes for therapeutic proteins per cGMP electronic work instructions and production records. Responsible for managing a team focused on manufacturing execution, technical assessment, compliance culture, and process troubleshooting/investigations, data analysis, and process improvements.
Major Duties and Responsibilities:
- Provide direct oversight of manufacturing unit operations (e.g., bioreactors, chromatography, media/buffer prep; automation systems like Delta V/Syncade; historians; business systems such as SAP, Veeva Vault, Maximo).
- Drive Right First Time (RFT) through real-time training, guidance, and problem-solving.
- Select/develop the team using internal/external resources.
- Ensure adherence to GMPs and SOPs.
- Coordinate daily work and distribute tasks per manufacturing schedule.
- Maintain schedule adherence/cycle time; report variances and impacts to cross-functional groups.
- Manage shift communications (huddles, meetings, shift handover).
- Perform walk-down/checks for critical operations; review critical attributes and drive decisions.
- Partner with Manufacturing Operational Engineer Support for daily data review/trends.
- Ensure complete/accurate shift notes; communicate safety incidents and significant deviations.
- Initiate response for critical issues; manage progress and communicate to management.
Knowledge and Skills (Qualifications):
- BS in science/engineering/biochemistry or related field (or equivalent) highly desired.
- 6+ years direct biologics manufacturing experience; supervisory/leadership experience highly desired.
- Extensive knowledge of SOPs and cGMPs in a regulatory environment.
- Experience with pharmaceutical/biopharmaceutical manufacturing processes (pharmaceutical technology, tech transfer, process development, manufacturing support).
- Adaptable to fast-paced, complex, changing environments.
- Effective communication and technical writing.
Benefits (if applicable):
- Health coverage (medical, pharmacy, dental, vision); wellbeing support; 401(k) and protection benefits (e.g., disability, life insurance).
- Paid time off per role eligibility (e.g., flexible/unlimited for US exempt employees; vacation/holidays for certain locations).