Drug Substance Manufacturing Supervisor

To support this next phase, we are recruiting for a Drug Substance (DS) Supervisor who will play a critical role in managing the production activities for Biologics Manufacturing for the 3rd shift operation. This includes supervising cell culture fermentation, protein purification, and aseptic processing to produce high-quality drug substances.

Responsibilities:

• A working supervisor position is shift lead.
• Participate in all drug substance related manufacturing process. Perform (Where needed) and review the process to ensure compliance with the requirements listed in respective batch record.
• Provides daily supervision on the floor to personnel in the efficient use of equipment and materials to produce quality products under cGMP in accordance with the production plan.
• Provides coaching, counseling, development, discipline and recognition of direct staff, including performing annual performance reviews.
• Responsible for maintaining alignment with department direction, goals and objectives.
• Promotes the use of safe work practices during all production and ensures all external and company policies and EHS standards are met daily.
• Responsible for training personnel on equipment, processes and Standard Operating Procedures (SOPs).
• Trains and develops personnel, develops and maintains packaging schedules, and manages within the department budget.
• Ensures that projects are completed on schedule per established procedures.
• Participate in execution of qualification and validation activities.
• Participate in process related investigation(s) and implement CAPA derived from investigation outcome in timely manner.
• Author and reviews SOPs and other documents to ensure integration of cGMPs and improve process efficiency.
• Works collaboratively to ensure flow of product, sharing of best practices and lean behaviors.
• Performs process monitoring, including use of databases, documents and/or spreadsheets to support business reporting requirements.
• Performs ongoing operational tasks of organization unit, actively assists, or provides direction to subordinates as required.
• Responsible for final review of completed documentation per compliance standards and establish timelines.
• Investigates and resolve problems, identifying root cause, and proposing process improvements through clear communication to senior management.
• Participation and/or leadership role in multi-functional project teams as necessary.
• Other tasks as requested by management.

Experience/Qualifications:

• Bachelor’s degree, in engineering, pharmaceutical, related life science and at least 5 years of experience
• Master’s degree, in engineering, pharmaceutical, related life science and at least 2 years of experience
• Upstream and Downstream manufacturing experience
• Prior Drug Substance Manufacturing experience
• Prior aseptic process execution and supervisory experience is strongly preferred.