Drug Substance Manufacturing Supervisor

Global Life Science Hub is excited to collaborate with an innovative biopharmaceutical company leading advancements in cutting-edge drug delivery technologies. Following two recent FDA approvals, they are gearing up for substantial growth. By 2025, they will launch new internal manufacturing facilities that will triple their production capacity, driving a significant operational expansion.

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 3^rd 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.

Apply

Global Life Science Hub is a specialized Life Science headhunting firm. We place professionals across the United States and Europe for various Biotechnology, Pharmaceutical, and CDMO companies, ranging from small start-ups to large global organizations.

If you’re interested, please apply below. If this position doesn’t suit you, visit our website for more vacancies – www.glshub.com