Production Manager - Team Leader

Production Manager / Team Leader

Type: Full Time

Location: Framingham, MA - Fully Onsite

Shift: 6:00 AM - 2:30 PM

Overview
The Production Manager / Team Leader is responsible for leading the manufacturing and making sure they meet company SA GMP requirements. This role ensures production is executed in alignment with USDA Outlines of Production, Special Outlines, European Regulatory Dossier specifications, and internal procedures. The position oversees daily operations of the antigen manufacturing support group and ensures accurate documentation, compliance, and team performance.

Primary Responsibilities
• Lead the production of P45 and QA‑21 adjuvant according to established procedures and regulatory requirements.
• Supervise daily operations of the antigen manufacturing support team and manage all direct reports.
• Maintain accurate and up‑to‑date data trending.
• Oversee multiple direct reports, assign goals, and complete annual performance reviews in Workday.
• Review manufacturing batch records for accuracy and compliance.
• Manage inventory of laboratory supplies and raw materials required for P45 and adjuvant production.
• Train new technicians in all relevant manufacturing techniques.
• Organize and oversee preventive maintenance and analytical systems.
• Document and oversee training for new hires.
• Provide coverage for manufacturing roles as needed to ensure continuity of operations.
• Adhere to all Standard Operating Procedures, Manufacturing Control Procedures, cGMP standards, safety policies, attendance policies, and the company code of conduct.

Secondary Responsibilities
• Review completed equipment clean‑and‑use logs, temperature monitoring records, and differential pressure monitoring logs within manufacturing areas.

Required Abilities
• In‑depth knowledge of biologics production within a recombinant bacterial biotech manufacturing environment.
• Knowledge of regulatory guidelines related to the manufacture, quality control, and quality assurance of veterinary biological products.
• Strong communication, leadership, and organizational skills.
• Ability to read, write, speak, and comprehend English.
• Ability to stand, walk, lift, and perform repetitive tasks.
• Proficiency in computer applications including spreadsheets, word processing, and graphing tools.
• Ability to work independently and apply appropriate problem‑solving techniques.
• Strong judgment and decision‑making skills based on data analysis.
• Understanding of experimental design fundamentals and proper control use.
• Ability to organize and prioritize both personal and departmental tasks effectively.

Education and Experience
• Bachelor’s degree in Biology, a Biotechnology certificate, or an AS/BS degree in a scientific discipline.
• Minimum of 4 years of relevant experience in a cGMP biopharmaceutical manufacturing environment.