Production Manager - Team Leader (1117561)
- 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.
- Review completed equipment clean‑and‑use logs, temperature monitoring records, and differential pressure monitoring logs within manufacturing areas.
- 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.
- 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.
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