What are the responsibilities and job description for the Supervisor, GMP Manufacturing, Biologics position at STC Biologics Inc?
STC Biologics is a boutique biologics contract development and manufacturing organization (CDMO). Our commitment to innovation, quality, and customer service sets us apart in the biopharmaceutical landscape. We are seeking a highly motivated, detail oriented, and experienced Supervisor of Biologics Manufacturing to join our dynamic team. The ideal candidate will oversee day-to-day operations in the biologics manufacturing department, draft and review GMP batch records, ensuring compliance with cGMP standards and based on STC's Quality Manual and SOPs, quality regulations, and safety protocols. This role is crucial to maintaining production efficiency and fostering a productive work environment.
- Key Responsibilities :
- Supervise and lead a team of manufacturing personnel in the production of biologic products.
- Technical expert in GMP biologics production able to draft and review batch records
- Ensure compliance with all cGMP and safety regulations, conducting regular audits and inspections.
- Develop and implement standard operating procedures (SOPs) to enhance manufacturing processes.
- Collaborate with quality assurance and other departments to resolve production issues and deviations.
- Monitor production schedules, resource allocation, equipment and inventory management to meet project timelines.
- Train, mentor, and evaluate team members, fostering a culture of continuous improvement and professional development.
- Participate in process optimization to improve production efficiency.
- Prepare reports and documentation related to manufacturing activities and performance metrics
- Expert either in Upstream or Downstream Process execution
- Qualifications :
- Bachelors degree in Biotechnology, Biological Sciences, or a related field (Masters preferred).
- Minimum of 7 years of experience in biologics manufacturing, with at least 2 years in a supervisory role.
- Strong knowledge of cGMP regulations and biologics production processes.
- Excellent leadership, communication, and interpersonal skills.
- Ability to work in a fast-paced environment and manage multiple priorities.
- Proficiency in data analysis and problem-solving.