With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
The Manufacturing Production Services Supervisor leads the production services team during the 7:30 PM to 4:00 AM shift. This hands-on leader ensures facility cleaning, material staging, solution formulation, equipment startup and breakdown, and off-shift monitoring support manufacturing unit operations. The role partners with Quality, Engineering, and Supply Chain and reports to the Production Manager. Direct reports may include a Lead Production Service Associate and Production Service Associates I and II.
Responsibilities
- Supervise daily third shift production activities and enforce safety, quality, environmental, and personnel policies.
- Monitor production schedules, allocate resources, and adjust plans to meet targets.
- Provide on-the-job training, coaching, and mentorship to manufacturing operators and production service associates.
- Troubleshoot production and equipment issues and escalate when required.
- Lead batch readiness activities including planning, material requests and transfers, and staging of materials and equipment.
- Ensure all activities comply with cGMP and FDA regulations and company procedures.
- Enforce SOPs and quality standards and review GMP records for completeness and accuracy daily.
- Identify and document deviations, assess product impact, and support corrective and preventive action proposals.
- Draft, revise, and review manufacturing SOPs, master batch records, specifications and other cGMP documentation.
- Drive process and workflow improvements and support MS&T initiatives.
- Represent the department on project teams and task forces and support continuous improvement activities.
- Maintain accurate production logs, batch records, and other manufacturing documentation.
- Maintain a clean, safe production environment and manage inventory levels for production readiness.
- Perform additional duties and flexible scheduling including weekend work as needed.
- Bachelor's degree in Engineering, Science, or related field or equivalent experience.
- Minimum 2 to 3 years of leadership experience in pharmaceutical manufacturing or a CDMO environment with hands-on manufacturing or validation experience.
- Strong knowledge of cGMP guidelines, FDA regulations, cleanrooms, HVAC systems, pharmaceutical processing, and plant equipment.
- Demonstrated experience with aseptic handling and biosafety cabinet operations.
- Proficiency with single-use technologies including tube welding and sealing.
- Excellent leadership, communication, problem-solving and organizational skills.
- Ability to work independently, prioritize multiple tasks, and lead cross-functional activities.
- Basic computer skills and competency with basic arithmetic.
- Degree with laboratory coursework in chemistry or biology.
- At least 2 years of cell culture experience in a cGMP biotech or pharmaceutical setting.
- Experience with mammalian cell culture processes and bioreactor operation.
- Upstream and downstream biologics experience.
- Strong technical and mechanical aptitude in bioprocessing.
- Ability to stand and walk for the length of the shift and sit or stand for extended periods.
- Frequent lifting or moving of objects up to 50 pounds.
- Ability to climb, balance, stoop, kneel, crouch, or crawl.
- Use of hands and fingers for handling and reaching.
- Visual acuity including near and far sight, color perception, peripheral vision, depth perception and focus.
FLSA: Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.