Supervisor, Aseptic Manufacturing

Iovance Biotherapeutics•Philadelphia, PA

4d•Onsite

About The Position

The Supervisor for Aseptic Manufacturing oversees production to ensure materials are produced safely and according to company standards, documents are reviewed promptly, and targets are met. The role develops staff, implements a “First-time right” program, onboards new team members, and manages deviations and CAPAs for the training and learning team. As a leadership team member in autologous cell therapy manufacturing, the supervisor contributes technical expertise and oversees manufacturing operations in a setting where cell culture and ISO Class 5 cleanroom experience are necessary. The role follows a two-week rotation: Week 1, Shift A is Sunday to Wednesday, 0700–1830; Week 2, Shift A is Sunday to Tuesday, 0700–1930. Travel is 10%. The position works in both office and manufacturing settings, including cleanrooms, and involves exposure to biohazards, human blood components, chemicals, and other manufacturing-related conditions.

Requirements

Minimum bachelor’s degree in biology, biochemistry, bioengineering, or a related technical field, or equivalent industry and technical experience.
Minimum 5 years of experience in biopharmaceutical GMP manufacturing operations, including cell culture and associated downstream processing.
Demonstrated technical knowledge of aseptic processing in cleanroom environments.
Strong knowledge and experience of the end-to-end learning process, including learning needs assessment, program design and delivery, learning evaluation, and training-effectiveness assessment.
Strong oral and written communication skills; ability to contribute to training, report generation, and documentation, with strong technical writing ability.
Ability to lead development initiatives, including training, coaching, and learning initiatives.
Ability to mentor team members and provide best practices.
Ability to build relationships quickly and credibly, support staff, and manage and influence large manufacturing teams, potentially 50 or more employees, with varied personalities and experience levels.
Proactive, results-oriented self-starter with demonstrated leadership skills and experience in a complex manufacturing environment.
Ability to adapt plans quickly and manage ambiguity and constant change.
Ability to work successfully in a fast-paced, team-oriented environment.
Quality mindset and familiarity with 21 CFR Part 11, standard GxP best practices, and FDA regulations.
Remain current with cGMP guidelines and develop or modify production methods to fully address compliance issues.
Able to wear cleanroom attire and required PPE, including scrubs, gowning coveralls, masks, and gloves.
Meet requirements for and be able to wear a half-face respirator.
Able to stand or walk 90% and sit 10% of the scheduled workday, including potentially climbing ladders or steps.
Able to crouch, bend, twist, reach, and perform repetitive motions.
Able to lift and carry objects weighing 45 pounds.
For the Visual Inspection Program, must not be color blind and must have 20/20 near vision in both eyes, correctable if needed.
Able to meet the role’s mental demands, including conceptual thinking, judgment, troubleshooting, problem-solving, analysis, discretion, handling work-related stress, managing multiple priorities, and meeting deadlines.

Nice To Haves

At least 2 years in a lead, leadership, or supervisory role is desired.

Responsibilities

Supervise and develop direct-report operators, mentoring and coaching staff and peers to foster continuous improvement and operational excellence.
Schedule and coordinate day-to-day activities to ensure conformance with the daily schedule.
Develop subject-matter expertise in the assigned production area and apply knowledge of aseptic processing and cGMP regulatory requirements.
Oversee manufacturing processes to ensure technicians follow cGMP practices and proper aseptic techniques.
Review batch documentation and logbooks for completeness and accuracy.
Work under limited supervision and address complex problems.
Identify and support approaches, practices, and processes that improve operational efficiency and efficacy.
Establish objectives, conduct performance reviews, monitor progress toward goals, and provide timely feedback to management.
Author and revise documentation, including SOPs, batch records, deviations, and CAPAs.
Ensure the department understands and complies with quality standards and requirements.
Ensure efficient operations and compliance with cGMPs and safety regulations.
Work in a cleanroom environment involving biohazards, human blood components, and chemicals.
Comply with company values, policies, procedures, business ethics, Safety SOPs, SDS sheets, laboratory procedures, and OSHA regulations.
Perform miscellaneous duties as assigned.
Travel as required (10%).