Supervisor, Aseptic Manufacturing

Iovance Biotherapeutics•Philadelphia, PA

3d•Onsite

About The Position

The Supervisor for Aseptic Manufacturing oversees production to ensure materials are produced safely and in accordance with company standards, reviews documentation promptly, and supports achievement of production targets. The role develops staff, implements a “First-time right” program, helps onboard new team members, and manages deviations and CAPAs related to the training and learning team. As a leadership team member in autologous cell therapy manufacturing operations, the supervisor serves as a subject matter expert for a production area and contributes technical expertise to manufacturing operations. The position supervises and develops operators, coordinates daily activities, oversees adherence to cGMP and aseptic practices, reviews batch records and logbooks, and authors or revises quality and manufacturing documentation. It also supports training and learning initiatives, staff performance and development, operational improvement, and compliance with quality and safety requirements. Work takes place in both office and manufacturing settings, including cleanrooms with biohazards, human blood components, chemicals, and other manufacturing-related hazards. Travel is 10%. Schedule rotation: Week 1, Shift A runs Sunday to Wednesday, 0700–1830. Week 2, Shift A runs Sunday to Tuesday, 0700–1930.

Requirements

Minimum B.S. in biology, biochemistry, bioengineering, or a related technical field, or equivalent industry and technical experience.
Minimum of 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 of the end-to-end learning process, including needs assessment, program design and delivery, learning evaluation, and training-effectiveness assessment.
Strong oral and written communication skills, including contributions to training, report generation, and documentation such as batch records and deviations.
Strong technical writing ability.
Ability to lead development initiatives involving training, coaching, and learning.
Ability to mentor team members and provide best practices.
Ability to build relationships quickly and credibly and provide consistent support to staff.
Ability to manage and influence large teams in a manufacturing environment, potentially 50 or more employees, with varied personalities and experience levels.
Proactive, results-oriented, self-starting approach and demonstrated leadership skills in a complex manufacturing environment.
Ability to handle ambiguity, adapt plans quickly, and manage constant change.
Ability to work successfully in a fast-paced, team-oriented environment.
Quality mindset and familiarity with 21 CFR Part 11, GxP best practices, and FDA regulations.
Ability to remain current with cGMP guidelines and develop or modify production methods to address compliance issues.
Ability to work under limited supervision and handle complex problems.
Ability to work in a cleanroom with biohazards, human blood components, and chemicals.
For the Visual Inspection Program, the technician must not be color blind and must have 20/20 near vision in both eyes, correctable if needed.
Ability to wear cleanroom attire and required PPE, including scrubs, gowning coveralls, masks, and gloves.
Ability to meet requirements for and wear a half-face respirator.
Ability to stand or walk 90% and sit 10% of the scheduled workday, including potentially climbing ladders or steps.
Ability to crouch, bend, twist, reach, and perform repetitive motions.
Ability to lift and carry objects weighing 45 pounds.
Clear and conceptual thinking, sound judgment, troubleshooting, problem-solving, analysis, and discretion.
Ability to handle work-related stress, manage multiple priorities, and meet deadlines.

Nice To Haves

A minimum of 2 years in a lead, leadership, or supervisory role is desired.

Responsibilities

Supervise and develop direct reports, including mentoring and coaching operators and staff to promote continuous improvement and operational excellence.
Schedule and coordinate day-to-day activities and ensure conformance to the daily production schedule.
Develop a comprehensive understanding of the production process and serve as a subject matter expert in a specific area.
Oversee manufacturing activities and ensure technicians follow cGMP practices and appropriate aseptic techniques.
Review batch documentation and logbooks for completeness and accuracy.
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 documented quality standards and requirements.
Ensure efficient operations and compliance with cGMPs and safety regulations.
Support onboarding and training and manage deviations and CAPAs for the training and learning team.
Comply with company values, policies, procedures, business ethics, safety SOPs, SDS sheets, laboratory procedures, and OSHA regulations.
Perform miscellaneous duties as assigned.