ImmunityBio (formerly NantCell) develops novel combinations of chemo-immune sensitizers, cell therapies, cytokines, vaccines, neoepitopes, and monoclonal antibody immunotherapies to orchestrate the NK and T Cell response for cancer and infectious diseases.
Supervisor, Manufacturing - Downstream
PURPOSE AND SCOPE OF POSITION
The candidate will be responsible for the supervision of all downstream Purification day-to-day floor manufacturing operations as well as all preparation activities on and off the manufacturing floor. The candidate will also participate in cross-functional projects with Product Development (PD) and Process Engineering (PE) to develop, scale-up, and transfer new products.
DUTIES AND RESPONSIBILITIES
- Performs manufacturing activities according to Current Good Manufacturing Practices (cGMP) guidelines, including batch record execution, product and equipment changeover, manufacturing equipment troubleshooting, and issue resolution.
- Execute process operations in accordance with a dynamic production timeline.
- Develop or assist in developing a Purification operational schedule based on complete adherence to organizational time-lines.
- Ensures safety and cGMP compliance in the manufacturing area at all times.
- Communicate transparently with management.
- Ensure staff is trained and proficient to perform all aspects of Purification operations in accordance with cGMPs, including but not limited to:
- Clarification and Filtration
- Column Chromatography
- ÄKTA and Unicorn control system
- Final Formulation and Filtration
- Drug Product vial filling
- Develop and author necessary supporting cGMP documentation that supports all Purification manufacturing processes and operations above, including but not limited to:
- Equipment Use Logs
- Standard Operating Procedures (SOPs)
- Batch Production Records
- Raw Material Specifications
- Deviation Reports
- Author CAPA reports and drives implementation of actions according to the mandated timelines agreed upon in conjunction with the Quality Assurance group.
- Successfully maintain aseptic gowning qualification status and participate in annual media fills.
- Attend and drive value-added meetings as necessary.
- Mentor, train, and develop Manufacturing Associates.
- Cross-train on and assist with Upstream operations as required.
- Effectively engage cross-functionally with other departments in order to streamline all operations supporting cGMP manufacturing.
- Communicate and facilitate effectively with external groups as applicable to support team success.
- Develop and contribute process improvement initiatives with all Purification manufacturing equipment and operations.
- Assist or execute the ordering of material and ensure that equipment and materials are available for production runs.
- Assist with On-The-Job (OJT) training of new Purification manufacturing operators.
- Maintain current on all cGMP requirements.
- Maintain and sustain all organizational training profile requirements.
REQUIRED COMPETENCIES (KNOWLEDGE, SKILLS, AND EXPERIENCE)
- MS with 2-5 years, or BS with 5-8 years of cGMP Biopharmaceutical manufacturing industry experience in multi-product facilities.
- Prior experience in manufacturing is required.
- Prior hands‐on experience with chromatography systems, such as AKTA process skids, is required.
- Experience in clinical and/or commercial‐scale production operations subject to cGMP regulations.
- Strong interpersonal skills, a collaborator and team player, inclusive to the diverse opinions of others.
- Fluency with MS Office (Word/Excel/PowerPoint/Project/Visio/OneNote).
- Excellent oral and written communication skills.
- Must be a self-starter and highly motivated.
- Ability to multitask projects simultaneously, and prioritize projects.
- Must have the ability to perform work while wearing the appropriate gowning material for cleanroom environments and work under aseptic conditions in a class 100 environment (BSC).
- Ability to work weekends occasionally to support the dynamic production schedule and relevant timelines.
- Ability to occasionally work extended shift hours to support the dynamic production schedule and relevant timelines.
- Must have the ability to manage up to fifty (50) pounds at a time and stand for extended periods of time while wearing appropriate cleanroom gowning material and appropriate personal protective equipment is required.