Description

Agenus Biologics is a mid to late-stage IO company developing and manufacturing antibodies for cancer treatment of patients with unmet need through commercialization. The state-of-the-art biologics 83,000sf 6455 Christie facility in Emeryville has end-to-end capabilities. The 3-floor building consists of offices, laboratories, drug substance and drug product manufacturing suites including fill/finish, packaging/labeling, warehousing, and distribution spaces. The facility will operate 24/7 producing antibodies for clinical and commercial supply.

We currently have an exciting opportunity available for an Associate Director/Dir, Fill/Finish and Packaging in Emeryville CA

The incumbent will direct/manage daily operations pertaining to all aspects of clinical and commercial fill/finish and packaging operations including process development, process optimization, technical document authoring, continuous improvement, process validation, continuous process verification, routine problem resolving, troubleshooting, and scheduling production. This role will be the technical and leadership resource for fill-finish manufacturing to interface with RA, QA, QC, FAC, VAL, PD, SC, and drug substance production teams. This position will report to the Chief Manufacturing Officer and will be based in Emeryville, CA.

ESSENTIALS OF THE JOB

• Direct the work of fill-finish manufacturing personnel in the aseptic filling and product labeling, packaging, and serialization.
• Establish and maintain quality processes within fill-finish operations
• Develop or revise procedures as needed in conjunction with the Quality department for filling and finishing. Ensure proper documentation, procedures, and batch records, improve quality, and fill-finish manufacturing efficiency.
• Establish weekly production schedules to ensure orders and product specifications are met.
• Direct validation efforts, interacting with Quality Control Directors, Technical Operations, Manufacturing, and Quality Assurance.
• Develop more efficient methodologies for departmental operations.
• Respond to reports from internal/external audits.
• Assign and supervise change controls or deviation reports as needed.
• Review statistical data with Scientific and Technical Operations, based upon trends and development work, modify procedures using the change control and process validation systems for the goal of optimum yields and productivity.
• Assure compliance with GMP including training, documentation, and processes.
• Interact with the management of Supply Chain, Manufacturing, Quality and Technical Operations to establish production schedules and protocols and provide input into new fill/finish facility/equipment operation, and upgrades.
• Assist in preparation of Biological License Application for a new product.
• Participate in pre-approval FDA inspection and comply with audit reports.
• Support product life cycle management strategies and associated regulatory submissions.

Qualifications

Education Requirements:

BS or MS Degree or higher in Engineering (preferred) or another scientific discipline.

Experience Requirements:

Eight or more years directing/managing an aseptic filling operation (required) and or Packaging/labeling. Experience with automated filling equipment such as the Vanrx SA-25 is preferred.

Other Essential Knowledge:

Knowledge of GMPs and all aseptic filling and finishing equipment. Good knowledge and experience with DSCSA and biologics labeling design is necessary. Good knowledge of FDA, EU, JP Monograph, and other health authority regulations is required. Good experience and understanding of regulatory site inspections for a commercial fill/finish facility is preferred. Good interpersonal skills. Intermediate proficiency in quality document systems, word processing, and spreadsheet packages.

The targeted salary range for this position is $145,000 - $186,300 per year. Agenus is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offered is commensurate with Agenus’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, critical needs of the role, and internal equity.