Associate Director/Director Fill-Finish and Packaging

Our client is looking for a seasoned Associate Director/Director, Fill Finish and Packaging. The biopharma client is located in the East Bay (San Francisco Bay Area). They are a division of a larger company with an exciting state-of-the-art biologics manufacturing facility. They were recently acquired by a larger company, and while they have 2 novel compounds, their strategic plan includes using this West Coast facility to augment them as a leading Contract Development and Manufacturing Organization (CDMO) specializing in the development and manufacturing of biologics, particularly antibodies. The role would be on-site, 5 days a week and reports to the Chief Manufacturing Officer. Please do not apply if you cannot be on-site in the SF Bay Area. Highlights Direct/manage daily operations for 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. 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. 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. 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. Requirements Biotech or pharmaceutical industry experience required. BS or MS Degree or higher in Engineering (preferred) or another scientific discipline. 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. 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. More information and an updated Job Description will be available for qualified candidates. Salary is competitive and is being finalized. All resumes should be sent to Vivente Corporate Search. All cover letters are welcome with your application or email cover letter only to View email address on click.appcast.io (be sure to apply on LinkedIn as well). Thank you. #J-18808-Ljbffr Vivente Corporate Search