Associate Director/Director Fill-Finish and Packaging

Vivente Corporate Search; San Francisco (CA); On-site; USD 230,000 - 320,000; Full time

Job summary

A leading staffing agency is seeking a seasoned Associate Director/Director for Fill Finish and Packaging in the San Francisco Bay Area. The role involves overseeing daily operations of clinical and commercial fill/finish, ensuring compliance with FDA and GMP standards, and managing a team in a state-of-the-art biologics facility. Candidates must have substantial experience in biotech and aseptic filling operations. A competitive salary package is offered, and the position requires on-site presence five days a week.

Qualifications

• Eight or more years directing/managing an aseptic filling operation.
• Knowledge of GMPs and aseptic filling/finishing equipment.
• Good experience with regulatory inspections for a commercial fill/finish facility.

Responsibilities

• Direct/manage daily operations for clinical and commercial fill/finish.
• Develop procedures in conjunction with the Quality department.
• Oversee compliance with GMP including training and documentation.
• Develop procedures and ensure proper documentation and batch records.
• Establish production schedules and support regulatory readiness.

Skills

Biotech or pharmaceutical industry experience

Good interpersonal skills

Knowledge of GMPs

Experience with automated filling equipment

Good knowledge of FDA regulations

Education

BS or MS Degree in Engineering or another scientific discipline

MS in Engineering

Tools

Automated filling equipment

Quality document systems

Job description

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 [e-mail] (be sure to apply on LinkedIn as well). Thank you.