Director of Manufacturing-Biotech
This position will be responsible for the following:
- Responsible for the facility, system and production readiness to manufacture pre-clinical and clinical grade material;
- Provide leadership to ensure all GMP required validation is preformed for products, process, equipment and facilities to support the company's regulatory licensing requirements;
- Coordinate, develop and implement cGMP systems and procedures including equipment SOPs, operational SOPs and Batch Production Records;
- Participate with Research & Development Teams to ensure new cell products can be transferred, commercially scaled-up and validated to meet regulatory operational requirements;
- Develop manufacturing operating budget and manage areas of responsibility within approved budget.
- Generate manufacturing production schedule (MPS) to ensure that product inventory is maintained to meet clinical and partner needs.
- Participate in writing the operations portions of the CMC section of regulatory submissions (IND, NDA, etc.).
- Participate as the primary manufacturing representative for regulatory, partner, and investor audits.
- Provide leadership in the development of commercial manufacturing plan and participate in its approval by the FDA.
- Participate in facility tenant improvement (TI) and/or Tech Transfer activities within SCT or outside to partner, distributor, investor facilities;
- Interview and make recommendations for hiring new employees as needed;
- Form, develop, and coach a Manufacturing team in a cGMP-compliant cell therapy Manufacturing Facility. Oversee daily Manufacturing personnel activities, overall job performance and long-term professional growth;
- Oversight of aseptic process simulation (APS) or media run program. Ensure process, facility and personnel are in a state of qualification to perform routine GMP manufacturing;
- Establish training requirements for Manufacturing personnel, ensure timely completion and proper documentation of training;
- Ensure that manufacturing staff adhere to all EH&S policies, procedures and guidelines;
- Troubleshooting cell therapy manufacturing processes to maximize product yield and quality
- Responsible for final review and approval of completed manufacturing batch documentation, including the generation and disposition of deviations, OOS, and OOTN events;
- Partner with Quality to perform manufacturing investigations as required;
- Keep management informed about team operations, projects and production on a regular basis;
This person manages the manufacturing department. Responsible for regular 1:1 meetings, performance coaching/counseling as required, career development, time sheet management and annual performance reviews.
Education and Experience:
- BS in biological sciences, at least 15 years of cell manufacturing experience.
- 5-7 years of managerial experience.
- Thorough knowledge of current Good Manufacturing Practices and aseptic processing guidelines (APS) as they relate to the production of cell therapy products for human clinical trials.
- Experience in taking manufacturing through clinical trial phases and developing commercial manufacturing capabilities for phase III production, PAI readiness and routine cGMP manufacturing.
- Ability to create and support an environment that encourages employee involvement.
- Excellent interpersonal skills.
- Excellent written and oral communication skills.
- Ability to make timely decisions based on logical assumptions and factual information.
- Knowledge of basic computer skills required to operate Microsoft office suite.
- May be required on occasion to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing.
- Must be able to work around bio-hazardous materials and chemicals such alcohol, acids, and/or buffers if required.
- This position is generally managerial in nature, however, the maybe requirements to physically work in PD or MFG if required. For these situations individual must;
- Be able to lift, push, pull and/or carry up to 25 lbs.
- Be able to sit or stand for long periods of time. Regularly required to sit, stand, walk, climb, stoop, kneel, crouch; use hands to handle or feel; and reach with arms.
Note: This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job which may include other duties as assumed or assigned.