- Lead production team for viral vector and cell therapy Current Good Manufacturing Practices manufacturing (cGMP) and cGMP supply chain.
- Ensure timely onboarding of personnel to maximize training opportunities and to deliver all process and/or facility validation requirements.
- Work with site teams to integrate with and influence established site systems as needed to implement new vector and cell therapy production operations.
- Create visibility to site integration activities and/or gaps and establish processes for site integration with production operations (or vice versa).
- Lead all manufacturing aspects of tech transfer into manufacturing including, but not limited to, assessment of new product requirements against processes, generation of product specific documentation, supporting the introduction of new equipment, raw materials and/or consumables, determine safety implications if any and training of personnel.
- Lead qualification of processes as needed for production and to ensure readiness for product introduction.
- Develop manufacturing area plan and systems/processes that support both the project and operationalizing the manufacturing facility.
- Manage manufacturing activities for viral vector and cell therapy, including cGMP aseptic qualification, in support of manufacturing and formulation of viral vectors as drug substance and of cell therapeutics as drug products.
- Adhere to clinical and launch supply chain targets by meeting or exceeding monthly and annual production output demand.
- Demonstrate commitment to safety by driving a safety culture and engaging in all safety initiatives.
- Be responsible for department cost center by reviewing monthly costs.
- Prepare and adhere to production output and operating budgets for department.
- Continuously seek opportunities for improving overall compliance and reduce discrepancies.
- Partner with Quality to implement and manage phase appropriate systems/processes/procedures to meet cGMP manufacturing requirements against regulatory standards in various regions (US/EU/etc.)
- Track adverse trends and ensure they are addressed quickly and effectively.
- Provide direction and/or act as escalation point for unresolved deviations/non conformances.
- Partner with Quality and Engineering representatives to implement effective corrective and preventative actions (CAPAs) to mitigate reoccurrence.
- Bachelor of Science and at least 10 years of experience or Master of Science and at least eight years of experience or Ph.D. and at least six years of experience.
- Manufacturing experience in biologics operations required, with viral vector and cell therapy experience much preferred.
- Highly familiar with all of the following manufacturing aspects: aseptic processing, expansion and differentiation of CAR-T products (allogenic and/or autologous), generation of viral vectors in adherent cultures, and formulation of cellular therapeutics.
- Understanding of cGMP Directives, industry guidelines and applicable agency regulation (FDA, EMA, etc.) particularly as they relate to cell and gene therapy.
- Strong leadership skills, ability to communicate and partner well with all levels of staff, to lead and motivate with emphasis on compliance and continuous improvement and to resolve conflicts.
- Ability to monitor and control processes using data trending and/or statistical process control.
- Proven ability to trouble shoot and resolve issues.
- Effectively employ all methods of communication (oral, written, presentation) to provide ongoing communication to employees or teams.
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director of manufacturing, viral vector and cell therapy - Redwood City, United States - Adicet Bio, Inc
Description
JOIN US
Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer. Adicet is advancing a pipeline of "off-the-shelf" gamma delta T cells, engineered with chimeric antigen receptors (CARs) and adaptors (CAds), to enhance selective tumor targeting and facilitate innate and adaptive anti-tumor immune response for durable activity in patients. For more information, please visit our website at
DIRECTOR OF MANUFACTURING, VIRAL VECTOR AND CELL THERAPY
Responsibilities:
Qualifications:
Adicet Bio is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting cancer.
Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, abundant, zero-cost, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company subsidized lunches (delivered onsite daily) and fully stocked breakrooms.
In compliance with California's pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open positions. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, their qualifications (education, experience, specialty, and training), and peer and market data. This listed salary range represents the Company's good faith and reasonable estimate of the range of possible compensation at the time of posting.
Pay Range$184,000—$254,000 USDAt Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting cancer.
Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, abundant, zero-cost, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company subsidized lunches (delivered onsite daily) and fully stocked breakrooms.
In compliance with California's pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open positions. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, their qualifications (education, experience, specialty, and training), and peer and market data. This listed salary range represents the Company's good faith and reasonable estimate of the range of possible compensation at the time of posting.
