Senior Director, Viral Vector Development and Technology
The Senior Director will provide vector process development and related CMC leadership for development of new vectors, technical support, and process improvements for AZ engineered T cell therapy products. The Senior Director will lead and accountable for vector process development and GMP Phase I to III manufacturing protocols and establishing production procedures. You will oversee a team of scientists and technical specialists responsible for vector process development and characterization and provide technical oversight to GMP manufacturing internally and at CDMOs. You will report to the Vice President, PSAT and can be performed from either Santa Monica, CA or Gaithersburg, MA location.
Role & Responsibilities
Develop strategic plans for vector process development according to organizational goals and regulatory requirements.
Lead the development of viral vector-based (e.g., lentivirus, AAV) manufacturing processes to improve efficiency, scalability, and product quality, with a focus on innovation and optimization.
Design and oversee experiments to evaluate and improve viral vector production processes, using statistical methods and experimental design principles.
Help develop budget projections, material and staffing forecasts
Manage the transfer of plasmid and viral vector processes from research and development to manufacturing, ensuring seamless integration and compliance with regulatory standards.
Ensure all process development activities comply with relevant regulatory guidelines (FDA, EMA).
Maintain rigorous quality control standards throughout the process development lifecycle.
Prepare documentation for regulatory submissions and audits.
Ensure sound design and process characterization studies to develop an understanding of late-stage Manufacturing process to support success transfer and launch of new products.
Collaborate with manufacturing teams to troubleshoot and resolve production issues.
Work with internal departments (e.g., Quality Assurance, Quality Control, Manufacturing) to align process development
Communicate project progress, challenges, and strategic plans to senior management and team members.
Stay up to date with industry trends and advancements to enhance AZ virus-related capabilities.
Lead a global team focused on viral vector process development.
Oversee a team of scientists and engineers engaged in process development activities, providing guidance, mentorship, and promoting a collaborative work environment.
Collaborate with teams and external partners to achieve common goals.
Provide mentorship and guidance to team members to foster professional growth.
Education and Experience
A minimum of twelve (12) years with BS/BA; ten (10) years with MS/MA or Eight (8) years Phd in biopharmaceutical manufacturing, technology transfer or process development experience.
Industrial experience in viral vector process development and clinical manufacturing within the biopharmaceutical industry.
In-depth knowledge of Lentiviral Vectors (LVV), Adeno-Associated Viruses (AAV), and other viral vector technologies.
Experience with cGMP regulations and compliance in a manufacturing environment.
Hands on experience in GMP operations
Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, and process development
Willing to accept temporary responsibilities outside on the list mentioned above
The annual base salary for this position ranges from $ 207,000 to $311,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).
Our Benefits:
Benefits offered include:
A qualified retirement program [401(k) plan]
Paid vacation, holidays, and paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.
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