About Us: ASC Therapeutics is an independent, fully incorporated biopharmaceutical company with dedicated scientists and industry veterans with a strong belief in gene and cell therapy, the future for treating rare disease. We provide dynamic and people-oriented work environment, where you can learn about cutting-edge technology in gene therapy. Your contributions will also be greatly recognized by the company.
Job Title: Director, Gene and Cell Therapy
Location: Milpitas, CA
Expected hours of work: 40
Reports to: Sr VP, Global Operations
Supervisory responsibilities: CMC Associates/Scientists
Department interactions:
Will work cross-functionally with Discovery, Therapeutic Development, Clinical Development, Regulatory Affairs, Quality, HR, IT, Finance, and external CDMOs
Job Objective:
ASC Therapeutics is dedicated to bringing therapies for unmet medical needs to patients. In doing so each function in ASC Therapeutics is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life (i) by living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.
Reporting to the Sr. VP of Global Operations, the Director of Gene and Cell therapy will be responsible for drug substance and drug product process development, manufacturing and supply chain for gene and cell therapies activities for all phases of clinical development and commercialization for all ASC Therapeutics programs.
These activities can be carried out either in-house or by outsourcing to contract development & manufacturing organizations (CDMO). The candidate will serve as the primary liaison with relevant functions at ASCTx, especially Quality, Therapeutic Development, Clinical and Regulatory.
A key objective of the Global Operations department is to ensure timely and cost-effective processes as well as high quality standards for all activities and documentation efforts (development reports, batch records, regulatory dossiers, data trending, etc). In addition to having advanced skills in technical aspects related to scale up and manufacturing, the role requires exceptional leadership, hands-on, organizational, collaboration, and communication skills.
The position will also assist in developing documents and maintaining compliance consistent with GLP and cGMP standards for pre-clinical, early and late-stage clinical development from pre-IND meeting through Phase 3 clinical development and supporting regulatory submissions leading to commercialization.
Job Summary
Establish and oversee the implementation of the overall global operations strategy for all products in development stages ranging from preclinical GLP studies through early and late phase clinical trials as well as commercialization.
- Lead and oversee the development, tech transfer, automation and qualification of manufacturing processes developed and executed at CDMOs for use in GLP non-clinical and cGMP clinical development.
- Lead and oversee the sourcing, management and distribution of manufacturing equipment, APIs, excipients, and pharmaceutical packaging.
- Lead and oversee SOPs, IQO Protocols/Reports, BPRs and Specifications for Pharmaceutical Development and Manufacturing activities.
- Analyze and summarize complex data sets, including the use of appropriate statistical tools for the identification of CPPs and CQAs, development of drug product specifications and shelf-life estimates for drug product formulations.
- Review CMC project plans and timelines and assist in execution to ensure all projects are appropriately prioritized and key goals are met on time.
- Develop and maintain an in-depth knowledge of drug product manufacturing and development technology, and the associated regulatory requirements.
- Author and review CMC regulatory submissions.
- Effectively work within the Development department and cross-functional team leaders to achieve corporate and program goals.
- Develop drug product supply strategy, timelines, and risk mitigation strategies for all process development and manufacturing campaigns for early development through NDA.
- Develop in-process control strategies, normal operating and proven acceptable ranges, starting material, intermediate and drug substance specifications based on sound scientific and regulatory principles.
- As the principal internal technical subject matter expert (SME), lead technology transfers, scale-up, validation, and problem-solving activities during all stages of drug substance manufacturing.
- Evaluate and select appropriate CDMOs for project specific development activities, as needed.
- Author/review and approve batch records for drug substance manufacturing, process development reports and IP applications.
- Represent the CMC Team at internal and external scientific team meetings to provide project relevant updates and guidance.
Minimal Requirements
- Bachelor’s degree in relevant field to the job specs
- 5+ years of experience in biotech process development or manufacturing
- Extensive experience in the manufacture of cGMP drug substances and drug products
- Good communication skills at individual, team, and organizational levels
- Strong people management skills
- Strong technical and analytical skill
- Experience working in a team environment, facilitating a team approach, and communicating effectively
- Ability to plan and manage budgets
Preferred Backgrounds
- College degree in chemistry, pharmaceutics, materials science, chemical engineer or relevant discipline with 10+ years of experience in pharmaceutical or biotechnology process development and/or manufacturing
- Broad understanding of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies, distribution across multiple regions
- Managing external CDMO’s a plus
- Strong leadership skills, ability to drive accountability, compliance, and efficiency throughout the department
- Ability to cope with many topics in parallel, to cope with strict timelines and to handle pressure
- Team player and the ability to influence others