Reporting to the Sr. Vice President of Process Development and Manufacturing, the Director / Senior Director, Chemistry Manufacturing and Controls will work closely with project teams and cross-functional teams in planning, budgeting, overseeing manufacturing activities in external CMOs, as well as integrating, tracking and communicating CMC activities for the Apollomics’ product development programs. Key responsibilities and knowledge and skills for the position are listed below.
- Lead the identification, selection and management of Contract Manufacturing Organizations (CMOs) for process development, process optimization, cGMP manufacture and supply of Drug Substance (API) and Drug Product (DP) in support of Apollomicsclinical development programs.
- Drug Substance: Synthetic route evaluation/selection, CMO site selection, process development, optimization and scale-up.
- Drug Product: pre-formulation characterization, development of phase appropriate dosage formulations/configuration, process optimization and scale-up.
- Analytical: phase appropriate method development and qualification/validation, develop appropriate specifications for drug substances and drug products – provide guidance for establishing appropriate stability programs to support desired retest and expiry dating of drug substance and drug product.
- Ensure delivery of robust, scalable and cost-effective manufacturing routes and drug product formulations that meet target product profile.
- Provide strategic guidance in development, optimization, characterization and validation of product and process parameters in a time and cost-sensitive manner from early to late stage development program toward preparation of pivotal clinical drug supply and commercialization
- Lead the formulation design/development for Apollomicsclinical programs.
- In conjunction with Clinical Operations, actively manage the supply chain and logistics in support of clinical studies.
- Communicate strategy and project status to cross-functional stakeholders and assist in driving decision making. Prepare technical reports, publications and presentations.
- Identify and monitor critical path activities of vendors and develop contingency plans when the project deviates from that path.
- Oversee or act as technical lead in development projects and ensure execution of plans and program objectives.
- Interact with cross-discipline personnel to integrate technical information across project activities, specifically communication of CMC-related topics.
- Interface with Regulatory Affairs to communicate CMC topics for regulatory submissions.
- Develop budgets and resource planning to achieve product development goals.
- Writing and reviewing documents for INDs /NDA regulatory section submissions; represent APOLLOMICS as the CMC expert before U.S., European, China and ROW regulatory authorities.
- Prepare, review and/or edit cGMP batch records, CMC regulatory and Quality documents.
- Preferably a Ph.D. (minimum Master’s Degree) in chemistry, chemical engineering, or related discipline with a deep understanding of industry scale small molecule synthetic chemistry and demonstrable expertise in pharmaceutical CMC development, process scale-up and cGMP manufacturing and supply chain management.
- Ideally 15+ years of process chemistry/analytical development and drug manufacturing experience with a strong track record of scientific/technical/strategic leadership on managing CMC teams and overall delivery for successful advancement of clinical development.Experience on late stage CMC development and commercialization will be favorably considered.
- Track records and first-hand knowledge in biologic CMC management will be preferred.
- Thorough understanding and experience of CMC considerations with respect to GMP, quality systems, FDA and associated regulatory requirements, specifically late stage IND, Quality Amendment and NDA.
- Familiarity with global quality requirements and the US/EU/China and international regulatory guidance and processes including experience with Regulatory Affairs CMC requirements and expectations, including writing related submissions.
- Innovative team-player with high energy for a dynamic company environment. Collaborate effectively with clinical, quality, cross-functional team members and external partners.
- Outstanding communication skills (verbal and written). Reading and writing Mandarin Chinese is a plus.
- Attention to detail and ability to organize and prioritize tasks in a timely and accurate manner.
- Ability to work and manage multiple projects collaboratively in a fast-paced dynamic environment.
- Understanding of the pharmaceutical culture and the special requirements of completing projects within a regulated environment.
Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of oncology combination therapies that harness the immune system and target specific molecular pathways to eradicate cancer globally. The company’s existing pipeline consists of five development-stage assets including two novel, humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and three targeted therapies against uncontrolled growth signaling pathways.