Director/Sr. Director, Downstream Process Development (San Diego)
Cellics Therapeutics, Inc., San Diego, California, United States, 92189
About the Company
Cellics Therapeutics is a rapidly growing biotech company developing novel therapeutics for inflammatory and infectious diseases based on the award-winning Cellular Nanoparticle technology. Cellics offers a highly motivational and rewarding work environment with attractive salary and benefits.
About the Role Cellics Therapeutics is seeking a Director/Sr. Director of Downstream Process Development and Manufacturing to provide strategic, technical, and scientific leadership in process development and GMP Manufacturing for non-clinical, clinical, and commercial nano-therapeutics and vaccines.
Responsibilities Lead the design and execution of phase-appropriate process development, technology transfer, process characterization and validation associated with the implementation of cGMP-compliant manufacturing processes and systems for novel nano-therapeutics and vaccines from the development stage to commercialization. Identify and control critical process parameters (CPPs) and critical quality attributes (CQAs) across cell handling, nanoparticle synthesis, coating, purification, and fill/finish. Design robust, reproducible processes that minimize operator dependence and variability. Support deviation investigations, root cause analyses, and CAPAs related to process issues. Own CMC strategy for IND and subsequent regulatory submissions. Ensure processes, controls, and documentation are suitable for FDA review. Define manufacturing requirements, batch records, and process controls. Partner with Regulatory Affairs and author relevant regulatory submission documents (pre-IND, IND, BLA, etc.) and provide strategic guidance on regulatory interactions relating to process development and validation. Translate non-clinical and clinical study demands of new candidate biological therapeutics to development timelines and manufacturing strategy for IND and BLA. Drive continuous improvement through technological innovation to support ongoing product development effort. Draft, review, and approve process development reports and technology transfer protocols/reports for both internal and external cGMP manufacturing facilities. Evaluate, select, and manage CDMO partners. Provide technical support to internal and external cGMP operations.
Qualifications Doctoral (Ph.D.) degree in relevant Science/Engineering/Biotechnology with demonstrated leadership experience and subject matter expertise in biologics process development and GMP manufacturing. At least 10 years of experience in a biotech or pharmaceutical organization. Hands-on experience with nanoparticle fabrication processes, purification processes, and microfluidization processes highly desired. Deep and broad knowledge of relevant cGMPs, ICH guidelines, and QBD principles. Experience with process development of biologics therapy in various stages of development (preclinical to commercialization). Experience in technology transfer including transitioning of research process into cGMP process and transferring existing or new process to internal and external manufacturing facilities. Experience in preparing and updating regulatory filings (IND, BLA). Demonstrated experience in building and leading exceptional teams. Leadership qualities of the successful candidate include the following: developing high performing teams, cross functional engagement and influence, collaboration, and strategic vision. Ability to manage multiple projects, prioritize objectives, and manage resources to achieve established deadlines.
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About the Role Cellics Therapeutics is seeking a Director/Sr. Director of Downstream Process Development and Manufacturing to provide strategic, technical, and scientific leadership in process development and GMP Manufacturing for non-clinical, clinical, and commercial nano-therapeutics and vaccines.
Responsibilities Lead the design and execution of phase-appropriate process development, technology transfer, process characterization and validation associated with the implementation of cGMP-compliant manufacturing processes and systems for novel nano-therapeutics and vaccines from the development stage to commercialization. Identify and control critical process parameters (CPPs) and critical quality attributes (CQAs) across cell handling, nanoparticle synthesis, coating, purification, and fill/finish. Design robust, reproducible processes that minimize operator dependence and variability. Support deviation investigations, root cause analyses, and CAPAs related to process issues. Own CMC strategy for IND and subsequent regulatory submissions. Ensure processes, controls, and documentation are suitable for FDA review. Define manufacturing requirements, batch records, and process controls. Partner with Regulatory Affairs and author relevant regulatory submission documents (pre-IND, IND, BLA, etc.) and provide strategic guidance on regulatory interactions relating to process development and validation. Translate non-clinical and clinical study demands of new candidate biological therapeutics to development timelines and manufacturing strategy for IND and BLA. Drive continuous improvement through technological innovation to support ongoing product development effort. Draft, review, and approve process development reports and technology transfer protocols/reports for both internal and external cGMP manufacturing facilities. Evaluate, select, and manage CDMO partners. Provide technical support to internal and external cGMP operations.
Qualifications Doctoral (Ph.D.) degree in relevant Science/Engineering/Biotechnology with demonstrated leadership experience and subject matter expertise in biologics process development and GMP manufacturing. At least 10 years of experience in a biotech or pharmaceutical organization. Hands-on experience with nanoparticle fabrication processes, purification processes, and microfluidization processes highly desired. Deep and broad knowledge of relevant cGMPs, ICH guidelines, and QBD principles. Experience with process development of biologics therapy in various stages of development (preclinical to commercialization). Experience in technology transfer including transitioning of research process into cGMP process and transferring existing or new process to internal and external manufacturing facilities. Experience in preparing and updating regulatory filings (IND, BLA). Demonstrated experience in building and leading exceptional teams. Leadership qualities of the successful candidate include the following: developing high performing teams, cross functional engagement and influence, collaboration, and strategic vision. Ability to manage multiple projects, prioritize objectives, and manage resources to achieve established deadlines.
**Please, no search firms.