Title: Associate Director/Director, downstream process development (Biologics)– San Diego
Cellics Therapeutics is seeking an Associate Director/Director of Downstream Process Development to provide strategic, technical, and scientific leadership in process development for non-clinical, clinical, and commercial nano-therapeutics and vaccines.
Essential Duties and 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.
- Draft, review, and approve process development reports and technology transfer protocols/reports for both internal and external cGMP manufacturing facilities.
- Provide technical oversight on manufacturing batch record review.
- Author relevant regulatory submission documents (pre-IND, IND, BLA, etc.) and provide strategic guidance on regulatory interactions relating to process development and validation.
- Drive continuous improvement through technological innovation to support ongoing product development effort.
- Translate non-clinical and clinical studies demand of a new candidate biological therapeutics to development timelines and manufacturing strategy for IND and BLA.
- Provide technical support to internal and external cGMP operations.
- Doctoral (Ph.D.) degree in relevant Science with demonstrated leadership experience and subject matter expertise in biologics manufacturing process development
- 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.
- Expertise in development of in-process assays to monitor process performance preferred.
- 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.
If interested, please email a copy of your CV to firstname.lastname@example.org.