Cellics Therapeutics, Inc. · 3 weeks ago
Director/Sr. Director, Downstream Process Development
San Diego, CA
Full-time
Onsite
Director/Executive
$160K/yr - $230K/yr
10+ years expCellics Therapeutics is a rapidly growing biotech company developing novel therapeutics for inflammatory and infectious diseases. They are 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 nano-therapeutics and vaccines.
BiotechnologyHealth CareTherapeutics
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
Qualification
Required
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
Benefits
Attractive salary and benefits
Company
Cellics Therapeutics, Inc.
Cellics has developed a novel, proprietary, first-in-class therapeutic platform to address the complex biology of significant unmet medical needs in Inflammation and Immunology.
11-50 employees
H1B Sponsorship
Cellics Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (2)
Funding
Current Stage
Growth StageTotal Funding
$36.94MKey Investors
CARB-X
2022-02-17Series B· $7M
2020-10-21Grant· $3.94M
2020-05-26Series Unknown· $13M
Leadership Team
Paul Daruwala
President & CEO at Cellics Therapeutics
Company data provided by crunchbase