Clinical Stage Biotechnology company is hiring a Director, Downstream Process Development to help advance the organization's lead program to commercial launch. You will develop Process Development team, optimize purification processes, lead various late-stage initiatives, process characterization, and author regulatory filings. You will have strong technical background knowledge of downstream operations, including various filtration and chromatographic operations. Additionally, you will oversee the management of both internal teams and external CDMOs.
Responsibilities
Lead the Process Development group to develop globally compliant, robust, well-characterized, scalable and high quality AAV production platform to support both internal and external (CDMO) manufacturing requirements for clinical and commercial programs.
Lead process characterization/validation studies (including FMEA, scale-down model establishment and DOE/OFAT approach to identify critical process parameters) and process performance qualification, including review of development, manufacturing, process characterization and validation protocols and reports.
Oversees the development and implementation of an process monitoring/control strategy program using appropriate statistical guidelines.
Technical management of development operations at Contract Development and Manufacturing Organization (CDMOs).
Collaborate and work cross-functionally with Manufacturing, Regulatory Affairs, Assay Development, Finance, and Quality functions to ensure all activities are scheduled and executed on time in accordance with program timelines.
Identify, evaluate, and implement novel technologies and systems in the development of manufacturing platforms.
Build and maintain collaborative working relationships with CMOs, including managing contracts.
Serve as subject matter expert and provide technical expertise to process related troubleshooting, and Quality support.
Support authoring efforts for specific CMC sections of regulatory filings (including INDs, comparability packages, BLA's, and formal responses to regulatory inquiries).
Qualifications
Ph.D. in biochemical engineering, biochemistry, or appropriate technical discipline with 8+ years (MS with 10+ years) of industrial bioprocess development experience.
Demonstrated experience with track record of success leading technical teams, experience in process scale-up and development of scale-down models.
Must-have advanced knowledge of DOE principles, process characterization, and BLA submission.
Proven leadership experience and strong people management skills with the desire and ability to deliver on objectives while developing people in a dynamic and fast-paced environment.
Broad experience in cGMP biologics manufacturing and understanding of regulatory guidelines.
Strong background and subject matter expertise in purification unit operations including column chromatography, filtration (TFF), harvest and viral clearance validation. Upstream (cell culture, bioreactor) experience is a plus.
Salary:
$201,000-$225,000
R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.