Director, Downstream Process Development

ABOUT THE ROLE

This is a key role within our Technical Operations team as we aggressively advance our first program towards late-stage development and our second program into early-stage clinical development. This role will report to the VP of Technical Development.

The Director of Downstream Development will play a critical technical role focused on all aspects of downstream process development, scale-up from clinical to commercial scale, tech transfer of the process from one CDMO to another, operational and technical oversight of the CDMO, process troubleshooting and improvement, and generation of suitable technical data packages to support comparability assessment and eventual regulatory submissions. It is expected that the individual will also work closely with the drug product and analytical teams and, eventually, across the entire technical operations and Marea project team to support the overall development of the two programs. This role will also develop and maintain the economic model for the dowsntream process for each of our programs.

It is expected that we will operate in a very lean environment and leverage the technical resources of the CDMO in addition to consulting and advisory resources to help us achieve our CMC development goals in support of the larger program milestones. We expect this candidate to be hands-on as needed and adaptable to the evolving needs of a start-up.

 

KEY RESPONSIBILITIES

• Develop downstream process conditions with key parameters specified, leveraging the CDMO process platform adapted to our specific monoclonal antibody
• Identify, evaluate, and qualify unit operations, raw materials, equipment, sampling plan and in-process testing and overall control plans for the downstream process (Seed train, inoculum train, bioreactor and harvest) with thoughtful integration into the overall manufacturing process from seed train to final vial
• Design and oversee studies/activities necessary for process optimization and continuous improvement to assure robust and cost-effective manufacturing processes
• Provide technical oversight of the development and manufacturing activities at the CDMO
• Develop process and control strategies with an eye towards consistent and reproducible manufacturing processes and final drug substances
• Support manufacturing deviations, OOS, investigations, root cause analysis, and CAPAs, as necessary
• Manage and execute troubleshooting activities, as necessary
• Transfer manufacturing operations to new CDMOs as part of the overall project plan to ensure supply chain reliability
• Support the Drug Product Process Development group with material supply and some analytical support
• Develop technical content suitable for internal quality processes and regulatory submissions
• Contribute to preparation and review of regulatory documents for submission to FDA and other regulatory authorities
• Identify and utilize expert consultants to help address key technical questions
• Build and maintain a strong cooperative working relationship with colleagues in Drug Product, Analytical, Quality, Regulatory, Clinical Development, Project Management, and Legal
• Must have ability to travel to CDMO sites (Average upto 20 % of the time with peak needs during certain critical windows) 
• Internal laboratory work, not expected immediately, but may be needed in the future.
• Develop cost model for the downstream process

 

QUALIFICATIONS

• D. in Chemical Engineering or Microbiology, Biology or a related discipline with a minimum >8 years of relevant experience or BS/MS with >10 years of relevant experience in Biotech/Pharma industry with hands-on background and experience in downstream bioprocess development
• Specific experience with developing, scaling up, tech transferring downstream processes for CHO-derived monoclonal antibodies
• Previously experience of having worked with CDMOs with scope of work in process development, tech transfer and scale up
• Direct experience with at-scale manufacturing processes and equipment either through previous tech transfers or direct manufacturing operations experience.
• Demonstrated ability to independently write technical reports based on sound data analysis and experimental design
• Demonstrated understanding of overall drug development workflow and how CMC can enable acceleration of drug development in a cross functional environment
• Knowledge of cGMPs, especially as related to a virtual environment where manufacturing is currently outsourced to third party vendors
• Excellent professional and interpersonal skills, especially for developing and maintaining relationships with CDMO’s
• Excellent oral and written communication skills
• Ability to work efficiently and cooperatively in-person or virtually (both at Marea or a CDMO site)
• Goal oriented and ability to deliver on timelines and commitments
• Leverages the technical insights about the process and product to proactively identify critical CMC risks early and propose/implement right-sized mitigation
• Demonstrated understanding of the product attributes and analytical methods to guide process development, improvement.

 

Additional preferred qualification: While this role is focused on downstream bioprocess expertise, previous experience/familiarity with other aspects of bioprocess development (cell banking, cell culture, fiormualtio and analytical) is desired.

 

PAY RANGE

 The salary range for this role i Compensation and title will be competitive and commensurate with the candidate's experience, qualifications, and responsibilities of the position.