Director, Upstream Cell Culture Process Development and Manufacturing (Biologics)

Oruka Therapeutics - Waltham, MA

Waltham, MA

Professional, Scientific, and Technical Services

About the position

We are seeking an experienced and motivated candidate to lead early-stage IND enabling cell line and cell culture process development and manufacturing activities. In this role, the ideal candidate will be responsible for overseeing cell line and process development, tech transfer, scale-up and clinical DS manufacturing of monoclonal antibodies at the CDMOs. The successful candidate will establish CMC strategy for early-stage process development, perform gap assessment, and provide timely solutions while continuing to plan late-stage development. In this role, you will oversee activities at the CDMO partners to track and ensure timely completion of GMP drug substance manufacturing. This role involves drafting high quality reports, finalization of source documents and active participation in writing regulatory submissions. You will be an integral part of the team with an opportunity to work in a fast-paced environment.

Responsibilities

• Manage cell line development, clone selection/stability, cell banking, cell culture development, and manufacturing operations at the CDMOs for multiple programs.
• Work with the CDMO to optimize cell culture unit operations with an emphasis on robustness, scalability, quality, cost, validation with line of sight to commercial manufacturing.
• Build strong relationships and partners with other leaders across Development, Quality, Regulatory, and external CDMOs.
• Lead cell culture manufacturing with the CDMO ensuring seamless execution and timely completion.
• Manage the diligence process to select commercial DS CDMOs.
• Serve as subject matter expert and enable successful tech transfer to commercial CDMOs.
• Serve as person-in-plant (PIP) during drug substance manufacturing campaigns.
• Apply QbD principles to develop process parameters and product quality relationships to aid process optimization in support of late-stage development.
• Partner with stakeholders to support timely approval and execution of reports, batch records, in-process sampling plans, review SOPs, change controls, deviations, OOS/OOT investigations, and CAPAs.
• Support regulatory filings by authoring, reviewing, and approving technical reports, CMC sections of clinical and registration submissions (INDs/BLAs), and responses to questions.
• Perform CMC risk assessment activities in a phase appropriate manner ensuring proper measures are in place in support of production and filing requirements.
• 20-25% travel in support of manufacturing activities at the CDMOs.

Requirements

• Master's or a PhD degree in biochemistry, biochemical engineering, biotechnology or equivalent with 8-10 years of relevant experience working with biologics programs in clinical development.
• Significant experience developing cell culture processes in support of biologics manufacturing for clinical/commercial use. Direct experience with monoclonal antibodies is a must.
• Expertise in cell culture, media and bioreactor optimization with an emphasis on scale-up, scale-down models, process monitoring, facility fit and overall commercial readiness.
• In-depth knowledge of CMC, quality and compliance, as well as regulatory aspects of biopharmaceutical development and life-cycle management.
• Must have a solid understanding of unit operations, process parameters, product quality, and troubleshooting strategies enabling successful execution of phase appropriate manufacturing campaigns.
• Demonstrated track record of successful tech transfers to CDMOs with an eye towards late stage and commercial process development.
• Must have direct experience or exposure to transition of processes from early stage to late stages such as process characterization, FMEA and PPQ campaigns.
• In depth knowledge of cGMP, ICH, WHO and FDA/EMA guidelines and experience utilizing them in a phase appropriate manner.
• Direct experience in design-of-experiments (DoE) and robust data analysis via industry standard statistical tools.
• Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders.
• Must have a creative and strategic attitude with the ability to work in a fast-paced environment.

Benefits

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc.