Sr. Scientist, Cell Culture Development

We are seeking a Senior Scientist, Cell Culture Development to join the TechOps team. Reporting to the Cell Culture Director, this role will be responsible for working with CDMO(s) to develop processes that enable robust production of Drug Substance (DS) and Drug Product (DP) for protein-based biologics. This interdisciplinary position will provide stewardship of cell line development, cell culture and/or purification processes, including scale-up from lab to manufacturing scale. Support of manufacturing campaigns will be critical, including tech transfer, troubleshooting, deviation resolution, and campaign analysis activities. The role will be responsible for advancing drug candidates through clinical development, including development of second generation processes, resupply, and late phase development as appropriate. 

Key Responsibilities  

• Collaborate with CDMOs to guide process development of protein production from lab-scale to tech transfer and GMP manufacture  
• Analyze process and manufacturing data to understand and optimize process performance  
• Troubleshoot processes to identify root causes, propose corrective actions, and support resolution of deviations  
• Review GMP and non-GMP technical documentation (batch records, SOPs, guidance documents, and reports). 
• Author and review internal procedures, reports, and presentations  
• Interface with Research, Development, Quality, and Manufacturing colleagues to advance clinical programs from Discovery to FIH trials  
• Collaborate cross-functionally to support regulatory submissions (IND, IMPD, amendments, IB, BLA, etc.)  
• Assist in developing phase-appropriate product understanding and control strategies using QbD framework  
• Contribute to late-phase development strategy to support potential commercialization.  
• Collaborate closely with colleagues to ensure a seamless, highly integrated TechOps team  

Ideal Candidate  

• PhD in relevant discipline (e.g., biology, biochemistry, biochemical engineering or relevant field) or MS with commensurate years of education and experience  
• 4 years biologics upstream process development and manufacturing experience:
• CHO cell culture experience required
• In-depth knowledge of cell line development, cell culture development, media optimization, seed train development, bioreactor engineering, scale-up studies, scale-down models, process monitoring, unit operations, control strategies and technology transfer.
• Expertise in design of experiments, data analysis and data interpretation for process development studies.
• Experience working with late stage biologics programs, including process characterization studies, process validation, and risk management (e.g., FMEA)
• Experience with cGMPs 
• Experience in tech transfer to CDMOs and campaign support
• Demonstrated aptitude in cross-functional collaborations with analytical, formulation/DP, manufacturing, and/or supply chain is required
• Emerging team member with a growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment
• Excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
• Ability to multi-task and keep pace with a fast-moving organization
• Availability to participate in calls across multiple international time zones
• Ability and willingness to travel up to 25%

The anticipated salary range for candidates for this role will be $140,000 - $160,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.