Director, Cell Culture Development

We are seeking a Director, Cell Culture Development to join the TechOps team.  This role will be responsible for managing CDMO(s) to develop/implement processes that enable robust production of Drug Substance (DS) for protein-based biologics. This interdisciplinary position will provide technical leadership in cell culture 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 clinical assets through clinical development, including development of second-generation processes, resupply, and late phase development as appropriate.   The primary focus of this role will be to support late-phase tech transfer, manufacturing, and commercialization activities. 

Embedded in the Drug Substance Development and Manufacturing team, this position will be a member of an integrated Development, Manufacturing & Supply team, and will collaborate closely with team members involved in drug substance development, device development, analytical development, and supply chain.   

Key Responsibilities

• Guide process development of protein production from lab-scale to tech transfer and GMP manufacture at CDMOs (including onsite support when required, such as Person in Plant, inspection support, etc.)
• 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 and approve master and executed batch records; assist with investigations
• Author and review internal procedures, reports, and presentations
• Develop process characterization and validation strategies and documentation
• Support regulatory activities including submissions and site inspections from preparation through execution
• Liaise with DP, device development, and clinical supply chain as needed to ensure seamless end to end product delivery and robustness
• Collaborate cross-functionally with Regulatory to author and support regulatory submissions (IND, IMPD, amendments, IB, BLA, etc.)
• Develop phase-appropriate product understanding and control strategies using QbD framework
• Create late-phase development strategy to support potential commercialization.
• Collaborate closely with colleagues to ensure a seamless, highly integrated TechOps team
• Along with other TechOps team members, help shape goals and strategic vision for the TechOps organization 

Ideal Candidate

• PhD in relevant discipline (e.g., biology, chemistry, biochemistry, bio/chemical engineering, or relevant field) or commensurate years of education and experience
• 10+ years of biologics development and manufacturing experience 
• Significant experience with cGMPs.
• Proven track record of advancing assets from pre-clinical through IND and into late phase development
• Experience with commercialization of biologics, including regulatory expectations for marketing approval
• Substantial experience leading tech transfer to CDMOs and supporting campaigns
• Experience with drug product development is preferred
• Demonstrated aptitude in collaborating cross-functionally with analytical, formulation/DP, manufacturing, and/or supply chain is required
• Emerging leader 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
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Availability to participate in calls across multiple international time zones
• Ability and willingness to travel up to 25%, including domestic and international sites along with mandatory in-person attendance at All Hands meetings typically held twice per year

The anticipated salary range for candidates for this role will be $215,000-$230,000. 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.