Senior Director, Cell Culture Development

Job Title: Senior Director, Cell Culture Development

Job Number: 33749

Location: Remote, 

Job Description

We are seeking a Sr. Director, Cell Culture Development to join the TechOps team. In this newly created role, you will be responsible for managing 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 clinical assets through clinical development, including the development of second-generation processes, resupply, and late-phase development as appropriate.  

Responsibilities

• Lead 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 the resolution of deviations
• Review and approve master and executed batch records; assist with investigations
• 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 with Regulatory to author and support regulatory submissions (IND, IMPD, amendments, IB, BLA, etc.)
• Develop phase-appropriate product understanding and control strategies using the QbD framework
• Create a 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

Required Skills

• PhD in relevant discipline (e.g., biology, biochemistry, biochemical engineering or relevant field) or commensurate years of education and experience
• 15+ years biologics development and manufacturing experience (including Postdoc)
• Significant experience with cGMPs.
• Proven track record of advancing assets from pre-clinical through IND and into late phase development
• Experience with the commercialization of biologics is preferred
• Substantial experience leading tech transfer to CDMOs and supporting campaigns
• Expertise in 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
• Availability to participate in calls across multiple international time zones
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Ability and willingness to travel up to 25%