Director, Cell Culture Development

• 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

• 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
• 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

Experience with drug product development is preferred

• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
• Commitment to growing you professionally and providing access to resources to further your development
• Apogee offers regular all team, in-person meetings to build relationships and problem solve