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Director, Cell Culture Development
Location
United States
Posted
160 days ago
Salary
$215K - $230K / year
Seniority
Lead
Job Description
Director, Cell Culture Development
Apogee Therapeutics
• 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
Job Requirements
- 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
Benefits
- A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
- Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
- We provide competitive time off, including 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
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