Director, Cell Culture Development
Apogee Therapeutics
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $215,000 - $230,000 per year
Job Level
About the role
- 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
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
protein productionprocess developmentGMP manufactureprocess optimizationroot cause analysisprocess characterizationvalidation strategiesregulatory submissionsQbD frameworkdrug product development
Soft skills
collaborationcommunicationmulti-taskingleadershipgrowth mindsetpsychological safetystrategic visionproblem-solvingadaptabilitystakeholder engagement
Certifications
PhD in relevant discipline