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Director, Cell Culture Development

DirectorDirectorOtherRemoteLeadTeam 51-200H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

160 days ago

Salary

$215K - $230K / year

Seniority

Lead

Postgraduate Degree10 yrs expEnglish

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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