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Apogee Therapeutics · 2 days ago

Director, Cell Culture Development

Boston, MA

Full-time

Onsite

Director/Executive

$215K/yr - $230K/yr

10+ years exp

Apogee Therapeutics is a biotechnology company focused on developing differentiated biologics for treating various inflammatory and immunology indications. The Director of Cell Culture Development will manage CDMO relationships and oversee the technical leadership in cell culture processes, supporting the advancement of clinical assets and ensuring robust production for biologics.

BiotechnologyLife ScienceMedicalTherapeutics

H1B Sponsor Likely

Responsibilities

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

Qualification

PhD in relevant disciplineBiologics development experienceCGMP experienceTech transfer to CDMOsRegulatory submissions experienceDrug product developmentMulti-tasking abilityCross-functional collaborationCommunication skillsGrowth mindset

Required

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

Preferred

Experience with drug product development is preferred

Benefits

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

Company

Apogee Therapeutics

Apogee Therapeutics is a biotechnology company that offers therapies for immunological and inflammatory disorders.

Founded in 2022

San Francisco, California, USA

201-500 employees

https://apogeetherapeutics.com/

H1B Sponsorship

Apogee Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (2)

2024 (3)