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Apogee Therapeutics · 1 day ago

Associate Director, Manufacturing Science and Technology

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

$175K/yr - $195K/yr

7+ years exp

Apogee Therapeutics, Inc. is a biotechnology company focused on developing differentiated biologics for treating various inflammatory and immunology conditions. The Associate Director of Manufacturing Science and Technology will lead late-stage development and commercialization activities, ensuring robust production processes for monoclonal antibodies while collaborating closely with cross-functional teams and CDMO partners.

BiotechnologyLife ScienceMedicalTherapeutics

H1B Sponsor Likely

Responsibilities

Develop and deliver phase-appropriate product understanding and control strategies using QbD framework and risk assessment

Support manufacture of clinical and commercial GMP DS throughout product lifecycle, including tech transfer, campaign analysis, and diagnostics

Author and review technical reports, master and executed batch records, working across internal team and with CDMO partners

Work closely with CDMO partners, providing technical oversight (including onsite Person in Plant support when required), and taking the lead in supporting investigations and resolving deviations

Analyze process and manufacturing data to understand and optimize process performance

Develop process characterization and PPQ 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

Develop and maintain cost of good models that describe process and enable sensitivity analyses for process improvements

Collaborate closely with colleagues to ensure a seamless, highly integrated TechOps team

Author and review internal procedures, reports, and presentations, as needed

Qualification

Biologics developmentMonoclonal antibodiesTech transferProcess characterizationRegulatory activitiesMulti-taskingCommunicationCollaborationGrowth mindset

Required

PhD in relevant discipline (e.g., biology, chemistry, biochemistry, bio/chemical engineering, or relevant field) or commensurate years of education and experience

7+ years of biologics development and manufacturing experience

Experience with late phase development and commercialization of monoclonal antibodies within relevant process areas (upstream cell culture, downstream processing, solution prep, cleaning, automation, data systems, etc.)

Experience with tech transfer to CDMOs and supporting DS campaigns through scale up and validation/PPQ, including person in plant and pre-approval inspection support

Experience with process and economic modeling of DS manufacturing processes

Demonstrated aptitude in collaborating with cross-functional partners, including clinical development/operations, analytical development, QA, RA, and supply chain

Excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly

Demonstrated growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment

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, attendance at Apogee All Hands meetings is required, typically held twice per year

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)