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Associate Director, Manufacturing Science and Technology

1 hour, 29 minutes ago
United States
Full-time
Lead
Operations Manager
Operations
Apply Now
Apogee Therapeutics

Apogee Therapeutics

Apogee Therapeutics, Inc. is a biotechnology company dedicated to developing innovative biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immune diseases with high unmet needs. Their goa...

Biotechnology
1-10
Founded 2022
$169M raised
View All Jobs 13

Description

  • Develop phase-appropriate product understanding and control strategies using a QbD framework and risk assessment.
  • Support manufacture of clinical and commercial GMP drug substance across the product lifecycle, including tech transfer, campaign analysis, and diagnostics.
  • Author and review technical reports, master batch records, executed batch records, internal procedures, and presentations.
  • Provide technical oversight to CDMO partners, including onsite Person in Plant support when needed, and lead investigations and deviation resolution.
  • Analyze process and manufacturing data to understand and optimize process performance.
  • Develop process characterization and PPQ strategies and supporting documentation.
  • Support regulatory activities, including submissions and site inspections from preparation through execution.
  • Coordinate with drug product, device development, analytical development, and clinical supply chain teams to ensure end-to-end product delivery.
  • Develop and maintain cost-of-goods models and perform sensitivity analyses to support process improvements.
  • Collaborate across the integrated Development, Manufacturing & Supply organization to maintain a highly connected TechOps team.

Requirements

  • PhD in a relevant discipline such as biology, chemistry, biochemistry, bio/chemical engineering, or a related field, or equivalent education and experience.
  • 7+ years of biologics development and manufacturing experience.
  • Experience in late-stage development and commercialization of monoclonal antibodies.
  • Experience across relevant process areas such as upstream cell culture, downstream processing, solution prep, cleaning, automation, and data systems.
  • Experience with tech transfer to CDMOs and supporting scale-up, validation/PPQ, Person in Plant work, and pre-approval inspection support.
  • Experience with process and economic modeling of drug substance manufacturing processes.
  • Ability to collaborate effectively with cross-functional partners including clinical development/operations, analytical development, QA, RA, and supply chain.
  • Excellent communication skills with the ability to tailor messages for different stakeholders.
  • Ability to multitask in a fast-moving organization.
  • Availability to participate in calls across multiple international time zones.
  • Ability and willingness to travel up to 25%, including domestic and international travel, with attendance at Apogee All Hands meetings required.
  • Alignment with Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless.
  • Demonstrated growth mindset, willingness to learn from others, and commitment to a psychologically safe environment.

Benefits

  • Anticipated base salary range of $175,000 to $195,000.
  • Market-competitive compensation and benefits package.
  • Performance bonus eligibility.
  • Equity grant opportunities.
  • Health, welfare, and retirement benefits.
  • Three weeks of PTO.
  • Two one-week company-wide shutdowns each year and dedicated paid sick leave.
  • Access to resources that support professional development.

Interested in this position?

Apply directly on the company website

Apply Now

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