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Associate Director, Manufacturing Science and Technology

3 weeks, 6 days 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 22

Description

  • Develop phase-appropriate product understanding and control strategies using a QbD framework and risk assessment.
  • Support clinical and commercial GMP drug substance manufacturing across the product lifecycle, including tech transfer, campaign analysis, and diagnostics.
  • Author and review technical reports, master batch records, executed batch records, procedures, and presentations.
  • Provide technical oversight to CDMO partners, including onsite Person in Plant support when needed.
  • Lead investigation support and resolution of deviations in collaboration with internal teams and external partners.
  • Analyze process and manufacturing data to understand and improve process performance.
  • Develop process characterization and PPQ strategies and associated documentation.
  • Support regulatory activities, including submission preparation and site inspections.
  • Coordinate with drug product, device development, analytical development, clinical supply chain, QA, RA, and other partners to ensure end-to-end product delivery.
  • Develop and maintain cost-of-goods models and sensitivity analyses to support process improvement decisions.

Requirements

  • PhD in biology, chemistry, biochemistry, bio/chemical engineering, or a related field, or equivalent education and experience.
  • 7+ years of biologics development and manufacturing experience.
  • Experience with late-stage development and commercialization of monoclonal antibodies.
  • Experience across relevant process areas such as upstream cell culture, downstream processing, solution preparation, cleaning, automation, and data systems.
  • Experience supporting tech transfer to CDMOs and scale-up/validation/PPQ activities, including Person in Plant and pre-approval inspection support.
  • Experience with process and economic modeling of drug substance manufacturing processes.
  • Demonstrated ability to collaborate with cross-functional partners across clinical development/operations, analytical development, QA, RA, and supply chain.
  • Excellent communication skills with the ability to tailor presentations for different stakeholders.
  • Ability to multitask in a fast-moving organization and work across multiple international time zones.
  • Ability and willingness to travel up to 25%, including domestic and international sites, and attend Apogee All Hands meetings twice per year.

Benefits

  • Anticipated salary range of $175,000 to $195,000.
  • Performance bonus and equity grant opportunities.
  • Health, welfare, and retirement benefits.
  • Three weeks of PTO, two one-week company-wide shutdowns per year, and dedicated paid sick leave.
  • Access to professional development resources and growth opportunities.
  • Regular all-team in-person meetings to build relationships and solve problems.
  • A fast-paced, highly dynamic work environment with opportunities to help shape the company culture.

Interested in this position?

Apply directly on the company website

Apply Now

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