Associate Director, Device Development

Apogee Therapeutics Inc.

Remote, US
Base: $180,000 - $200,000; bonus/equity: performan...
Remote
10+ years industry experience
Biologic/device combination products
Prefilled syringe with needle safety device
The role provides technical leadership to develop first-class patient-centric biologic/device combination products for a fast-paced clinical-stage biotechnology company

Job Summary

  • The role provides technical leadership to develop first-class patient-centric biologic/device combination products for a fast-paced clinical-stage biotechnology company.
  • Candidates will act as a subject matter expert overseeing technology transfer, cGMP manufacturing, and regulatory submissions for prefilled syringes and autoinjectors.
  • The position offers competitive compensation including base salary, performance bonus, equity grants, and a comprehensive benefits package with three weeks PTO.

Matching Summary

The role provides technical leadership to develop first-class patient-centric biologic/device combination products for a fast-paced clinical-stage biotechnology company.

Salary

Base: $180,000 - $200,000; Bonus/Equity: Performance bonus and equity grant opportunities; Benefits: Health, welfare, retirement, 3 weeks PTO, paid sick leave

Skills & Requirements

Must-have

  • 10+ years industry experience
  • Biologic/device combination products
  • Prefilled syringe with needle safety device
  • Autoinjector or on-body injector
  • Design and Development Verification plans
  • Test Method Validation
  • ISO 14971 risk management

Nice-to-have

  • Advanced degree in engineering
  • Late phase clinical development experience
  • Commercialization of combination products
  • Root cause analysis expertise
  • Cross-functional collaboration skills
  • C.O.R.E. values alignment

Key Requirements

  • Minimum 10 years relevant industry experience
  • BS in mechanical, biomedical, or chemical engineering
  • Hands-on experience with prefilled syringes and autoinjectors
  • Understanding of 21 CFR Part 4 and ISO 13485
  • Experience with CMOs and cGMP manufacturing facilities
  • Ability to travel up to 25% domestically and internationally

Work Rights

Not specified

Tailored Resume

Cover Letter