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Associate Director, Device Development

Remote

 

About Apogee Therapeutics
Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.
Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”
We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless. 
If this sounds like you, keep reading!

 

Role Summary

Apogee Therapeutics is seeking an Associate Director, Device Development to join the Technical Operations team to provide technical leadership in developing first class patient-centric biologic/device combination products for Apogee’s programs. Products include prefilled syringes with needle safety device and autoinjectors.

As a technical leader in an emerging company relying on a fully outsourced supply chain, the Associate Director, Device Development will act as a subject matter expert (SME) in biologic/device combination product design and development, technology transfer, and cGMP manufacturing oversight. This position will work closely with external suppliers, manufacturers and with other functional areas in Technical Operations and Quality to ensure development and manufacture of high-quality combination products to support clinical supply, commercial manufacturing and regulatory submissions.

 Key Responsibilities 

  • Technical lead on cross-functional teams responsible for development of combination products
  • Work with Quality function to develop and refine the combination product quality management system
  • Author product-specific design control documentation, including User Requirements Specifications, Design Input Requirements, and Design Verification plans, protocols, and reports
  • Oversee test method development, test method validation and design verification at external labs
  • Establish human factors strategies and work with human factors service vendors to execute formative and summative HF studies.
  • Work with contract manufacturing organizations (CMOs) and contract research organizations (CROs) to meet development, manufacturing, and supply goals
  • Review and approve manufacturing protocols, master and executed batch records, validation plans and reports, and other cGMP documents
  • Support person-in-plant during manufacturing at CMOs, as needed
  • Serve as technical SME in root cause analysis and deviation investigations
  • Author, review, and approve development studies and technical reports
  • Collaborate effectively with cross-functional teams, including analytical development, supply chain, quality assurance, and regulatory affairs
  • Serve as technical SME on due diligence and business development opportunities
  • Communicate findings and progress through presentations and reports
  • Author and support regulatory submissions (IND, IMPD, amendments, IB, BLA, etc.)

Ideal Candidate 

  • Minimum 10 years of relevant industry experience, BS in mechanical engineering, chemical engineering, biomedical engineering, or a related field required, advanced degree a plus
  • Must have hands-on experience in developing biologic/device combination products, specifically with prefilled syringe with needle safety device, autoinjector, and/or on-body injector. Experience should include:
    • Development of User Requirements and Design Input Requirements
    • Establishing statistical acceptance criteria based on reliability and confidence intervals
    • Statistical analysis of test data
    • Test Method Validation
    • Design Verification plans, protocols, and reports
    • Design Validation and Design Transfer
    • Process Validation
  • Experience in late phase clinical development and commercialization of combination products
  • Must have sound understanding of current regulatory requirements and industry standards for biologic/device combination products, including 21CFR820.30, ISO 13485
  • Experience working with external device suppliers and CMOs and cGMP manufacturing facilities
  • Experience performing risk management per ISO 14971
  • Experience with execution of root cause analysis and investigations
  • Strong communication and presentation skills
  • Availability to participate in calls across multiple international time zones
  • Ability to travel up to 25% domestically and internationally to vendor / CMO sites and company meetings
  • Ability to work independently and multi-task in a fast-moving organization
  • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless

The anticipated salary range for candidates for this role will be $180,000-$205,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. 

 

What We Offer
  • A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
  • Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
  • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
  • Flexible PTO
  • Two, one-week company-wide shutdowns each year
  • 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
 
E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.
 
Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
 
To review our privacy policy, click here

 

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