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 Product Realization documentation, including User Requirements Specifications, Design and Development Inputs, and Design and Development 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 for Design and Development Validation
• 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, BLA, etc.)

Ideal Candidate

• Minimum 10 years of relevant industry experience, BS in mechanical engineering, biomedical engineering, chemical 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 and Development Verification plans, protocols, and reports
  • Design and Development Validation and Design and Development 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 21 CFR Part 4, 21CFR820.10/ISO 13485
• Experience working with external device suppliers, 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% travel including mandatory in-person attendance at All Hands meetings typically held twice per year as well as domestically and internationally to vendor / CDMO sites
• 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 - $200,000. 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.