Associate Director, Device Development

Summary

Join Apogee Therapeutics as an Associate Director, Device Development and provide technical leadership in developing biologic/device combination products. As a subject matter expert, you will lead cross-functional teams, manage the quality management system, and oversee development and manufacturing with external suppliers. Responsibilities include authoring design control documentation, overseeing testing, establishing human factors strategies, and working with CMOs and CROs. You will also review manufacturing documents, support manufacturing, conduct root cause analyses, and collaborate with cross-functional teams. The role requires significant experience in biologic/device combination product development, regulatory requirements, and working with external suppliers. Apogee offers a competitive compensation and benefits package, including a great culture, flexible PTO, and professional development opportunities.

Requirements

• 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

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.)

Benefits

• A great culture, grounded in our C.O.R.E. values: C aring, O riginal, R esilient and E goless
• 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