Apogee Therapeutics is hiring a
Associate Director

Summary

Apogee Therapeutics is seeking an Associate Director, Device Development to lead the development of combination products within the Technical Operations team. The role requires 10 years of relevant industry experience, a BS degree in mechanical engineering, chemical engineering, biomedical engineering or a related field, and hands-on experience in developing biologic/device combination products.

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
• Hands-on experience in developing biologic/device combination products, specifically with prefilled syringe with needle safety device, autoinjector, and/or on-body injector

Responsibilities

• Technical lead on cross-functional teams responsible for development of combination products
• Work with Quality function to establish design controls procedures for combination product development
• 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
• 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.)

Preferred Qualifications

• Experience in late phase clinical development and commercialization of combination products
• Sound understanding of current regulatory requirements and industry standards for biologic/device combination products, including 21CFR820.30, ISO 13485

Benefits

• 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