Original listing text, shown exactly as published by the company.
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.
