Alnylam is looking to solve the problem of introducing high-quality combination products into clinical trials and commercial markets in a timely manner.
Requirements
- Experience in combination products / pharmaceutical industry
- Experience with autoinjectors and prefilled syringes. Experience with other drug delivery devices will be considered.
- Rigorous documentation and English written language skills, e.g., test results, reports, requirements, and specifications
- Must have experience with design control and risk management deliverables
- Must have experience with product testing and reporting through lab activities
Responsibilities
- Lead the technical elements of combination product development projects in clinical and commercial phases
- Create technical development plans and strategies, including but not limited to design and developlement plans, selection/feasibility strategies, and design verification plans
- Contribute to product testing and reporting through lab activities. Actively contribute to design control and risk management deliverables
- Provide technical expertise to design transfer and control plans for final combination product assembly
- Represent CPD to internal stakeholders on cross-functional CMC teams and clinical and commercial supply chain teams
- Serve as Alnylam combination product technical SME to external partners
Other
- Bachelor’s degree, preferably in engineering (biomedical, mechanical, chemical, materials, etc.) or life sciences
- 7+ years of experience in combination product development or medical device development.
- Demonstrated leadership skills in a technical environment
- Excellent interpersonal skills
- Ability to work in cross-functional teams
