Senior Combination Product Engineer

Senior Combination Product Engineer

Overview

Reporting to the Associate Director, Combination Product Development, the Senior Combination Product Engineer leads robust combination product technical development projects to ensure timely introduction of high-quality combination products into clinical trials and commercial markets.

Alnylam’s Combination Product Development (CPD) team supports the entire combination product lifecycle inclusive of selection and feasibility, clinical and commercial development, and post-market. CPD supports combination products for all appropriate phases of clinical development (early stage, late stage, and commercial).

This position is hybrid onsite and remote working and will be primarily located at Alnylam’s Cambridge, MA office and lab space.

Key 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 development 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

Qualifications

• 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.
• Must have experience in combination products / pharmaceutical industry
• Demonstrated leadership skills in a technical environment
• Must have 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 excellent interpersonal skills
• Ability to work in cross-functional teams
• Ability to work independently
• Ability to negotiate and influence partners towards an appropriate path forward

About Alnylam

We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.