Senior Combination Product Engineer

 This role is considered Hybrid.

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 appropropriate 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 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

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: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.