Associate Director, Combination Products

Overview

Alnylam is the world’s leading RNA interference (RNAi) company.

Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality by harnessing the power of RNAi for human health as an innovative new class of medicines. We are a growing biopharmaceutical company with three approved medicines and a robust pipeline of investigational medicines focused in four strategic therapeutic areas: genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases, including several in late-stage development.

Headquartered in Cambridge, Mass., Alnylam employs over 1,500 people in 19 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe’s Top Places to Work six years in a row (2015-2020), a Great Place to Work in the U.K. and Switzerland two years in a row (2019-2020) and a Science Magazine’s Top Employer two years in a row (2019-2020). Please visit www.alnylam.com for more information.

The Combination Products Associate Director is part of the Combination Products Development team, which develops and maintains primary container systems, combination products, and packaging for all Alnylam combination products. The team supports the full product lifecycle from evaluation and selection through commercialization and product maintenance. This role will lead a team whose scope of work includes leading evaluation and selection of device components, maintaining the device platform, and leading development of packaging and labelling components. In addition, partnering with other teams to support regulatory filings and questions, managing changes initiated internally or by vendors, support complaint handling, and supporting implementation at CMOs.

This role collaborates extensively with cross-functional partners to meet design control timelines and mitigate risk.

Summary of Key Responsibilities

• Lead efforts to evaluate and select device components for CMC programs, including lifecycle management
• Lead and contribute to development of all DHF deliverables to support regulatory filings
• Oversee integration of risk management and Human Factors activities into development
• Plan test effort and support execution of testing, from early engineering tests through Design Verification
• Support planning and implementation of assembly, label, and pack operations at CMOs, including process control strategy
• Support evaluation and selection of primary container components
• Contribute as Subject Matter Expert in evaluation of product complaints and change notifications
• Continuously improve processes to support development activities performed both internally and through external vendors
• Ensure continuity and consistency of DHF documentation and methods across Alnylam’s product portfolio through templates and guidance documents
• Contribute as a Subject Matter Expert for Design Control and packaging development activities on Combination Product Programs
• Lead cross-functional reviews and updates to Alnylam’s Combination Product SOPs as well as synchronization with Alnylam’s overall QMS.
• Participate in development of clinical and commercial regulatory submissions.
• Drive timely decisions, and facilitate active communication and information flow between team members, Program Teams, and impacted sites/expertise areas
• Schedule and run cross-functional team meetings to manage execution of project plan
• Remain up to date with current regulations, industry guidance, and practices for consistent best practices across all Combination Product activities
• Resolve findings of internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues.

Qualifications

• Bachelor’s degree, preferably in engineering or life sciences.
• 10+ years related experience:
  • In assessment, development and/or manufacture of combination products
  • In development of medical device or pharmaceutical packaging
  • In design controls, documentation, specification development, testing, and risk management
  • Handling projects with external vendors and contract manufacturers
• Rigorous documentation and English written language skills
• Must have excellent interpersonal and customer-service skills
• Being fully vaccinated against COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) is required

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.