Associate Director, Combination Products Development

This role is considered Hybrid.

Overview

The AD, Combination Products Development 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. 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.

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.
• 12+ years with Bachelor’s degree, 10+ years with Master’s degree, 8+ years with Doctorate degree 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
• Alignment with Alnylam’s core values: Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture, and Passion for Excellence

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.