Director, Device Platform

Cambridge, MA, United States

Work_Category - hybrid Description Overview

The Director, Device Platform Management manages a team of Scientists/Engineers to develop and execute implementation strategy for primary containers, devices, and combination products at Alnylam. Scope of work includes establishing and driving the implementation of device, primary container, and combination product technology platforms to meet pipeline needs. In addition, support existing commercial products and processes at internal and external manufacturing sites. They will work within cross-functional teams (with Quality, Supply Chain, Process Development, MTS, Regulatory, Clinical, and Commercial) to establish and manage project plans for clinical and commercial use. His/her team members will serve as representatives to support development activities on assigned CMC project team(s). Program activities will include evaluation of stakeholder needs, patient needs, evaluation and selection of vendors and manufactures, and evaluation and management of costs.

Key Responsibilities

Lead the establishment, development, and lifecycle management of primary container (syringe), device, and combination product programs to support Alnylam's portfolio of products

Interacts with clinical development partners (Clinical Ops, Regulatory, and Commercial) to provide expert development advice to assist the product teams

Collaborate with expertise areas (Quality, Supply Chain, Process Development, MTS, Regulatory, Clinical, and Commercial) to establish project plans and timelines for clinical and commercial activities including resource loading and risk mitigations

Review regulatory submissions for primary container, device, and combination product related scientific accuracy

Contribute as a subject matter expert in the areas of Design Controls, Human Factors, and Risk Management

Design, testing, selection, qualification, and production scale-up of primary packaging, devices, and combination product systems focused on meeting/exceeding patient needs

Technical representative for primary container, device, and combination product selection and evaluation of vendors, manufacturing and supply agreements, and qualification of vendors for supply and manufacture of components and finished products

Create and maintain documentation packages for platforms throughout their lifecycle, e.g., Design History Files

Facilitate the process for evaluation of alternative actions to operationally deliver plan. Influence and drive development of solutions, criteria, and implications

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 plans

Prepare and present project status reports and metrics to Program Teams and Management

Remain up to date with current regulations, industry guidelines, and practices to enable best practices across all activities

Exceptional planning and organizing skills to plan and manage resources against timelines and commitments; must excel in a dynamic environment

Alignment with Alnylam's core values: Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture, and Passion for Excellence

Qualifications

Bachelor's degree, preferably in engineering or life sciences. Advanced degree preferred but not required

Experience in the assessment, development and/or manufacture of drug products, primary containers, and devices required

Experience in design controls and testing, human factors studies and/or risk management required

Experience managing external vendors and contract manufacturers required

Experience managing cross functional teams required

Must have excellent interpersonal and customer service skills

Experience in building and leading a team

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 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 2022, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2023 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. Alnylam is an E-Verify employer.

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