This role is considered On-Site.

Overview

The successful candidate will be a part of the Process and Analytical Sciences group. Responsibilities will include process development, in-house non-GMP manufacturing, process transfer to CMOs, GMP manufacturing support and stage 1 process validation for siRNA oligonucleotides.

This position is onsite and will be primarily located at our Kendall Square office.

Key Responsibilities

• Leading and managing process development, optimization and scale up activities
• Overseeing in-process analytical method development and optimization
• Managing manufacture of oligonucleotide APIs in non-GMP environment. Ensuring material quality and timely delivery
• Authoring process description, technical protocols and reports. Leading process transfer activities and providing timely technical support for GMP productions.
• Reviewing and revising SOPs and manufacturing documents according to regulatory and procedural guidelines. Supporting process characterization activities.
• Working closely with manufacturing, AD/QC, QA teams and CMO/CRO in GMP manufacture and other CMC activities
• Overseeing day-to-day lab operations and equipment maintenance
• Drafting quality sections of regulatory filings.

Qualifications

• Ph.D. with 8 years of industry experience, preferably in oligonucleotide chemistry or relevant area.
• Knowledge of drug development process is preferred.
• Strong verbal and written communication skills.
• Technical background knowledge in solid phase synthesis and related processes, relevant analytical, purification and downstream process techniques (oligonucleotides, and oligonucleotide-conjugates preferred).
• Thorough understanding of process development and ability to integrate scientific findings/results across multiple research areas or development projects.
• Experience in process optimization and scale-up; protocols and report creation and execution.
• Experience with independently leading projects and managing people.
• Travel domestic or International (10%) may be required.

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.