Senior Scientist, Process Development

Job Title

The successful candidate will be responsible for process development, process characterization and scale-up of small molecules and oligonucleotide drug candidates.

• Process development, optimization, scale-up, and process and product characterization of small molecules and oligonucleotide APIs
• Development and characterization of biocatalytic processes for the manufacture of oligonucleotides
• Management and optimization of in-house and contract manufacturing
• Authoring, editing, and reviewing manufacturing documentation according to regulatory and procedural guidelines
• Authoring and reviewing technical protocols and reports in support of late phase manufacture and process characterization activities
• Working closely with analytical development, manufacturing, QA, QC and CMO/CRO on the process transfer and process optimization
• Providing technical input in the Quality section of regulatory filings
• Contributing to strategic technical discussions and presenting progress at internal and external scientific meetings

• Ph.D. in organic chemistry, chemical engineering, biochemical engineering, or molecular biology with 3 years of process research and development experience in biocatalysis
• Demonstrated proficiency in the design, development, and scale-up of biocatalytic processes for the manufacture of small molecules and oligonucleotides
• Demonstrated experience and in-depth understanding of process chemistry and analytical methods and techniques
• Hands-on experience in process development and analytical methods for process and product characterization
• Experience in process transfer and management of contract manufacturing
• Working experience with cGMP manufacturing
• Familiarity with cGMP, ICH and regulatory guidelines
• Excellent organizational and communication skills
• Demonstrated strong operational execution and problem-solving skills
• Desire to work in a fast-paced, deadline-driven environment

Alnylam Pharmaceuticals 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.