What are the responsibilities and job description for the Scientist, Process Sciences position at Alnylam Pharmaceuticals?
Overview:
The Scientist, Process Sciences will be a member of the Process Transfer team. Responsibilities will focus on drug substances, including process transfer to external and internal CMOs, process development, support of non-GMP manufacturing, and early stage GMP manufacturing of oligonucleotide-based APIs.
This position is onsite and will be located at our Kendall Square office in Cambridge, MA.
Key Responsibilities:
- Contribute to process development and optimization of Oligonucleotide manufacturing process and Technology Transfer Projects.
- Manage in-process analytical method development and utilization.
- Work closely with cross-functional teams (R&D, Quality, Analytical Development, Supply Chain) to ensure seamless coordination and successful execution of manufacturing projects.
- Provide technical support for GMP manufacturing, including process fit assessment, batch record review, and process excursions.
- Authoring and reviewing technical protocols and reports in support of manufacturing process development.
- Authoring, review, and approval of technical documentation, including process development reports, process flow descriptions, campaign summary reports, batch records, change controls, SOPs, and data verification, ensuring compliance with internal procedures.
- Communication of relevant information and results to CMC development team as well as other key stakeholders throughout the organization.
Qualifications:
- Ph.D. in Organic Chemistry or Chemical Engineering with minimum of 2 years of experience in industrial settings preferred.
- Expertise and experience in solid phase synthesis of oligonucleotides, oligonucleotide-conjugates or comparable biopolymers is a plus.
- Thorough understanding of the analytical and purification techniques for oligonucleotides, and oligonucleotide-conjugates (with lipids, peptides, and small molecules) used in characterization of oligonucleotides.
- Direct experience with using and troubleshooting DNA/RNA automated solid-phase synthesizers is preferred.
- Proficiency in authoring, reviewing and execution of manufacturing and process development documentation.
- Ability to integrate scientific principles/findings/results across multiple research areas.
- Experience with statistical design of experiments (DOE), good verbal and written communication.
About Alnylam:
We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.
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.
