Senior Scientist Process Development, Process Analytical Sciences
Overview
Alnylam (Nasdaq: ALNY) is delivering on a bold vision to turn scientific possibility into reality, with a robust RNA interference (RNAi) therapeutics platform. As the pioneer in RNAi and the leading RNAi therapeutics company, we have always been uncompromisingly dedicated to translating the breakthrough science into transformational medicines to help as many people as possible. Long focused on rare and genetic diseases, our scientific advances are now allowing us to bring the power of RNAi therapeutics to more prevalent diseases and as a result, we are beginning to recognize the full potential of this new class of medicines. You can learn more about our pipeline here .
Alnylam is committed to its journey to become a top 5 independent, global biopharma company. We are already admired and recognized for our dedication to patients, company culture that empowers people to do their best work, track record of scientific innovation, social responsibility, and commercial excellence.
Founded in 2002, and headquartered in Cambridge, Mass., Alnylam has over 1,650 employees at work across the globe. We are seeking smart, passionate, "change the world" kind of people who are ready to say, "challenge accepted" to our mission. Thanks to the commitment of every employee globally, Alnylam is proud to have been recognized as one of Fast Company's 2021 Best Workplaces for Innovators, a Science Magazine Top Employer three years in a row (2019-2020), a Boston Globe Top Places to Work six years in a row (2015-2021), a Great Place to Work in Asia, Brazil, the U.K., and Switzerland, Searmount's 100 Best Companies and Best Companies for Dads, Bloomberg's Gender Equality Index, among others.
Visit our careers website to learn more about our culture and opportunities at Alnylam.
The successful candidate will be responsible for process development, process characterization and scale-up of small molecules and oligonucleotide drug candidates. The candidate will work closely with cross-functional teams and contract manufacturing organizations on process development, process transfer and oversight of manufacturing processes.
Summary of Key Responsibilities
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
Qualifications
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
If employed in the U.S., being fully vaccinated against COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) is required
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.
