Scientist at Alnylam Pharmaceuticals in Cambridge, Massachusetts

Job Description:

Scientist, Product Development

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.

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 (2019-2021), a Boston Globe Top Places to Work seven years in a row (2015-2021), a Great Place to Work in Asia, Japan, Brazil, the U.K., Germany, Spain, Netherlands, Italy, France and Switzerland, Seramount's 100 Best Companies (formerly Working Mother 100 Best Companies) and Best Companies for Dads, Bloomberg's Gender Equality Index two years in a row (2021-2022), among others. At Alnylam, we are committed to fostering a diverse, equitable and inclusive work environment, culture, and workforce, and we support several Employee Resource Networks.

The successful candidate will be responsible for formulation process development, scale up, and process characterization of RNAi products. The candidate will work closely with cross-functional teams and contract manufacturing organizations on drug product development, process transfer and oversight of manufacturing processes.

Summary of Key Responsibilities

• Formulation and process development, characterization of drug product in vials and in prefilled syringes. Responsibilities include initiating projects, literature review, experimental design, execution, data analysis, and report writing in support of early and late stage manufacture and process characterization activities
• Process optimization, scale-up and scale-down of process unit operations, criticality assessment and process control strategy development, and process monitoring and trending.
• Provide technical support during tech of the manufacturing process
• In-house and external drug product production of non-clinical, developmental and clinical materials
• Technical support for optimization of contract manufacturing processes
• Design, manage and supervise in-house lab activities
• Participate in cross functional project meetings, provide scientific expertise, and oversee team deliverables
• Author and review of technical protocols and reports in support of manufacturing process characterization activities
• Author and review quality sections supporting drug product for regulatory filings
• Position requires 5% travel and 50% lab work

Qualifications

• Ph.D. degree or Master's degree in chemical engineering, biochemical engineering, or pharmaceutical sciences, with 1-3 years of hands-on experience in parenteral formulation process development and process characterization
• Hands-on experience in parenteral drug product formulation process development and aseptic operation
• Hands-on experience in analytical and characterization methods for drug products and processes UPLC/HPLC, UV/vis spectroscopy, viscosity, density, titration and compendia assays, particle analysis
• Demonstrated in-depth understanding of formulation and process of designing experiments and interpreting results
• Experience in technology transfer and managing contract manufacturing
• Working experience with cGMP manufacturing
• Excellent oral and written communication, and interpersonal skills.
• Proficient use of JMP, and MS office including word, visio, excel, presentation, one note
• Ability to Work Independently
• Demonstrated strong operational execution, organization, and problem-solving skills
• Desire to work in a fast-paced, deadline-driven, results oriented 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.