Manufacturing Engineer II

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 Manufacturing Engineer will be primarily responsible for technical, project, and GMP support across raw materials and drug substance manufacturing at Alnylam’s Norton, Massachusetts manufacturing site.

Key Responsibilities

• Work in a matrixed environment of engineering and scientific professionals to provide technical, project, and GMP support for raw material and oligonucleotide drug substance manufacturing.
• Perform “end user” Manufacturing review & approval of equipment life cycle documents (DQ, URS, FS, CS, etc. ) and validation protocols/reports.
• Perform Manufacturing impact assessment and change action creation for change controls (in consultation with Manufacturing team’s SMEs and SOP/MBR owners).
• Perform Manufacturing tasks / document reviews associated with onboarding of new raw materials and/or supplier change notifications (SCN) for Norton manufacturing operations.
• Support investigations, CAPA and implementation of process changes/technology transfer projects.
• Trend production data to analyze process performance and identify opportunities for improvements in robustness, compliance, yield, and cost of goods.

Qualifications

• Degree in chemical engineering or chemistry and 5-7 years’ experience (BS) or 3+ years’ experience (MS) in Drug Substance manufacturing in a pharmaceutical/chemical GMP controlled setting.
• Thorough knowledge of cGXP requirements for pharmaceutical manufacturing and commercial/clinical supply required.
• Must be able to work in cleanroom environment as needed.
• Potential to travel occasionally to participate in factory acceptance testing (FAT) for new equipment.
• Previous experience with small molecule/oligonucleotides is desired, but not required.
• Experience with GE/Cytiva Unicorn software is desired, but not required.
• 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.