Senior Engineer, Manufacturing Technical Services - Alnylam Pharmaceuticals, Inc

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 Technical Services group is searching for an exceptional candidate to join our team as a Senior Engineer.  The successful candidate will be responsible for technical and GMP support of internal manufacturing operations, especially for the supply of lipid nanoparticle (LNP) drug product.  This position is responsible for partnering with our internal manufacturing organization to establish a robust technical working relationship, implementation of process improvements, and ensuring process consistency for the LNP manufacturing process.  The candidate should have a strong background in biotechnology or chemical engineering and in using statistical tools to identify, analyze, and interpret patterns and trends in complex data sets for the diagnosis and prediction of process trends. 

The candidate will be responsible for fostering effective cross-functional working relationships with internal and external groups to support technology/process transfer, day-to-day manufacturing operations.  The candidate will utilize their technical process knowledge and relevant statistical tools to in resolving CAPA and deviation resolution, and change control scoping, as well as support regulatory submissions and risk assessments.

Key Responsibilities

• Work in a matrixed environment of engineering and scientific professionals to provide high level technical support for the lipid nanoparticle production process.
• Through application of scientific and engineering principles, become a technically competent process expert to support internal manufacturing with respect to decisions making to ensure continued supply and continuous improvement.
• Support deviation investigations and continued process improvement through statistical analysis of manufacturing data and thorough understanding of fundamental unit operation principles.
• Drive cGMP compliance in manufacturing, and identify process improvements opportunities
• Act as key technical contact including, but not limited to, providing PIP support, batch record review, technology transfer and validation support.
• Preparing reports for management stating trends, patterns, and predictions using relevant data
• Develop and foster a collaborative environment to ensure effective, constructive relationships between internal and external partners.
• Works with internal manufacturers to identify and implement cost savings and process improvements while working within the GMP framework.
• Previous experience with at least of the following is desired:
• LNP processing
• Parenteral/fill finish manufacturing operations
• Oligonucleotide, or small molecule production
• GMP manufacturing

Qualifications

• 6-9 years’ experience (BS) or 5+ years’ experience (MS) or 0 - 3 years’ experience (Ph.D.) in related science or engineering field
• Experience with lipid nanoparticle production, parenteral drug production chemical synthesis, solid phase synthesis, or small molecule manufacturing.
• Experience with statistical analysis tools such as JMP, Minitab, and SIMCA
• Proven ability to solve complex technical and equipment qualification challenges using a rational, scientific approach
• 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
• Knowledge of cGXP.
• 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.