Senior Technician I (Norton, MA) (Sun-Wed 1st Shift)

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.

With limited supervision, this individual will manufacture clinical products in Train 1 at the Norton Manufacturing Facility ensuring safe, efficient and cGMP-compliant operations at all times. Responsibilities include but are not limited to operation of production equipment in the area of weigh/dispense, solution preparation, chemical synthesis, cleavage and deprotection, UF/DF, HPLC, annealing, concentration and lyophilization. Requires interaction with support groups (Facilities, Process Development, QC, QA and Validation etc.) to ensure accurate and well managed daily plant activities

Key Responsibilities

This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP) and Batch Records. Responsibilities include:

• Troubleshoot and resolve equipment and process related issues and interact with support groups to ensure production targets are met and product and process comply with cGMPs, EHS and corporate policies.
• Ensure all operations and documentation conform to cGMP standards and that all SOPs and batch records are maintained to reflect current manufacturing methods.
• Gain knowledge of and maintain status as a Qualified Trainer for specific equipment / unit operations. Provide technical training to junior employees; meet and maintain training material requirements
• Be the SME for a unit operation. This includes SOP, MBR, training materials, and forms ownership for at least one primary operation (UF, C&D, Concentration, Lyophilization, or Annealing).
• Use technical writing skills to initiate and provide subject matter expertise for deviations, CAPAs and change controls as required.
• Identify and support implementation of continuous improvement projects.
• Create work orders as needed, and coordinate activities to prevent maintenance and calibration events from impacting schedule.
• Perform Batch Record and Logbook requests and review manufacturing documentation to ensure compliance.
• Propose and review documentation revisions.
• Carry out work in a safe manner, notifying management of safety issues and risks.
• Support execution of equipment qualification protocols

Qualifications

• Must possess a mechanical and scientific aptitude and be able to clearly and thoroughly document all work on existing forms and records.
• Bachelors of Science (BS) degree preferred and a minimum of 3 - 5 years’ experience in a regulated GMP facility. Minimum requirements may be substituted for the equivalent combination of education and experience in the industry.
• Safety and the ability to maintain a compliant, highly effective and efficient product environment are critical. High level of attention to details in both operations and documentation is required.

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.