Lead Manufacturing Technician

Job description

Overview: Under minimal supervision and with limited guidance, this individual will manufacture GMP 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. This individual will be back-up to the shift supervisor. This is an onsite, second-shift position based in Norton, MA. The schedule is Wednesday through Saturday, from 2:00 p.m. to 12:00 a.m. Key Responsibilities: Execute cGMP manufacturing operations using approved SOPs and batch records, with timely, accurate documentation. Troubleshoot equipment and process issues, coordinate with support groups, and create work requests to minimize production impact. Maintain a safe, compliant work environment by promptly reporting incidents, identifying risks, and supporting safety investigations and CAPAs. Initiate and own deviations, CAPAs, and other eQMS records; complete investigations and required documentation revisions in partnership with QA and leadership. Maintain equipment and room logbooks, review executed batch records, and support right-first-time and cycle-time objectives. Serve as a qualified trainer and unit operation owner across multiple manufacturing areas, including complex operations such as chemical synthesis and HPLC; create or revise applicable Unicorn methods. Support continuous improvement, NPI and technology transfer activities, engineering test plans, validation protocols, and off-hours on-call needs as required. Qualifications: Bachelors of Science (BS) degree preferred with a minimum of 5 - 7 years’ experience in a regulated GMP facility. Minimum requirements may be substituted for the equivalent combination of education and experience in the industry. Must possess a mechanical and scientific aptitude and be able to clearly and thoroughly document all work on existing forms and records. Safety and Compliance: Demonstrated commitment to maintaining a safe, compliant work environment. Operational Excellence: Ability to support highly effective and efficient production operations, with strong attention to detail in both execution and documentation. Must be able to execute strenuous, sometimes repetitive physical work on manufacturing shift schedule in classified cleanroom environments. Ability to lift objects up to 50 lbs, and push/pull objects including bulk materials up to 250 lbs with assistance. Ability to wear half face and full-face respirators / PAPR as required for chemical processing. Strong organizational skills and ability to work independently as well as in a team setting. Ability to lead and mentor peers and interact with department management. Effective written and verbal English communication skills. Strong time management skills, attention to detail, and an ability to work in a team setting. Familiarity with Unicorn, MS Word and Excel software is a plus. Prior experience training peers preferred. Ability to support shift hours including days, nights, weekends, rotating shifts, on-call coverage, or extended hours About Alnylam We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another. At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicant