Manufacturing Technician II (Norton, MA) - #390207

Alnylam


Date: 08/19/2021 19:00 PM

City: Cambridge, Massachusetts

Contract type: Full Time

Work schedule: Full Day

Manufacturing Technician II (Norton, MA)


(Job Number: 200170)



Overview


Alnylam is the world’s leading RNA interference (RNAi) company

Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality by harnessing the power of RNAi for human health as an innovative new class of medicines. We are a growing biopharmaceutical company with three approved medicines and a robust pipeline of investigational medicines focused in four strategic therapeutic areas: genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases, including several in late-stage development

Headquartered in Cambridge, Mass., Alnylam employs over 1,500 people in 19 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe’s Top Places to Work six years in a row (2015-2020), a Great Place to Work in the U.K. and Switzerland two years in a row (2019-2020) and a Science Magazine’s Top Employer two years in a row (2019-2020). Please visit www.alnylam.com for more information.


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. This individual will be responsible for coordinating either chemical synthesis or HPLC suite operations.


Key Responsibilities


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


  • Troubleshoot and resolve process and equipment 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 synthesis or HPLC operation areas. Provide technical training to junior employees; meet and maintain training material requirements
  • Be the SME for the synthesis or HPLC operation areas. This includes SOP, Unicorn methods, MBR, training material, and form ownership for the primary operation (synthesis or HPLC) and all supporting operations (buffer/column packing or solvent prep/column packing)
  • 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, 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 and review associated protocols.
  • On-call support during off hours may be required.

Qualifications


  • Bachelors of Science (BS) degree preferred and a minimum of 4-6 years’ experience in a regulated GMP facility.
  • Must possess a mechanical and scientific aptitude and be able to clearly and thoroughly document all work on existing forms and records.
  • Safety and the ability to maintain a compliant, highly effective and efficient product environment is critical. High level of attention to details in both operations and documentation is required. Familiarity with Unicorn software is a plus.
  • Strong organizational skills, attention to detail, and an ability to work in a team setting required
  • Excellent communication skills, adaptable, and flexibility with work schedules required.
  • Must be able to execute strenuous, sometimes repetitive physical work on manufacturing shift schedule in classified cleanroom environment
  • 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.
  • Minimum requirements may be substituted for the equivalent combination of education and experience in the industry.

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

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