Manufacturing Technician

1 week ago

Cambridge, United States Alnylam Pharmaceuticals Full time
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This role is considered On-Site.

Overview

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

Key Responsibilities

  • 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 0-3 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 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.

About Alnylam:Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by ‘interfering‘ with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture:Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we‘ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine‘s Top Biopharma Employers, one of America‘s Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.

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