Senior Manufacturing Associate

Overview

With limited Supervision this individual will perform routine and non-routine manufacturing operations at the Alewife Manufacturing Facility. Operations including but not limited to work functions in the area of weigh/dispense, solution preparation, formulation and UF/DF processing. Operates production equipment according to SOPs for the production of clinical and/or commercial products. Requires technical capabilities to interact with support groups (Facilities, Process Development, and Validation etc.) to ensure accurate and well managed transfer of process changes. Support floor operations to ensure safety, aseptic operations and compliance are maintained at all times.

Key Responsibilities

• Troubleshoot and resolve process related issues and interact with support groups to ensure production targets are met and product and process comply with cGMPs, product licenses 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.
• Use technical writing skills to own and complete deviations, CAPAs and change controls as required.
• Identify and implement continuous improvement projects utilizing independent project management skills.
• Create work orders as needed, and coordinate work 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 and process qualification and validation and review associated protocols
• Provide technical training to junior employees, meet and maintain training material requirements.

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 years’ experience in a regulated GMP facility, where 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.
• All activities in support of internal manufacturing at the Alewife manufacturing facility.

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 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 2022, one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2023 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. Alnylam is an E-Verify employer.