Lead, Quality Control

This role is considered On-Site.

Overview

The Quality Control Lead is a key contributor in supporting the department's efforts to maintain the highest standards of quality and compliance from development through to commercialization. The Lead will primarily focus on establishment of evening and/or weekend operations, responsible for performing routine and non-routine testing while also contributing to laboratory operations, data review and trending, investigations, method transfers, and regulatory activities. With responsibilities extending from development through commercialization, the QC Lead ensures critical activities are executed with precision, enhancing the overall efficiency and effectiveness of QC functions.

This position is onsite at the Norton Manufacturing Facility in Norton, MA, with potential occasional responsibilities at other Alnylam locations. The role requires flexibility for evening and/or weekend coverage to support a continuous operational schedule.

Key Responsibilities (including but not limited to):

• Perform and may oversee routine and non-routine analytical assays to support raw materials, in-process samples, product release, and stability studies, following established SOPs.
• Contribute to the establishment of evening and/or weekend operations as part of the lab's flexible scheduling to maintain continuous quality control operations (Analytical, Microbiology, Raw Materials). This may include oversight of contractors, as applicable.
• Ensure timely and accurate data review, qualifying as a data reviewer to expedite the availability of results for critical decision-making.
• Maintain laboratory equipment and inventory, including the preparation of reagents and samples, to ensure smooth and uninterrupted operations.
• Support and participate in the execution of raw material processes, including SAP transactions, and ensure data integrity and efficiency in laboratory workflows.
• Drive the revision and optimization of controlled documents, including SOPs, work instructions, and test methods, to align with industry standards and regulatory requirements.
• Ensure adherence to internal policies, GxP standards, and regulatory guidelines to uphold compliance and inspection readiness.
• Identify and lead initiatives to enhance laboratory methods, processes, and overall operational efficiency while mitigating risks.
• Support metric and KPI reviews to identify trends and proactively address potential quality risks.
• Collaborate with QC and cross-functional teams, including CMC Development, Manufacturing, Manufacturing Technical Services, Materials Management, and Quality Assurance, to ensure alignment with organizational goals.
• Act as a key contributor during regulatory submissions, data verification processes, and inspection readiness activities.
• Provide mentorship and training to peers, fostering a culture of technical excellence and compliance.
• Participate in onsite audits and inspections, representing the QC function and ensuring preparedness.
• Proactively pursue professional development opportunities to remain at the forefront of QC analytical techniques and regulatory compliance.

Qualifications

• A degree in chemistry, biology, biochemistry, or a related scientific field is preferred, but a combination of education, training, and relevant experience will also be considered.
• At least 8 years of experience in a GMP Quality Control function within the pharmaceutical or biotech industry, or equivalent, with a demonstrated increase in responsibility.
• Significant experience in method transfer and/or analytical method implementation, with a strong understanding of method lifecycle management and phase-appropriate approaches.
• Proven technical writing skills, with a preference for experience in authoring investigations or similar documentation.
• Proficiency in data analysis and interpretation with excellent attention to detail to support informed decision-making.
• Strong problem-solving skills with experience in conducting investigations and developing/implementing CAPA.
• Exceptional organizational skills, with the ability to manage multiple tasks effectively and independently.
• Excellent communication and teamwork skills, fostering collaboration across diverse teams.
• Familiarity with LabWare LIMS, Excel, Word, and PowerPoint is preferred but not required; a willingness to learn and adapt to new systems is essential
• Proficiency in LIMS, Excel, Word, and PowerPoint preferred

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.