Associate Specialist, Int Drug Substance

HERE’S WHAT YOU’LL BRING TO THE TABLE:

Minimum Qualifications
BS (Analytical Biochemistry, Chemistry, Organic Chemistry, Chemical Engineering, or a related field) with at least 2 years of experience in biopharmaceutical operations or a master’s degree.
Proficient in computer use for various business aspects, including executing electronic batch records, viewing procedures, and reviewing and approving documents.
Comprehensive knowledge and understanding of cGMPs and FDA guidelines are mandatory.
Embodies Moderna’s core values: Bold, Curious, Relentless, and Collaborative.
Preferred Qualifications
A degree in Engineering or Life Sciences is preferred.
Preferred to have a proven track record of success in leading or participating in complex projects within a dynamic pharmaceutical or biotechnology manufacturing environment.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage options
Flexible Spending Accounts for medical expenses and dependent care expenses
Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
Family care benefits, including subsidized back-up care options and on-demand tutoring
Free premium access to fitness, nutrition, and mindfulness classes
Exclusive preferred pricing on Peloton fitness equipment
Adoption and family-planning benefits
Dedicated care coordination support for our LGBTQ+ community

THE ROLE:

Moderna is seeking an Associate Specialist, Manufacturing to help support site start up activities for our Individualized Neoantigen Therapy (INT) Program. This position will be based at our state-of-the-art cGMP Manufacturing site located in Marlborough, MA. The individual in this role will be part of a cohesive team responsible for manufacturing top-quality mRNA-based medicines reporting to the Manufacturing Manager. The Associate Specialist uses expert knowledge of cGMP manufacturing practices, bioprocess unit operations, process engineering and digital systems to act as a technical leader for the manufacturing team. The Associate Specialist will be a key player in the development of operational procedures and training material, training manufacturing associates, supporting Tech Transfer activities, investigating issues that arise, and driving projects within the team focused on delivering Right First-Time results in an efficient manner. Standard working hours are from Monday to Friday during the day shift.

HERE’S WHAT YOU’LL DO:

Practices and promotes safe work habits and adheres to safety procedures and guidelines.
Provide on-the-floor coaching of the manufacturing team in execution of the process, troubleshooting, cGMPs, and safety practices.
Serve as the manufacturing lead for site start up activities and other projects.
Participate on and lead cross-functional teams to drive complex manufacturing operation changes, improvements, and issue investigations.
Work with process SMEs to develop batch records, SOPs, and training materials.
Closely partner with QA peers for rapid disposition of batches, including ensuring timely batch record, protocol, and log reviews, deviation investigation support, etc.
Support the investigation and own CAPA implementation for manufacturing deviations.
Own and manage change controls for projects within the team.
Own the purchasing and induction of simple equipment and tools.
Drive ops readiness for new product introductions, technology transfers, and major capital projects.
Participate in equipment start-up, commissioning, and validation activities.
Maintain a flexible schedule based on the demands of production and projects.
Perform tasks that consistently require independent decision-making and the exercise of independent judgment and discretion.
Escalate issues and constraints that have the potential to impact business objectives and/or project timelines.
Support regulatory audits as needed for manufacturing.