Specialist, Int Drug Substance

The Role:
Moderna is seeking a 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 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 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.

Here's What You'll Bring to the Table:

• Bachelor's Degree with 3-8 years of experience in biopharmaceutical operations or a master's degree with 2-4 years of industry experience; 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.
• Knowledge and understanding of cGMPs.
• 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.

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
• Generous paid time off, including:
  • Vacation, sick time and holidays
  • Volunteer time to participate within your community
  • Discretionary year-end shutdown
  • Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)