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Sr. Specialist, Manufacturing

Employer
Moderna, Inc.
Location
Norwood, MA
Start date
Sep 22, 2023

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Job Details

The Role:

Moderna is seeking a cGMP Specialist, Manufacturing to help support clinical manufacturing operations. This position is located at our GMP Manufacturing site in Norwood, MA. The individual in this role will be part of a cohesive team responsible for the vial filling, visual inspection, labelling, packaging operations for evaluation in human clinical trials. The Specialist uses expert knowledge of 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.

Heres What Youll 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 tech transfers 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 / tools

  • Own 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

  • Work independently with minimal supervision and direction

  • Escalate issues and constraints that have the potential to impact business objectives

Heres What Youll Bring to the Table:

  • Requires BS in a relevant science or engineering discipline with 3-5 years of experience in biopharmaceutical operations; Degree in Engineering or Life Sciences is preferred.

  • Knowledge and understanding of cGMPs.

  • Experience working with electronic batch records and thorough understanding of 21 CFR part 11 requirements

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, theinfrastructure 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 peopleare 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. Were 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)

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Company

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”

Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.

 

Stock Symbol:

MRNA  

Stock Exchange:

USNASDAQ GS

 

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Company info
Website
Telephone
617-714-6500
Location
200 Technology Square
Cambridge, MA
United States

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