Specialist, Manufacturing

The Role:

Moderna is seeking a Technical Specialist based at their Norwood, MA site. This individual will report to the Manager of DNA Manufacturing. The DNA operations will be transferring to Burlington, MA in the third quarter of 2022.

The individual in this role will be part of a cohesive team responsible for producing messenger DNA Plasmid as a raw material for clinical trials. The Technical Specialist uses expert knowledge of manufacturing biopharmaceutical unit operations, process engineering and digital infrastructure to both operate DNA processes as well as act as a technical leader for the team. The Technical Specialist will be a key technical trainer for the team and serve as a technical expert for Manufacturing for Tech Transfers and other key projects focusing on a lean, error-proofed and digital process. They will leverage knowledge of cGMP regulations to support some investigations and improvement initiatives within manufacturing operations. This role will consist of approximately 60% of their time operating and training and 40% executing projects.

Heres What Youll Do:

• Practices and promotes safe work habits and adheres to safety procedures and guidelines

• Utilizes manufacturing process knowledge to drive continuous improvement in process operations

• Manufacturing lead for tech transfers and other projects

• Facilitate cross functional teams to drive complex manufacturing operations changes or improvements

• Conducts complex document revisions and/or document management including batch production records and manufacturing procedures

• Performs training with staff on the floor

• Subject matter expert for a processing technology (chromatography, filtrations, digital systems, etc)

• Participates or leads cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology

• Strict adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.

• Monitor process operations to ensure compliance with specifications.

• Works independently with minimal supervision and direction

• Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion

• Creates and presents trending and metrics reports

• Participates in equipment start-up, commissioning, and validation activities

• Ensures equipment operational readiness

• Assists with troubleshooting in case of equipment failure, including impact assessment of out-of-tolerance records as needed

• Assists with deviation investigations as the pertain to processing technology expertise and related equipment or materials

• Participates in defining robust process parameters during routine manufacturing campaigns

• Works to optimize, trend, and report manufacturing process operational parameters during routine manufacturing campaigns

Heres What Youll Bring to the Table:

• Bachelor's Degree with 5+ years of experience in biopharmaceutical operations Degree in Engineering or Life Sciences is preferred.

• Knowledge in biologics drug substance purification operations (chromatography, TFF, aseptic technique) or a similar complex specialized environment

• Minimum of 1 years experience with deviation/investigation management systems or a similar technical writing system in a cGMP environment

• Excellent written and oral English language skills

• Demonstrated ability to lead cross functional teams and deliver results with minimal supervision

• Ability to manage multiple competing priorities in a fast-paced environment

• Background in lean manufacturing methodologies and operational excellence

• Project management experience

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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