Supervisor, Manufacturing, Drug Substance Operations

2 months ago

Norwood, United States Moderna, Inc. Full time

The Role

In this role, you will lead a cohesive team responsible for manufacturing cGMP mRNA medications for evaluation in human clinical trials. This position is located at our GMP Clinical Manufacturing site in Norwood, MA. This position will be 1st shift from 6:00 am to 4:00 pm Wednesday through Saturday; please note, this role is 4x10 schedule with a weekend day requirement

The individual in this role will be hands-on front-line leader, accountable for leading a team in support of a manual, fast paced and short turnaround operation to deliver mRNA medicines to the clinic. He/she will apply existing and new knowledge of bioprocess unit operations and cGMPs to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. They will play a key role in the Clinical Manufacturing ramp up in the Norwood, MA facility by supporting commissioning activities while leading day to day manufacturing operations. They will assist in the hiring and development of a high-performing, flexible manufacturing team capable of meeting a fast-manufacturing operation timeline.

Heres What Youll Do

Safely produce mRNA medicines

Ensure plans and resources (people, facilities, supplies etc.) are efficiently utilized to manufacture mRNA medicines and deliver on time to the clinic

Oversee the hiring, training, development, retention and performance of staff for the leadership and execution of manufacturing operations.

Develop SOPs and training materials for ramp up for PCV production at the Norwood Facility

Closely partner with QA peers for rapid disposition of Moderna medicines

Develop comprehensive operating plans and monitors achievement of business and financial goals.

Development of effective working relationships with both internal and external partners.

Additional duties as may be assigned from time to time

Heres What Youll Need (Basic Qualifications)

A BS in the sciences typically with 5-8 years experience in all aspects of the manufacturing process in a pharmaceutical or biotechnology environment.

Thorough knowledge and understanding of cGMPs and FDA guidelines in Drug Substance and/or Drug Product is required.

Heres What Youll Bring to the Table (Preferred Qualifications)

Highly preferred to have a track record of success in leading and developing high performing teams and/or complex projects in a fast paced and changing pharmaceutical or biotechnology environment

Ambitious and self-starting attitude to take on responsibilities and own process improvements.

Experience in electronic batch records, Syncade, OSI PI, eDMS, and SAP preferred.

Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP.A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

This position is site-based, requiring you to be at Modernas site full-time. This position is not eligible for remote work.

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 optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous 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 thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-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.

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.

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 contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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