The Role

Moderna is seeking a manager to help support site start up activities for our Commercial Individualized Neoantigen Therapy (INT) Program. This role will be based in Marlborough, Ma but may require regular travel to the Norwood, Ma location. As a Manufacturing Manager, you will lead a cohesive team responsible for manufacturing cGMP mRNA medications and leading start up activities from project phase to commercial manufacturing. The individual in this role will be accountable for leading a team in support of an automated, fast paced and short turnaround operation to deliver a mRNA medicine to patients. 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. The individual will play a key role in the commercial production ramp up in the Marlborough, MA facility by supporting commissioning activities while leading manufacturing operations. They will hire and develop a high-performing, flexible manufacturing team capable of meeting a fast-manufacturing operation timeline. This position demands a blend of scientific knowledge, operational expertise, and digital proficiency. You'll be an integral part of site startup team responsible for operational readiness, execution of Engineering and PPQ runs during the project phase which will last through 2024. The role will then transition into manufacturing of patient batches for 2025.

Here’s What You’ll Do

• Safely oversee the manufacture of mRNA medicines while adhering to Moderna’s safety procedures and guidelines.

• Ensure plans and resources (people, facilities, supplies etc.) are efficiently utilized to manufacture mRNA medicines and deliver on time startup project objectives.

• Lead development of batch records, SOPs and training materials for startup of commercial manufacturing at the Marlborough Facility.

• Closely partner with QA peers for rapid disposition of Moderna medicines.

• Understanding of INT process or previous experience in a commercial environment for either upstream, downstream, DP or Buffer Prep

• Experience with equipment qualification (IQ/OQ/PQ), process validation, etc.

• Proven track record of independently prioritizing and resourcing large workloads in a dynamic project environment. 

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

• Ability to effectively collaborate in a dynamic, cross-functional matrix environment.

• Has led the implementation of CI initiatives which have improved metrics related to TAT, cost, Deviation Reduction and / or training. 

• Ability to recruit, build and lead a high performing start-up team - provide examples of developing talent within their current or previous organization.

• Strong analytical and problem-solving skills to navigate the complex challenges of site start-up. 

Here’s What You’ll Need (Basic Qualifications)

• A BS in engineering or sciences and 8 years of experience in cGMP manufacturing processes in a pharmaceutical or biotechnology environment; 6 years with a Masters.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Previous leadership role leading and developing teams.

• Project management experience.

• Strong communication skills, working across a dynamic and complex operation.

• Subject Matter Expert on root cause analysis, complex investigational tools, change management and continuous improvement execution.

• Technical writing skills and proficient in GMP manufacturing processes including but not limited to TFF Systems, Chromatography systems, single-use process materials/consumables use, fermentation and cell banking operations.

• This position is site-based, requiring you to be at Moderna’s 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 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.

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

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