Supervisor, Manufacturing
ModernaTX, Inc.

Job Info

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The Role:

Moderna is seeking a cGMP Manufacturing Supervisor to lead a cohesive team responsible for manufacturing cGMP mRNA medications for evaluation in human clinical trials. This position will be 1st shift 7am-5pm Wednesday through Saturday; please note, this role is a 4x10 schedule with a weekend day requirement. The position is based out of our GMP Manufacturing facility in Norwood, MA.

The individual in this role will be hands-on front-line leader, accountable for leading a first shift team in support of a semi-automated, fast paced and short turnaround operation to deliver high quality mRNA medicines for evaluation in clinical trials. He/she will apply existing and new knowledge of bioprocess unit operations, such as chromatography and tangential flow filtration systems, and cGMPs to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will be able to document and communicate their technical and operational observations clearly and efficiently. He/she will be able to operate pilot-scale bioprocessing equipment and interact fluidly with peers/supervisors and cross-functionally with Quality Control, Quality Assurance, Logistical and Process Development Technology Transfer counterparts. They will hire and develop a high-performing, flexible manufacturing team capable of meeting a fast-manufacturing operation timeline.

Here's What You'll Do:

• Safely and compliantly 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. This requires clear communication to cross functional peers on a daily basis.
  
• Oversee the hiring, training, development, retention and performance of staff for the execution of clinical manufacturing operations.
  
• Develop batch records, SOPs and training materials as needed for various phases of clinical programs at the Norwood Facility
  
• Closely partner with QA peers for closure of documentation required for timely disposition of clinical batches.
  
• Develop comprehensive operating plans to ensure success of direct team and communication to other clinical platform teams. These plans will align with corporate goals and clinical trial demand.
  
• Effectively escalate information to Clinical Manufacturing management as required.
  

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

• Requires BS in a relevant science or engineering discipline plus 5 years' experience in a biotechnology manufacturing/quality/development environment; or an MS with 2-5 years' experience; or 10+ years professional experience with 5 years' being in a biotechnology manufacturing/quality/development environment.
  
• Previous management of people and projects is required, along with a proven track record of developing, leading and sustaining a high performing team
  
• Subject Matter Expert on the set up/use/process of TFF Systems, Chromatography systems, single use process materials/consumables is preferred.
  
• Thorough knowledge and understanding of cGMPs and FDA guidelines is required.
  

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 winter shut down
  • 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!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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