Specialist, Manufacturing
ModernaTX, Inc.

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.

Here's What You'll 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
  

Here's What You'll 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 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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