Specialist, Manufacturing PCV
ModernaTX, Inc.

The Role:

Reporting to the Senior Manager/Associate Director, Manufacturing Specialists, this individual will be part of a cohesive team responsible for producing high quality mRNA-based medicines for commercial production and evaluation in human clinical trials, specializing in personalized cancer vaccines. The Manufacturing Specialist uses expert knowledge of cGMP regulations and biopharmaceutical production processes to support day to day operational support through deviation and CAPA writing and projects with a focus on but not limited to DNA, mRNA or Fill Finish operations. These positions will be M-F, with occasional tasks outside working hours to support 24/7 operations.

Here's What You'll Do:

• Practice and promote safe work habits and adheres to safety procedures and guidelines
  
• Utilize manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues, deviations, non-conformances, and unexpected events
  
• Lead cross functional teams to drive complex investigation close outs, determine root causes and implement appropriate corrective and preventive actions (CAPA)
  
• Conduct document revisions and/or document management including batch production records and manufacturing procedures
  
• Participate in additional user forums for gathering ongoing requirements and prioritization and triage issues
  
• Follow-up on requests, issues, and projects and report statuses to manager/ working teams
  
• May perform metric trending
  
• May generate technical protocols and reports
  
• May support internal and external audits
  
• Work independently with minimal supervision and direction
  
• Perform work that consistently requires independent decision making and the exercise of independent judgment and discretion
  

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

• Bachelor's Degree with 5+ years of experience in biopharmaceutical operations or a Master's Degree with 2-5 years industry experience; Degree in Engineering or Life Sciences is preferred
  
• Subject matter expertise in biologics drug substance purification operations (liquid chromatography, TFF, aseptic technique) or a similar complex specialized environment, such as gene or cell therapy production
  
• A comprehensive understanding of investigational techniques such as Fishbone/Ishikawa analysis, 5-Why, Kepner Tregoe
  
• A comprehensive understanding of regulatory requirements and their applications in a cGMP environment
  
• Minimum of 2 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
  
• Experience working with electronic batch records and thorough understanding of 21 CFR part 11 requirements
  
• Background in lean manufacturing methodologies and operational excellence
  
• Experience interacting with representatives of regulatory agencies
  
• 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!

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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