Associate Specialist, Manufacturing (Batch Specialist)
ModernaTX, Inc.

Job Info

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The Role:

The individual in this role will be part of a cohesive team responsible for producing messenger RNA for commercial production or for evaluation in human clinical trials. This position will specifically focus on batch readiness and batch close out activities. The Manufacturing Associate Specialist uses knowledge of manufacturing biopharmaceutical unit operations, quality systems and digital infrastructure to as act as a batch readiness and close out lead for the team. The Specialist will be a key team member maintaining the production schedule, managing batch record close out and Manufacturing owned actions supporting product disposition. They will leverage knowledge of cGMP regulations to support some investigations and improvement initiatives within manufacturing operations. Additional functions include acting as a responsible liaison between the Manufacturing group and other partner groups (Facilities, Supply Chain, QA, etc.) This role will also work cross-functionally to assist in planning manufacturing activities, maintenance and calibration of equipment and instruments and provide oversight of batch close out work such as batch record review and completion. The Specialist must be technically capable with a good theoretical comprehension of general biopharmaceutical manufacturing equipment, principles and processes. The successful candidate must have a good understanding of current GMP and safety standards and be able to apply this knowledge in a GMP environment.

Here's What You'll Do:

• Practices and promotes safe work habits and adheres to safety procedures and guidelines
  
• Manufacturing lead for batch close out and product disposition
  
• Perform work record review to close records, data mining, oversight for aging records, weekly-monthly report assessments
  
• Leads small cross functional teams to drive manufacturing operations changes or improvements
  
• Utilizes manufacturing process knowledge to drive continuous improvement in process operations
  
• Works cross-functionally to assist in planning manufacturing activities, maintenance and calibration of equipment and instruments and maintaining schedule adherence
  
• Conducts complex document revisions and/or document management including batch production records and manufacturing procedures
  
• Participates in 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
  
• Works independently with minimal supervision and direction
  
• Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion
  
• Works cross-functionally to assist in planning manufacturing activities, maintenance and calibration of equipment and instruments and maintaining schedule adherence
  

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

• Bachelor's Degree with 1-3 years of experience in biopharmaceutical operations. Degree in Engineering or Life Sciences is preferred
  

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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