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Sr. Specialist, External QA, Person-in-Plant (Sun-Wed) - Bloomington, IN

Employer
Moderna, Inc.
Location
Bloomington, Indiana
Start date
Mar 31, 2023

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Discipline
Clinical, Clinical Medicine, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

Job Details

The Role:

Moderna is seeking a Sr. Specialist within the External Manufacturing Quality Assurance, Drug Product department. This role is co-located with our External Contract Manufacturing Operations (CMO) locations. The individual in this role will be responsible for providing on-site and on-the-floor GMP oversight of Moderna product including Drug Product manufacturing, testing, inspection and packaging activities. The individual will work directly with CMOs and internal functions to ensure robust processes and systems are implemented in support of right-the-first time manufacturing of Modernas products.

Here's What Youll Do:

  • Partners with a cross-functional matrixed Moderna team to provide direct oversight of end-to-end Drug Product unit operations from material receipt, compounding, fill/finish, QC testing, visual inspection, packaging, material management and shipment of material across our CMO network.

  • Establish collaborative working relationships with CMOs and confirm compliance to cGMP to ensure all products meet safety, identity, strength, purity and quality requirements,

  • Point of escalation for on-the-floor operational issues to ensure timely, consistent, and clear communication to the matrixed Moderna working team.

  • Participates in tiered governance across Moderna and CMO to proactively monitor performance and drive continuous improvements.

  • Provides written assessments and coordinates knowledge transfer (flow of information) of ongoing unit operations within the matrixed Moderna team.

  • Oversee timely reporting and closure of Quality events including change controls, deviations, OOS, complaints, and CAPAs.

  • Oversight of change management and implementation plans.

  • Ensure timeliness, adequacy and completeness of batch record documentation.

  • Review and input for generation of new or revised master batch records, SOPs and other controlled documentation.

  • Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met.

  • Support internal and regulatory agency inspections at CMOs. Responsible to work with CMO compliance team to ensure CMOs are inspection ready.

  • Support the collection of data/metrics for Management Review

Heres What Youll Bring to the Table:

  • 8- 10 years of experience in the pharmaceutical/biotech industry within Quality Assurance, Operations, or Manufacturing Sciences & Technology.

  • Experience with GMP inspections or audits, preferred

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

  • Working knowledge of relevant FDA, EU, ICH guidelines and regulations.

  • Experience working with CMOs and relationship management.

  • Experience working with biologics or vaccine manufacturing preferred.

  • Experience with sterile Drug Product manufacturing

  • Excellent judgment and ability to communicate complex issues in an understandable way.

  • Outstanding communication skills (verbal and written)

  • Ability to manage multiple projects in a fast-paced environment

Additional Requirements of the Role:

  • Role requires Person-in-Plant responsibilities full-time.

  • Position may require travel up to 20%.

  • Role will be on-shift (Wednesday-Saturday or Sunday-Wednesday)

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 persons 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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Company

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”

Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.

 

Stock Symbol:

MRNA  

Stock Exchange:

USNASDAQ GS

 

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Company info
Website
Phone
617-714-6500
Location
200 Technology Square
Cambridge, MA
United States

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