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Supervisor, Chemistry

Employer
Moderna, Inc.
Location
Norwood, MA
Start date
Jan 19, 2023

View more

Discipline
Science/R&D, Chemistry
Required Education
Associate Degree
Position Type
Full time
Hotbed
Genetown, Best Places to Work

Job Details

The Role:
Reporting to the Senior Manager/Associate Director of Quality Control, this individual will be responsible for leading a Clinical QC Chemistry Operations team supporting Modernas Personalized Cancer Vaccine program. The individual will directly oversee the Chemistry function in support of QC raw material, drug substance and finished product testing for mRNA products produced at Modernas manufacturing facility. This individual will oversee the implementation of chemistry testing capabilities, related method transfers, investigations, and assay/instrument troubleshooting. The individual will act as interdepartmental liaison to various groups including Manufacturing, Quality Assurance, Regulatory and Development.This position will be 12-h Day Shift.

Heres What Youll Do:

  • Manage a team of specialists/associates in support of Clinical QC Testing for Stability, Release and In process samples.

  • Participate in employee hiring, performance management, mentoring, and career development

  • Coordinate training, professional development and growth of the QC Associate and Specialist teams.

  • Manage authoring of quality systems records such as deviations, change controls, CAPAs

  • Leads Troubleshooting of methods and equipment.

  • Execute test methods & assays as needed to support team throughput.

  • Review of Executed assay packages, in both paper and electronic formats. Includes review of chromatography data and other analytical outputs.

  • Participate in cross functional planning to align QC resources and constraints with business objectives. Prepare, provide and manage schedules for testing.

  • Coordinate and Manage Stability testing in partnership with QC Stability Team.

  • Develop and manage scheduling and status monitoring tools to measure testing capacity, turnaround time and to communicate progress to the larger organization.

  • Participate in and partner with the Digital team to expand and optimize the use of the LIMS (LabVantage) system.

  • Provide guidance and support to the QC-Chemistry team for compliance issues. Support preparation, management and response to compliance audits.

  • Establish and maintain a safe laboratory working environment

Heres What Youll Bring to the Table:

  • BS/BA and minimum 5-8 years in cGMP Quality Control environment. 1-3 years in a leadership role.

  • In-depth knowledge of relevant FDA, EU, ICH guidelines and regulations.

  • Experience and technical knowledge of analytical methodology. HPLC experience is a must have, additional experience with particle analysis and plate based assays is preferred.

  • Proficiency and experience with scheduling, planning or project management skills, including detailed instrument and analyst scheduling.

  • Strong knowledge of digital quality systems (LIMS, QMS, CDS) preferred.

  • Experience with statistical data analysis

  • Demonstrated proficiency with Quality System Records, Deviations, Change Controls and CAPAs

  • Excellent quality control judgment and ability to assess, communicate and resolve complex issues efficiently and effectively.

  • Outstanding communication skills (verbal and written).

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

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

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 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.

#LI-ES1

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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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