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Associate Director, Clinical Quality Control

Moderna

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Norwood, MA
LOCATION

Job Description

As posted by the hiring company

Job Overview:

The Role:
Moderna is seeking an Associate Director for a position based at their Norwood, MA site. Reporting to the Sr. Director of Quality Control, this individual will be responsible for leading the Clinical QC laboratory Operations and stability teams. The individual will directly oversee laboratory function in support of QC, in-process, drug substance and finished drug product testing for mRNA products produced at Moderna’s manufacturing facilities. He/she will oversee the implementation of laboratory testing capabilities, related method transfers, investigations, and assay/instrument troubleshooting. Also, will be responsible for supporting execution, harmonization, and integration of stability-related activities at testing facilities in compliance with QC processes, internal policies, procedures, and regulatory requirements.

The individual will act as interdepartmental liaison to various groups including Manufacturing, Quality Assurance, Regulatory, Analytical Science & Technology and other Technical Development colleagues.

Here’s What You’ll Do:

  • Manages laboratory personnel and oversees their selection, performance management, mentoring, and career development.

  • Assists in development of appropriate Standard Operating Procedures and training of personnel to ensure compliance.

  • Act as single point of contact for site and manage all stability related topics with the expertise to address directly or through collaboration with appropriate experts within the company network.

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

  • Leads Troubleshooting of methods and equipment.

  • Oversees QC testing as required to meet timelines.

  • Reviews of executed assay packages, in both paper and electronic formats. Includes review of chromatography data and other analytical outputs including the investigations and resolutions of deviations, OOS and OOT observations.

  • Participates in cross functional planning to align QC resources and constraints with business objectives.

  • Manages Stability testing in partnership with QC Stability Team.

  • Manages focus on clinical development pipeline.

  • Embrace synergies across ATO, AS&T, and Clinical QC

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

  • Participates in continuous improvements of quality systems (procedures and systems) to improve

organization effectiveness, quality assurance compliance, and regulatory and other requirements

  • Establishes and maintains a safe laboratory working environment

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

  • BS/BA degree in chemistry, molecular biology or other related scientific discipline.

  • BS with 10-15 years, MS with 8-10 years in cGMP Quality Control environment with 3-5 years in a leadership role.

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

  • Experience and technical knowledge of analytical methodology with demonstrated proficiency with QC Pharmaceutical Chemistry and Bioassays.

  • Responsible for execution, harmonization, and integration of stability-related activities at testing facilities in compliance with QC processes, internal policies, procedures, and regulatory requirements.

  • 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 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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