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Director, Clinical Biomarker Lab QC

Employer
Moderna, Inc.
Location
Norwood, MA
Start date
Feb 22, 2024

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Job Details

The Role

We are seeking a highly motivated, collaborative, and innovative Director of GLP/GcLP Compliance within the Clinical Assay, Supplies and Logistics (CASL) team who will provide strategic direction and coordination of compliance assessment monitoring of Clinical Biomarker and Bioanalytical Molecular Assay (BMA) laboratories and clinical testing activities to ensure compliance with internal processes, applicable GLP/GcLP regulations, and regulatory requirements.

Position Overview

The Director will lead, direct, coach, and develop a team of QC Compliance Professionals within Modernas state-of-the-art biomarker laboratories. The incumbent will provide technical and managerial leadership by interfacing and collaborating with the bioanalytic team of Quality Control (QC) compliance professionals, and members of the laboratory functions performing PK, immunogenicity, and PD assays to ensure data integrity of the respective data workflows (e.g., data acquisition, bench analysis, data transfers, and final report writing) in a fast-paced, quick turnaround laboratory environment. The team of QC compliance professionals will perform and evaluate quality control assessments on bioanalytical assays (e.g., multiplexing ligand binding assays, cell-based assays, Immunoassays, PCR assays, LC-MS assays), and PK (pharmacokinetics, pharmacodynamics), immunogenicity assays on primary and secondary endpoints (e.g., LNP and/or mRNA derived proteins). In addition, compliance professionals will perform and evaluate quality control assessments on and neutralizing antibodies (e.g., Virus Neutralization assays, and Flow Cytometry assays etc.) within the respective laboratories.

The Director will provide compliance and quality support and guidance related to laboratory activities and will play an integral role in the identification and management of compliance and quality issues as well as to support deviation management, CAPA management and investigations performed by QA. The Director will be responsible for operational support and oversight of Good Document Management (GDP) practices, GLP/GcLP Compliance Training, and records management (including electronic and paper-based records) to ensure the laboratories are following applicable laboratory SOPs and protocols and current regulatory requirements. The Director will work within the Norwood or Cambridge, MA, laboratory facilities and report to the Senior Director, Risk Management & GxP Compliance.

Heres What Youll Do

  • Oversee hiring, development, and building a cohesive, high performing team with a strong sense of mission, providing training, mentoring, and performance management.

  • Build a team who can support QC review of data generated from bioanalytical, molecular and biomarker assays. Examples of assays are ligand binding assays, cell-based assays, LC-MS assays, molecular assays, virus neutralization assays, flow cytometry assays.

  • Support the development of this new function; organize, prioritize, and manage all aspects of workload to meet business needs.

  • Plan and oversee quality control checks, in addition to supporting compliance investigations for root cause analysis of critical and major deviations, compliance incidents, scientific fraud, and misconduct.

  • Coordinate with management and site operational leadership to ensure appropriate corrective and preventative actions are taken.

  • Work on complex problems where analysis of situations or data requires in-depth evaluation of various factors, strong judgment is required in resolving problems and making recommendations.

  • Identify innovative solutions to improve turn around QC time and to eliminate manual processes wherever feasible.

  • Collect and monitor quality and compliance metrics to provide regular status updates on quality and compliance and training metrics and highlight ongoing trends, signals, and actions taken.

  • Support the development of Inspection Readiness processes across the clinical assay laboratories.

  • Must be able to manage shifting parallel priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.

Heres What Youll Need (Minimum Qualifications)

  • Advanced degree required in relevant field (Pharmacy, Chemistry or Biology) with 7+ years of direct GLP/GcLP bioanalytical laboratory experience and compliance and/or quality assurance experience in the biopharma industry.

  • Working knowledge of ligand binding assays, LC MS assays, PCR assays, FLOW assays and cell-based virus neutralization assays

  • Working knowledge of quality systems and regulatory requirements for electronic record management (21 CRF Part 11/210/211) Knowledge of industry quality systems/standards and able to apply (applicable) regulations to monitor compliance, including, but not limited to EPA and FDA Good Laboratory Practice (GLP) Standards and Regulations, and GCLP guidance driven by implementation of published best practices to ensure quality of the data (e.g., Immunogenicity Testing of Therapeutic Protein Products - Developing and Validating Assays for Anti-Drug Antibody Detection, Bioanalytical Method Validation Guidance for Industry, Guidance for Industry Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications, and Committee for Medicinal Products for Human Use Guideline on bioanalytical method validation).

  • Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.

  • Ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.

  • Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels within the organization.

  • Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance.

Heres What Youll Bring to the Table (Preferred Qualifications)

  • You drive for results and set a high bar for yourself and others.

  • A natural ability to be organized in how you think, communicate, and conduct your work.

  • A digital first mindset

  • A curious mindset that allows you to constantly learn and challenge the status quo.

  • Great pride in your work - you recruit because you love it and enjoy having an impact on the growth of the Company.

  • Respect for others and a desire to work as a team. We win together.

  • Strong Excel skills and solid experience with PowerPoint and Word

  • A spirit of optimism, positivity and anything is possible mindset.

  • Sense of humor and ability to be flexible in a fast-paced environment

  • Preferred: Experience with Workday Recruiting

  • Preferred: Experience conducting behavioral based interviews and leading the process with clients

  • Preferred: Curiosity around technology and how to leverage to make better hiring decision

  • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

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!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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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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