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Director, Bioanalytical Sciences

Employer
Moderna, Inc.
Location
Cambridge, MA
Start date
May 25, 2022

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Job Details

The Role:

Moderna is seeking an experienced Bioanalytical Sciences expert to join the Pre-Clinical and Clinical Bioanalytical team. A successful incumbent will provide Scientific and operational oversight of pharmacokinetic (PK), immunogenicity (ADA and Nab), and routine biomarker bioanalyses conducted at external contract research organizations (CROs) and internal assay laboratories for Moderna pipeline.

Here’s What You’ll Do:

  • Leads the Bioanalytical team for preclinical safety and defines science-driven, phase appropriate, and risk-based analytical development strategies to support the development candidate during advancing clinical development stages.

  • Responsible for the design and execution of phase-appropriate preclinical analytical strategies including immunoassay, quantitation of therapeutic proteins, lipid characterization, metabolite identification and PK/PD assay method development.

  • Establish LC-MS regulated capability and facilitate method development to support preclinical programs. Responsible for in-house infrastructure, systems and procedures to ensure adequate rigorous laboratory practices & regulatory requirements for analytical activities assuring phase appropriate approach. Responsibilities include analytical equipment procurement/qualifications, preparation and maintenance of SOP’s, determination, and control of critical reagents for example.

  • Evaluate and review raw data and study analytical reports and assay validation reports, as appropriate, to ensure laboratories are performing analysis in compliance with current regulatory, industry, and Moderna standards and that data are of the required quality (regulatory and scientific). 

  • Select, qualify, manage, and audit external CROs located globally.

  • Assist in writing regulatory submissions and in responding to regulatory queries when needed.

  • Stay abreast of literature, government guidelines, internal guidance on clinical trial conduct including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), internal SOPs and regulations and White Papers, as appropriate, for clinical bioanalysis to ensure practices are consistent with regulatory expectations.

  • Limited travel for vendor audits and training

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

  • Ph.D. in chemistry, biology, biochemistry or related field and 10+ years of experience

  • Experience with RNA, LNP and cell therapy preferred

  • Track record with analytical development with deep expertise with bioanalytical LC-MS platform to support PK/TK, efficacy and toxicology studies in preclinical models

  • Experience with analytical method development, across various platforms, (e.g., NGS, PCR, ELISA, MS, chromatography, etc.) including quantitation of therapeutic proteins in biological matrices, metabolite identification and impurity profiling.

  • Experience managing third party assay laboratories, collaborations, and relevant bioanalytical vendors preferred.

  • Demonstrated understanding of global regulatory requirements including GLP, GCP and the clinical trial process.

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.

#LI-AM1

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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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