Manager, Analytical Development at ModernaTX, Inc.

Posted in Other 16 days ago.

Location: Norwood, Massachusetts





Job Description:

The Role:



This position will be primarily responsible for managing analytical activities to support late-stage clinical and commercial mRNA vaccine programs in the Analytical Development department as a technical program manager. The role will work with key stakeholders to define CMC timelines, identify key analytical deliverables and work with a matrix team to ensure all deliverables are executed and meet all applicable timelines. A broad scope of analytical activities will be overseen including method development, characterization studies, stability studies, analytical comparability assessments, method bridging studies, analytical investigations, etc. The Sr. Supervisor/Manager will run regular analytical subteam meetings, and will also interact with key stakeholders within Process Development, Analytical Science & Technology, Analytical Technical Operations, Regulatory CMC, Manufacturing, and Quality. The Sr. Supervisor/Manager will also contribute to authoring and/or reviewing analytical sections of regulatory filings. This role will contribute to efforts to define and streamline operational workflows within Technical Development, and contribute to the overall analytical strategy for mRNA vaccine programs.



Here's What You'll Do:



  • Plan and manage deliverables within Analytical Development to enable CMC milestones for clinical and commercial mRNA vaccine programs


  • Work closely with a cross functional team within Analytical Development, Analytical Sciences & Technology, Manufacturing, Process Development, Analytical Technical Operations, and QC. Participate in regular cross-functional Technical Development Team meetings.


  • Drive alignment within analytical development across activities, including the running of regular analytical subteam meetings


  • Contribute to the development of digital tools for tracking analytical deliverables, and support efforts to streamline and platform operational workflows


  • Works collaboratively across the organization to enable method readiness, transfer, performance and troubleshooting to support clinical and commercial development


  • Support regulatory filings and support the planning and execution of work needed to meet regulatory commitments


  • Contribute to the overall analytical strategy for mRNA vaccine programs as a part of the Analytical Strategy Team





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



  • BA: 5-8 years, MS 2-5 years of relevant industry experience in analytical chemistry, biochemistry, or a closely related field


  • Demonstrated ability to work independently and manage projects in a timely manner


  • A strong fundamental understanding of various analytical methods used to enable control strategies, and experience in the implementation of methods to support early or late-stage programs


  • Good understanding of regulatory requirements: ICH, USP/EP/JP etc.


  • Experience in authoring regulatory submission documents in pharmaceutical or biotech industries


  • Ability to think critically and demonstrate troubleshooting and problem-solving skills.


  • Strong interpersonal skills with an eagerness to participate and provide support in cross-functional teams


  • (Preferred) Experience in nucleic acid drug development (DNA, RNA, oligonucleotides)


  • (Preferred) Experience in project management within the biotech/pharmaceutical industry


  • (Preferred) Experience working in matrix project teams with members from R&D, partners, CMOs and CROs





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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