Director, Analytical Development

The Role:

This position will be primarily responsible for establishing and managing analytical strategies to support the development of mRNA lipid nanoparticles (LNP) as vaccines and therapeutics for clinical development program portfolio. The position will be responsible for strategic oversight and leadership focused on a full scope of analytical activities, including establishment of analytical control strategy, method development, qualifications and transfers, authoring and reviewing analytical sections for regulatory submissions, supporting CMOs/CROs and Moderna QC, and collaborating with Moderna Partner Analytical and Process Development teams, as well as Technical Development teams, Manufacturing and Quality. This position will be required to be a member of and work closely with Modernas Technical Development and CMC teams to ensure establishment and implementation of appropriate analytical approaches to support mRNA-LNP process and product development for clinical development programs. This position will lead a team of Scientists and Research Associates in a matrix environment. The position will report to the Strategy Lead, Analytical Development.

Here's What Youll Do:

• Defines analytical strategy that is scientifically sound, appropriate and incorporates industry best practices and health authority expectations to support the development of mRNA-LNP as vaccines and therapeutics.

• Work closely with the mRNA development team to identify CQAs, analytical methods and develop robust specifications.

• Defines qualification/validation strategy and writes/reviews associated documents to ensure global compliance for analytical methods including HPLC, LC-MS, Capillary Electrophoresis, ELISA, Bioassay, Spectrophotometric and compendial methods.

• Leads and oversees Research Associates and Scientists in a matrix environment, and works with QC and CROs to enable and execute analytical testing, method development, transfer and qualification.

• Conducts periodic review of method performance and work with team to design and execute remediation experiments and implement changes to existing methods as applicable.

• Works collaboratively across organization for method readiness, transfer, performance and troubleshooting to support preclinical and ealy clinical development.

• Champions high throughput analytical testing approaches via the use of automation and robotics.

• In collaboration with others works on establishing phase appropriate platform approaches and analytical control strategies for different mRNA-LNP modalities/therapeutic areas.

Heres What Youll Bring to the Table:

• PhD in biological sciences, chemistry or related scientific disciplines with a minimum 10-12 years of industry experience in small and/or large molecules drug development.

• Demonstrated experience with development, validation, transfer and lifecycle of analytical methods used in biologics process development and/or manufacturing environment.

• Experience in analytical techniques such as UV, Fluorescence, HPLC, LCMS, CE, GC, NMR, KF, IR, DSC.

• Prior management and mentorship experience and leading crossfunctional teams is a must.

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

• Ability to work independently and manage projects in a timely manner.

• Ability to effectively document and communicate results.

• Strong interpersonal skills with an eagerness to support colleagues in cross functional teams.

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

• (Preferred) Experience working with both early and late phase drug development programs.

(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 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

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 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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