Sr. Scientist, Bioanalytical and Molecular Assay Team

Initial Therapeutics, Inc.; Norwood (MA); Hybrid; USD 80,000 - 140,000; Full time

Job summary

Join a pioneering company at the forefront of mRNA technology as a Sr. Scientist. This role offers the opportunity to lead bioanalytical and molecular assays, ensuring rigorous laboratory practices while supporting innovative clinical trials. Your expertise in biotransformation and analytical development will be crucial in advancing groundbreaking therapies. With a collaborative culture and a commitment to employee growth, this position not only promises professional fulfillment but also the chance to make a significant impact in the world of medicine. If you're ready to contribute to a mission-driven team, this is your opportunity to shine.

Benefits

Medical, dental, and vision coverage

Flexible Spending Accounts

Lifestyle Spending Account

Family care benefits

Free fitness and nutrition classes

Generous paid time off

401k match

Concierge service

Free parking or subsidized commuter passes

Location-specific perks

Qualifications

• 5+ years in biotech/pharmaceutical with strong biotransformation experience.
• Expertise in analytical method development across various platforms.

Responsibilities

• Support GLP/GCLP capabilities and method development for clinical trials.
• Design and execute analytical strategies for preclinical and clinical studies.

Skills

Biotransformation

LC-MS

Analytical Development

Protein Quantitation

Regulatory Compliance

Education

Ph.D. in Chemistry or related fields

B.S./M.S. with extensive bioanalytical experience

Tools

Thermo Watson

Lab Vantage

ELNs

Job description

The Role:

Moderna is seeking an experienced Sr. Scientist to join our Bioanalytical and Molecular Assays Team. This role involves supporting biotransformation and regulated non-clinical studies and clinical trials. A successful candidate will provide hands-on experiment, scientific and operational oversight of ADME, pharmacokinetic (PK), lipids, protein, and routine biomarker bioanalyses for Moderna's mRNA-based therapeutic pipeline.

Here’s What You’ll Do:

• Support establishing LC-MS GLP/GCLP regulated capability and facilitate method development, validation, and sample analysis to support clinical and preclinical programs. Responsible for in-house GLP/GCLP infrastructure, hands-on troubleshooting, systems and procedures to ensure adequate rigorous laboratory practices & regulatory requirements for bioanalytical activities assuring phase-appropriate approach.

• Perform biotransformation experiments which include but are not limited to metabolites ID, mass balance, protein binding, and ADME investigation for Moderna's mRNA-based therapeutic pipeline.

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

• 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).

• Assist in writing SOPs, regulatory submissions, and in responding to regulatory queries when needed. Hands-on experience in using various LIMS such as Thermo Watson, Lab Vantage, ELNs, etc. Knowledge of AI application in regulated bioanalysis is preferred.

• Deep knowledge of government guidelines and 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.

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

• Ph.D. in Chemistry, Biochemistry, Cell Biology, Immuno-oncology, Immunology, Cancer Biology, or related fields with a minimum of 5+ years of biotech/pharmaceutical industry experience. A B.S./M.S. with extensive bioanalytical experience will also be considered.

• Strong biotransformation experience. Familiar with HRMS and metabolite ID. Knowledge in ADME of therapeutic is a plus.

• 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 in clinical and preclinical toxicology studies.

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

• Experience managing third-party assay laboratories, collaborations, and relevant bioanalytical vendors preferred. Strong knowledge of regulatory guidance such as BMV, M10, and similar.

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

• This role is expected to be in office 70% of the time with flexibility to work from home up to 30%.

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, the infrastructure 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 people are 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.

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

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. We’re 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 contact the Accommodations team at [e-mail]. (EEO/AAP Employer)