The AD/Director, MS&T Chemistry will be responsible for leading the Manufacturing Science and Technology team in the development, implementation, and support of manufacturing processes for custom lipid and nucleotide production. This role will involve collaborating with cross-functional stakeholders to ensure the successful execution of technical aspects related to the production of lipids and/or nucleotides. The AD/Director will provide leadership and guidance to a team of MS&T engineers and contribute to the growth and transformation of the MS&T Chemistry group.
Heres What Youll Do:
Lead and oversee the growth and transformation of the new MS&T Chemistry group, establishing it as a high-performing technical support team.
Develop and execute strategies for the internalization, scale-up, and tech transfer of chemical synthesis processes, specifically in the production of lipids and nucleotides.
Recruit and provide technical leadership, mentoring, and coaching to the MS&T Chemistry team, which includes process engineers with expertise in chemical synthesis techniques and cGMP manufacturing.
Facilitate tech transfer activities to ensure successful implementation of processes for right-first-time cGMP manufacturing, both internally and at external manufacturing partners.
Provide oversight and direction for technical support of cGMP manufacturing, including troubleshooting, deviation investigations, process improvements, and change controls.
Collaborate with cross-functional teams to align MS&T activities with overall product development strategy.
Foster strong relationships and collaboration with technology development, CMC portfolio office, supply chain, regulatory CMC, analytical development, process engineering, quality, and manufacturing.
Lead cross-functional project teams focused on process improvement or the development of new manufacturing capabilities.
Communicate with executive leadership to drive alignment on critical decisions, strategy, and risk mitigations.
Influence the development of regulatory and performance qualification strategies for chemical processes. Contribute to the authoring of regulatory filings and support the review of the CMC part of regulatory submissions and Health Authority requests.
Heres What Youll Bring to the Table:
Bachelor's, Master's, or Ph.D. degree in Chemistry, Chemical Engineering, or a relevant pharmaceutical/chemistry science field.
Over 10 years of experience in the pharmaceutical or other chemical synthesis industry.
Expertise in small-molecule manufacturing, with a focus on chemical synthesis techniques, preferably in the production of lipids and/or nucleotides.
Proven track record of tech transfer, scale-up and implementation of novel manufacturing processes.
Previous leadership experience managing MS&T, Process Development, or Technical Development groups or functions within the pharmaceutical or chemical synthesis industry.
Demonstrated ability to recruit, mentor, and develop a technical staff.
Knowledge of CMC strategy, ICH guidelines, and experience in regulatory support tasks (IND, BLA, RTQ, and PAI).
Extensive knowledge of quality systems, cGMP, and industry standards throughout drug development, including the application of such standards to starting materials and excipients.
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!
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 firstname.lastname@example.org. (EEO/AAP Employer)