The primary responsibilities of this role will be driving analytical control strategies and deliverables to support early and late phase program development within Modernas Technical Development Organization. More specific responsibilities include defining and implementing the overall analytical control strategy and deliverables to meet the needs of program development. The role will work with key stakeholders to define CMC timelines, identify 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, analytical comparability assessments, method bridging, analytical investigations, etc. This is a non-laboratory management-oriented scientific position in Analytical Development.
This role will be located at Moderna Technology Center in Norwood, MA. The individual will be a major contributor to mid and late phase mRNA-LNP drug development by leading, overseeing the full analytical scope and providing all necessary analytical support to the process development, manufacturing, quality, and regulatory teams.
Heres What Youll Do:
Represent analytical functions on Analytical and/or Technical Development Team(s)
Participate in establishment of analytical control strategies for the assigned programs.
Work with Technical Development Team Leads to create and update detailed program tracking system to ensure clarity of analytical deliverables and timelines and alignment with program development milestones and timelines
Facilitate and track analytical tasks and efforts associated with process development, analytical development, manufacturing, quality, and regulatory filing for assigned programs
Hold Analytical Subteam meetings with functional lines, drive discussions and define action items for follow-ups
Oversee method pre-qualification/pre-validation within Analytical Development, and support method qualification/validation at internal Analytical and Science Technology and QC groups as well as external CROs/CMOs as needed.
Oversee analytical testing at partner CMOs and CROs to ensure timely generation of high-quality data in collaboration with the GMP QC organization.
Support clinical phase method development, optimization and Investigations.
Provide analytical method development and optimization support for release and stability across analytical methods and platforms as appropriate.
Oversee implementation and alignment of analytical control strategy across development programs.
Serve as a subject matter expert in the formal GMP investigations of out of specification or out of trend analytical results in collaboration with the quality organization.
Generate high quality documentation to support regulatory filings and internal communications.
Review development stability and method development data, review analytical method performance on development materials in order to identify gaps and opportunities for improvement.
These efforts will be focused on mRNA-LNP process and product and will support mid and late phase development programs within Modernas Technical Development group. Analytical development in Technical Development is structured around a Centers of Emphasis model. Accordingly, the individual will liaise with the appropriate functional groups to drive and lead any method evaluation and optimization efforts and other analytical activities as appropriate for the programs that they are responsible for.
Heres What Youll Bring to the Table:
BS with 10+ years, MS with 8-10 years, or Ph.D. with 0-5 years of relevant industry experience.
BS/MS/Ph.D. in Analytical Chemistry, Biochemistry, Chemical Engineering, or closely related field.
Knowledge and extensive hands-on experience in analytical techniques including spectroscopy (UV, Fluorescence), separation techniques (UPLC, HPLC, CE), mass spectroscopy and physicochemical characterization (e.g. DLS, ITC, NTA, Particle counts, etc)
Experience in analytical and technology transfer to internal or external partners.
Experience in leading analytical control strategies to support biopharmaceutical development.
Experience in applications of regulatory guidelines to analytical method development and qualification and USP and Ph. Eur. methods.
Experience in authoring regulatory submission documents in pharmaceutical or biotech industries
Knowledge and hands-on experience of equipment platforms (e.g. Thermo, Waters, Agilent) and data processing software (e.g. Chromeleon, Empower and Openlab).
Familiarity with electronic notebooks, LES and LIMS
Knowledge of nucleic acid chemistry and biology and standard methods of analysis of these molecules
Basic understanding of pharmaceutical product development and analytical control strategy for therapeutics
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.
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 persons 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.