Moderna is seeking an Associate Director, Analytical Program Lead, based at our Norwood, MA Moderna Technology Center. The individual in this role will focus on leading analytical control strategy and activities for raw materials, critical reagents, and excipients, including but not limited to overseeing and developing analytical strategy for lipids, small molecules and raw materials, work with technical and operation teams across different functions in support of lipid excipients, small molecules, and raw materials. This person will support early to late phase development programs, support and oversee data mining/trending and statistical analysis generated with analytical methods for lipid raw materials, as well as mRNA - lipid nanoparticle drug products. This person will lead and provide technical and strategic management including a network of contract testing organizations (CTOs) and contract manufacturing organizations (CMOs), coordinating across teams internally and externally to meet business objectives.
This person is expected to work in a highly collaborative, cross functional team environment, and provide expert knowledge to the development, implementation, and maintenance of analytical activities in collaboration with Analytical Development, Process Development, Production, Clinical Ops., Reg. Affairs and Quality, author regulatory filing documents, and provide technical support for method development and troubleshooting, as well as creation of specifications and analytical controls.
Here’s What You’ll Do:
Drive and support the strategy, technical management and execution of analytical methods and activities for raw materials, small molecules, and lipids across Moderna sites and external CMOs and CTOs.
Develop and propose specifications for critical raw materials and lipid excipients
Lead and/or support creating, tracking, and managing technical deliverables and activities for project milestones; review and approve data packages.
Provide technical evaluation of projects, lead and contribute to strategy, review and management of development, qualification/validation protocols and reports utilizing ICH/Regulatory guidance.
Author sections for regulatory filing documents.
Monitor and communicate method lifecycle (acquisition, qualification, implementation) timelines using project management tools.
Work closely with Analytical Science and Technology, QC, Digital/IT and Analytical Development to introduce novel approaches/technologies to improve overall method performance and characterization of raw materials and excipients.
Follow proactively regulatory requirements (international and domestic), industry guidance and emerging trends and regulations to ensure Moderna policies and standards remain current and are benchmarked against best practices.
Provide subject matter expertise and utilize strong knowledge of synthetic chemistry for small molecules to support lipid and lipid nanoparticle related projects.
Oversee creation of and provide summary presentations and detailed reports to internal and external stake holders.
Lead a team of scientists/managers and collaborate cross functionally.
Here’s What You’ll Bring to the Table:
Minimum experience required: BA: 13-15 years, MS 8-10 years, PhD 6-8 years of relevant industry experience in analytical chemistry, biochemistry, chemical engineering, or closely related field.
Minimum 8-10 years’ experience leading teams, including lab project management.
Deep understanding and experience with US and EU regulations and ICH guidelines.
Deep knowledge and expertise in analytical method development, analytical control strategy as well as product characterization and analytical comparability, preferably for small molecules and lipids.
Experience in data analysis and statistical evaluation and trending of data.
Experience in assessing and contributing to technical investigations.
Proven ability to lead and manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines.
Experience in authoring regulatory submission documents in pharmaceutical or biotech industries
Ability to think critically and demonstrate troubleshooting and problem-solving skills.
Ability to interact effectively with all levels of personnel within the organization and externally with CTOs, CMOs, and third parties.
Ability to navigate through ambiguity and rapid growth and adapt to change.
Previous hands-on industry experience with analytical development for small molecules, lipids, nanoparticles, RNA and DNA therapeutics, and knowledge of synthetic chemistry is a plus and preferred
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
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 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.#LI-KP1