Moderna is seeking an AS&T (Analytical Science & Technology) Associate Director based at our Norwood, MA Moderna Technology Center. The individual in this role will focus on leading analytical activities for raw materials, critical reagents, and excipients, including but not limited to test method qualification, validation and method transfers. This person will manage method transfer and method qualification at manufacturing QC laboratories, globally, including a network of contract testing organizations (CTOs) and contract manufacturing organizations (CMOs), coordinating across teams 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 AS&T activities for raw materials test methods, support sites in regulatory and third-party inspections, author regulatory filing documents, and provide technical support for method development and troubleshooting.
Here’s What You’ll Do:
Drive and support the strategy and execution of method transfers and co-validations across Moderna QC testing sites and external CMOs and CTOs for Raw Materials and Excipients
Lead and/or support authoring of method acquisition, qualification, and validation protocols and reports; review and approve data packages.
Coordinate globally all relevant Change Controls regarding the introduction of new analytical methods.
Author sections for regulatory filing documents
Monitor and communicate method lifecycle (acquisition, qualification, implementation) timelines using project management tools.
Support laboratory out of trend (OOT) and out of specification (OOS) investigations.
Work closely with other AS&T and QC Labs, Digital/IT and Analytical Development to introduce novel approaches/technologies to improve overall method performance and throughput.
Support preparation, management and response to compliance audits (e.g. periodic cGMP inspections).
Surveille proactively regulatory requirements (international and domestic), industry guidance and emerging trends of regulators to ensure Moderna policies and standards remain current and are benchmarked against best practices.
Here’s What You’ll Bring to the Table:
Minimum education required: Bachelor’s degree in a relevant scientific discipline
Minimum experience required: BA: 10-15 years, MS 8-10 years, PhD 5 – 10 years in a GMP laboratory setting focused on analytical chemistry, or related discipline.
Minimum 8-10 years’ experience managing teams, including testing scheduling and lab project management.
Deep understanding and experience with EU and US regulations and ICH guidelines.
Deep knowledge and expertise in analytical method development, validation, and technology transfer as well as product characterization and analytical comparability.
Experience in data analysis and statistical evaluation and trending of data.
Experience in assessing, writing, and evaluating OOS’s and laboratory investigations.
Experience participating in inspections as a Laboratory/Method Subject Matter Expert (SME) and direct interactions with world-wide Health Authorities with diverse global authority (e.g. FDA, MHRA, EMA, PMDA)
Proven ability to lead and manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines.
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.
Ability to travel up to 15% of the time
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