Moderna is seeking a Sr. Manager, Commercial Programs, based at their Norwood, MA site.
The successful candidate must have an extensive and broad analytical sciences background (chemistry, bioassay, raw materials, including compendial methods), a GMP background, demonstrated experience with method validations, reference material program management, regulatory submissions, and global change management for analytical methods.
This role will work with key stakeholders and within a matrixed team to execute on CMC deliverables pertaining to commercial analytical methods. This role entails a broad scope of analytical activities, including method validations and transfers, reference material program management, driving global change management projects for analytical methods, authoring regulatory submissions, leading trending programs, method bridging studies, analytical investigations, etc. This is a non-laboratory management-oriented scientific position in AS&T with direct reports.
Heres What Youll Do:
Direct management of team members focused on commercial analytical method-related programs.
Provide cross-network management, and oversight for analytical methods.
Manage method lifecycle projects and method performance trending globally across sites (Moderna, contract testing organizations and contract manufacturing organizations)
Lead analytical method validation, transfer, optimization, and remediation projects.
Lead the reference material program, including creation, qualification, requalification, and trending projects.
Provide expert knowledge for GMP investigations relating to commercial Analytical Chemistry, Raw Materials, and Bioassay methods.
Author regulatory submissions and support regulatory inspections.
Participate in cross-functional, multi-site, global meetings / projects and provide commercial method lifecycle monitoring and maintenance oversight.
Surveille 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.
Other responsibilities as needed.
Heres What Youll Bring to the Table:
Minimum education required: Bachelors degree in a relevant scientific discipline
Minimum experience required: BS: 14+ years, MS 10+ years in a GMP laboratory setting focused on analytical chemistry, bioassay, raw materials, etc.
Ability to navigate through ambiguity and rapid growth and adapt to change.
Management of direct reports.
Deep understanding and experience ICH, USP, Ph. Eur., FDA, guidelines.
Deep knowledge and expertise in analytical method validations and method transfers.
Experience in data analysis and statistical evaluation and trending of data.
Experience in assessing, writing, and evaluating laboratory investigations pertaining to analytical methods.
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, ANVISA)
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.
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.