The Specialist, MS&T will be part of Moderna's Manufacturing Science and Technology team responsible for process implementation, technical support, and person-in-plant coverage to ensure the robust End-to-End production of our new mRNA Personalized Cancer Vaccine (PCV). The individual will work collaboratively with cross functional stakeholders such as Technical Development, Manufacturing, Regulatory, and Quality, to ensure all technical aspects of production are successfully executed.
Here's What You'll Do:
Here's What You'll Bring to the Table:
- Provide expertise in bioprocessing unit operations and cGMP manufacturing, responsible for technical support, change control, safety observations, manufacturing investigations, and person-in-plant coverage for the PCV process.
- Support process training for GMP operations and development of process understanding and expertise.
- Train and assist the manufacturing team in operational excellence projects driven by 5S, Lean Six Sigma, and similar programs.
- Lead/participate in cross functional technical process support and investigation teams.
- Partner with Technical Development, Manufacturing, and Quality to enable and sustain cGMP processes. Be the technical lead supporting cGMP manufacturing activities.
- Be the subject matter expert for plasmid, drug substance, and lipid nanoparticle processes for the PCV process. This includes troubleshooting process and equipment issues.
- Author deviation/investigation reports, technical reports, and manage technical CAPA/change controls.
- Establish and maintain process performance trending / metrics using digital information and statistical analysis tools.
- MS&T will be providing weekend coverage for Manufacturing and as part of the team you will need to be flexible to work a weekend day on a rotational basis
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Biochemical engineer, Chemical engineer, Biochemistry or Biology background. BS with 3 to 5 years of experience or MS with 1 to 3 years' experience in a pharmaceutical or biotechnology company.
- Demonstrated knowledge of cGMPs and experience providing technical support in a cGMP manufacturing environment.
- Demonstrated expertise bioprocessing including fermentation and purification of protein and/or nucleic acids. Expertise in at least one of the following areas: chromatography, membrane separations, fermentation, enzymatic reactions, and formulation.
- Technical agility. The capability to manage diverse technical areas.
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
- Preferred: Expertise in molecular biology
- Preferred: Experience in biologics process development and scale up / scale down.
- Preferred: Experience with single use bioprocessing technologies.
- Preferred: Proven track record leading and managing cross functional teams.
- Preferred: Knowledge of digital cGMP tools. For example: SAP, OSI PI(), MES (eBR), Unicorn, eQMS
- 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!
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.About Moderna
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.