The Associate Director, MS&T will be part of Moderna's Manufacturing Science and Technology team responsible for tech transfer, process implementation and technical support for ensuring the robust production of mRNA therapeutic for the Personalized Cancer Therapy program. The individual will direct a team of MS&T engineers and 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:
- Lead a team of process engineers with expertise in bioprocessing unit operations and cGMP manufacturing. Provide technical leadership, mentoring and coaching of departmental staff.
- Plan resource needs, hire and manage employees to meet organizational needs for the present and future.
- Oversee tech transfer activities and implementation to ensure timely and successful tech transfer to enable right first time cGMP manufacturing.
- Provide oversight and direction for technical support of cGMP manufacturing including troubleshooting, process improvements and change controls.
- Act as a cross function matrix leader responsible for ensuring MS&T activities and deliverables are in sync with overall product development strategy.
- Align with cross function team on key strategy, communicate the strategy within MS&T, develop plans to implement and execute MS&T deliverables needed to enable the strategy.
- Build strong relationships and work closely with technology development, CMC portfolio office, supply chain, reg CMC, analytical development, process engineering, quality and manufacturing.
- Lead cross functional projects teams tasked with platform improvement or building new manufacturing capabilities.
- Communicate with executive leadership to drive alignment of critical decisions, strategy and risk mitigations.
- Author sections of regulatory filings and support the review of the CMC part of regulatory submissions and Health Authority requests.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Biochemical engineer, chemical engineer, or biological/chemistry science degree with > 12 years of experience in the pharmaceutical or biotechnology industry. Advanced degree preferred (MS, Ph.D.)
- Prior leadership experience managing MST, Process Development, or Technical Development groups or function for a pharmaceutical or biotechnology company. Demonstrated ability to mentor and develop a technical staff.
- Knowledge in CMC strategy, ICH guidelines, and regulatory support tasks (IND, BLA, RTQ, and PAI).
- Extensive knowledge of quality systems, cGMP, and industry standards at all phases of drug development.
- Experience in cell and gene therapy or personalized medicine is preferred.
- 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.