Associate Director, MST Drug Product

The Role:
This is a new role supporting the technology transfer and enablement of Modernas commercial DP operations. In this role, the Engineer III/Sr. Eng. is a subject matter expert in aseptic/sterile drug product manufacturing. The individual will be responsible for GMP implementation of aseptic filling process, for optimization and troubleshooting of the process, for investigation and SME support, and participate in development of the next generation processes.

Heres What Youll Do:

• Collaborate cross functionally with members of Technical Development, Manufacturing Operations, and Quality to enable commercial DP process

• Oversee technology transfer and help to operationalize the GMP manufacturing process

• Support process training for manufacturing operations

• Lead troubleshooting and investigational activities to resolve deviations or to improve operations.

• Analyze process information for insights that improve the reliability and performance of manufacturing operations

• Assist in Change Control management and in Regulatory submissions

Heres What Youll Bring to the Table:

• Biochemical engineer, chemical engineer, or biological/chemistry science degree with > 8 years of experience in the pharmaceutical or biotechnology industry. Advanced degree preferred (MS, Ph.D.)

• Experience supporting aseptic manufacturing operations and tech transfers as a SME

• Be a subject matter expert in atl east 2 areas below: Automated Visual Inspection, Cryostorage, Particulate Matter, Frozen CCI, PFS, FMEA/risk assessments, Packaging, Filtration, process monitoring

• Extensive knowledge of quality systems, cGMP, and industry standards at all phases of drug development.

• Experience in managing tech transfers at CMOs is preferred.

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 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 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.

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