Sr. Engineer I, MST Clinical Drug Product

The Role:
This position is part of Modernas Drug Product (DP) Manufacturing Science and Technology (MS&T) team. The main responsibility for this role is to perform technology transfer in support of Clinical Drug Product manufacturing at our Norwood site. Technology transfer includes working with Technical Development to define and lock the process, and to collaborate with stakeholders to define material, control, and equipment requirements for clinical batches. The incumbent is also expected to investigate deviations, manage change controls, and support Regulatory filings for Moderna products.

Heres What Youll Do:

• Support technology transfer projects including coordination of process information exchange, documentation of process parameters, and tracking process performance.

• On site technical support working closely manufacturing operations and quality assurance. Collaborate with Technical development teams to investigate major or critical deviations.

• Process SME for clinical drug product manufacturing.

• Assist with aseptic filling validation activities to ensure Modernas aseptic filling operations meet all current regulatory requirements and guidelines.

• Lead change control projects for clinical products and projects

Heres What Youll Bring to the Table:

• Biochemical engineer, Chemical engineer, or Biology Professional with a BS and over 8 years of experience, or MS with over 5 years in a pharmaceutical or biotechnology company.

• Expertise in sterile manufacturing operations. Demonstrated experience in technology transfer and technical support of sterile processes.

• Prior experience providing technical support in a cGMP manufacturing environment.

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

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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