Sr. Scientist, Drug Product Development
ModernaTX, Inc.

The Role:

We are seeking a highly motivated Senior Scientist/Engineer to join our Drug Product Development (DPD) team in Norwood, MA. This candidate will be the opportunity to not only impact the technical progression of Moderna's exciting pipeline but also to provide team leadership. From pre-clinical through commercialization, DPD is accountable for:

• Product image definition

• Formulation development

• Aseptic process development and characterization

• Container selection and compatibility/CCI evaluation

• Process scale up

• Technology transfer

The DPD team's focus is on the development, characterization, and implementation of robust clinical/commercial manufacturing processes to enable the production and distribution of life saving products. While operating as an end-to-end DPD lead, this role will also have a specific focus on clinical engagement and optimization of in-use stability approaches.

Here's What You'll Do:

Lead matrixed Drug Product teams to advance formulation development, fill/finish process development, process characterization, technology transfer, and regulatory authoring for our mRNA portfolio candidates

Interface closely with Clinical Operations and Early Development organizations to execute and support clinical in-use characterization studies and related documentation

Collaborate with key stakeholders (Clinical Operations, Early Development, Research, Quality, Compliance, Analytical, etc.) to define and optimize in-use strategy

Design and execute detailed experiments using appropriate scale down models, QbD principles, and process characterization/modeling techniques to develop and troubleshoot specific unit operations.

Provide technical mentorship to junior scientists/engineers in all aspects of parenteral drug product development and aseptic processing

Advance platform and DPD functional initiatives through direct contributions and matrixed leadership

Support authoring and review of regulatory submissions

Here's What You'll Bring to the Table:

• Degree in Chemical/Biomedical Engineer, Pharmaceutical Sciences, Biochemistry, or related discipline
  
• Minimum of 4 years (PhD), 8 years (MS), 10 years (BS) industry experience in biopharmaceutical development
  
• Demonstrated experience with clinical in-use studies, pharmacy manual authoring, dose handling considerations, and product image (container, volume, etc.) design
  
• Experience in parenteral Drug Product development and commercialization
  
• Prior management and mentorship experience
  
• Ability to work independently and as part of a team in a highly dynamic, fast-paced, matrixed environment with rapidly evolving priorities
  

Here's What We'll Bring to the Table:

• On-site subsidized cafeteria or catered lunches
• Company-provided iPhone
• Free parking, monthly subway pass or a subsidized commuter rail pass
• Free annual corporate membership to Bluebikes
• Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
• Flexible Spending Accounts for medical expenses and dependent care expenses
• 16 weeks of 100% paid parental leave for all new parents
• 16 weeks 100% paid family caregiver leave
• 20 weeks 100% paid medical leave
• Eligible for "Moderna Month" (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
• Adoption assistance and discounts to local childcare centers, as well as access to care.com
• 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
• A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
• Voluntary legal assistance plan
• 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)

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 10 years since its inception,Modernahas transformed from a science 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 six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed.Modernamaintains 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 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 auto-immune diseases.Modernahas been named a top biopharmaceutical employer bySciencefor 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.

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