Principal Research Associate / Scientist, Sterile Technology

Principal Research Associate / Scientist, Sterile Technology

The Role:

We seek a highly skilled and motivated Principal Research Associate/Scientist to work in a team developing lyophilized mRNA-Liposome formulations and fill/finish processes that enable late stage clinical development. Applicants should have experience in freeze/thaw and lyophilization development. The incumbent will also support the development of aseptic fill/finish unit operations through the development of scale-down models, process characterization studies etc. This requires exceptional project management, leadership, collaboration, communications skills with a strong attention to details, and a bility to work in a fast-paced, interdisciplinary environment. This position has significant visibility and potential for growth in a dynamic team. The successful applicant will work closely with scientists and engineers in Moderna's Process and Analytical Development Departments.

Here's What You'll Do:

• Assist in technology selection and evaluation for the unit operations related to Sterile Product Technology.
• Develop scale-down models for aseptic process unit operations.
• Perform bulk freeze/thaw formulation and process development studies, as well as connect to lyophilized product development, ensuring long-term stability of the bulk and final drug product.
• Support the implementation of bulk freeze/thaw technology at scale.
• Conduct studies to support scale-up of drug product manufacturing (e.g. freeze/thaw, mixing, filling, filtration, lyophilization, transport etc).
• Develop protocols to evaluate the compatibility of the drug product with processing materials, container closure components, and sterilization processes.
• Summarize the development results with tech reports.
• Provide support to drug product formulation innovation efforts.
• Support Analytical Development teams to develop methods and studies that pertain to the development of late-stage sterile products.
• Support manufacturing for process trouble-shooting and investigations.
• Author and review technical protocols, reports, product impact assessments, and regulatory sections as required in support of IND and marketing application submissions.

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

• BS/MS/PhD in Biochemical Engineering, Chemical Engineering or related Scientific/Engineering field
• Experience: 0 to 1 years post-Doctoral Degree or 2 to 8 years post Master's Degree or 5 to 10 years post Bachelor's degree. Experience in BioPharmaceutical, or Biotechnology industry preferred
• Extensive experience with one or more of the following: parenteral formulation development, nanoparticle preparation/characterization, freeze/thaw and lyophilization process development, aseptic process equipment characterization and process scale-up.
• Extensive experience with analytical characterization techniques including HPLC, DLS, Particle sizing and counting, FTIR, DSC, KF, Freeze Drying Microscope(FDM), XRD, BET etc.
• Experience with process scale-up/scale-down and statistical design of experiments (DoE) and analysis.
• Knowledge of nucleic acid chemistry and biology is a plus
• Knowledge of technology transfer of FDA-regulated manufacturing processes
• Knowledge of current practices and trends in disposable sterile technologies.
• Knowledge of GMP regulations and GLP compliance, Process Validation/Qualification principles, and aseptic processing principles.
• Preferred: Experience with lipid nanoparticle formulations
• Preferred: Process tech transfer experience to internal/external manufacturing sites
• Preferred: Experience working with CMO
• Preferred: Experience with IND, BLA/MAA regulatory filings

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

• Daily on-site 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
• 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)

Why join Moderna

At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

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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.