Engineer I, Drug Product Development

The Role:

We are seeking a highly skilled and motivated Research Associate / Engineer I in Drug Product Development, to work in a team developing Moderna’s sterile drug product processes and products that enable clinical and future commercial supply. The primary role for this position will be to support product concept development including process development and scale-up work, container development and conditions of use studies. The incumbent will support the development of compositions, aseptic fill/finish unit operations through the development and use of scale-down models, process characterization studies etc. Applicants should have relevant pharmaceutical sciences related experience with various aspects of drug product development. The applicant should have exceptional ability to plan, execute and report, to communicate and collaborate, and requires strong attention to detail while working in a fast-paced, interdisciplinary environment.

Here’s What You’ll Do:

• 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.

• Provide support to drug product development activities executed in collaboration with Moderna’s Pilot organization, including toxicology fills stability fill operations.

• Plan, organize and execute experiments (using DoE where possible) – prepare study protocols and summarize the development results with presentations and study reports.

• Communicate and collaborate with various groups such as analytical development to execute experiments and compile data.

• Support manufacturing with studies for process trouble-shooting and investigations.

• Perform a range of routine and non-routine characterization techniques, including opacity testing, microscopy, particle sizing etc.

• Develop processes suitable to ensure long-term stability of vialed drug product.

• Maintain an up-to-date ELN with good documentation practices

• Closely collaborate with multiple groups to generate innovative solutions to challenging formulation and process problems.

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

• Education Qualifications - Masters or Bachelor’s Degree in on one of the following fields: Chemical Engineering, Biochemical or Biomedical Engineering, Pharmaceutical Sciences, or any related or sub-disciplines of the above.

• Relevant Experience: 0 – 2 years post Master’s Degree or 0 – 4 years post Bachelor’s Degree.

• Exceptional laboratory skills with ability to work efficiently and productively in a highly dynamic environment

• Knowledge of statistical design of experiments (DoE) and analysis

• Knowledge of nucleic acid chemistry and biology is a plus

• Preferred: Experience in BioPharma, BioPharmaceutical, Pharmaceutical, or Biotechnology industry

• Preferred: Experience with nanoparticle formulation technology

Preferred: Knowledge of GMP compliance

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!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delive