Sr. Engineer I, Drug Product Development

The Role:

Moderna is seeking a highly skilled and motivated Senior Engineer to join our Drug Product Development (DPD) team in Norwood, MA, to support development of Moderna’s device combination products. The primary role for this position will be to support drug product development activities including: device development, combination product development and packaging development. Specifically, the applicant will be responsible for Human Factors Engineering activities related to Moderna’s combination products. Applicants should have relevant device engineering related experience in the pharmaceutical space. 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:

• Lead human factors engineering activities on drug delivery device technology development and/or drug-device combination product programs.

• Be involved in problem solving and utilization of different strategies to support resolution of design, risk and regulatory challenges.

• Help establish and develop of human factors engineering strategies for drug delivery combination product.

• Ensure user needs are considered early and continuously throughout the design process.

• Manage and support the execution of early patient handling studies, identify and maintenance of user needs, conduct user related risk assessments and perform ethnographic analysis.

• Plan and support the execution of design validation studies.

• Author and/or provide oversight to human factors documents for device and combination product design history files.

• Interacting with external human factors vendors and senior leaders with regards to human factors strategy and implementation.

• Assist in platform device and packaging design and development identifying ways improve platform efficiency.

• Support the team by managing action plans and project plans to deliver short-, mid- and long-term development goals.

• Effectively communicate your work to the wider development team and stakeholders.

• Manage external vendors or partners as required to advance project milestones.

• Provide mentorship to junior scientists/engineers to develop appropriate internal capability.

• Maintain accountability for project success and results delivery.

• Support authoring and review of regulatory submissions and written responses.

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

• BS (8+ years), MS (5+ years) or PhD in Human Factors/Systems/Biomedical Engineering, Pharmaceutical Sciences, Biochemistry or related scientific disciplines with industry experience in small and/or large molecule combination drug product development.

• Exceptional laboratory skills and hands-on experience with aseptic liquid filling and handling of vials, pre-filled syringes, and/or cartridges. Familiar with current varieties and suppliers of parenteral container closure systems.

• Experience in clinical or commercial Drug Product (or related) GMP technology transfer and validation would be a plus.

• Ability to perform data analysis using advanced statistical, including design of experiments (DoE) approaches leveraging statistical analysis software

• Experience working in matrix project teams with members from peer groups, CMC teams, R&D, CMOs and CROs.

• Knowledge of GMP and GLP 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 optio