Sr. Engineer I, Process Development

The Role:
Moderna is working to develop first-in-class messenger RNA (mRNA) based medicines.  We are seeking an experienced Bioprocess scientist or engineer with a strong process development background in the regulated biopharmaceutical environment to reside in Moderna’s Technical Development organization in Norwood, MA. Our team’s goal is to envision, pilot, scale, characterize, transfer, and validate robust commercial GMP manufacturing processes. This is a lab and desk based role with possible supervisory responsibility for high‑performing junior team members. We seek applicants who are proactive, enthusiastic, and show a passion for process development.

The successful candidate must be able to work in a fast paced and highly dynamic environment, will have significant experience in biologics process development using standard bioprocess unit operations (e.g. reactions, mixing, chromatography, tangential flow and/or normal filtration, …), and will be able to contribute to both process development and commercialization related activities.

These skills should be complemented with a track record of effective troubleshooting, time management, strong communication and collaboration skills, and examples of leadership in process development. Success in this role would be demonstrated by the establishment of a validated PAI-ready manufacturing process.  This role requires close working relationships with Analytical, Manufacturing, Supply Chain, Quality, Regulatory and Program Management functions.

Here’s What You’ll Do:

• Develop robust, scalable and well-characterized processes for the manufacture of mRNA medicines using QbD principles

• Represent the mRNA process development group in cross-functional CMC program teams and translate project goals into actionable plans

• Manage and execute transfer of production processes from development labs to GMP facilities on rigid timelines

• Specify and support the procurement of materials and manufacturing equipment (possibly custom)

• Establish scale-down process models and perform process characterization utilizing DOE principles

• Author BLA content associated with process development and validation

• Ensure high quality source documentation is generated to support regulatory filings

• Prioritize work and leadership across multiple process development and manufacturing programs

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

• BS with a minimum of 9 years of experience, MS with a minimum of 7 years experience, or PhD with post-doctoral or industry experience in bioprocess development and/or manufacturing sciences. 

• Accomplished background in process development (late-phase preferred) and process technology transfer for large biomolecules using QbD principles (sender or receiver)

• Knowledge of the large molecule regulatory environment, particularly FDA/ICH/ISPE guidelines on risk management, technology transfer and process validation

• Exceptional leadership, prioritization and project management skills.

• Ability to effectively document and communicate results.

• Strong interpersonal skills with an eagerness to support colleagues across the organization and a demonstrated aptitude for team and employee development

• Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment

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