Engineer III, Process Development

About the role

Moderna is seeking a highly skilled and motivated Individual to join the Technical Development organization in Norwood, MA. The role involves supporting the development of manufacturing processes for Moderna’s mRNA-based medicines, with a focus on process understanding and process control strategy definition.

Responsibilities

• Serve as a technical SME for RNA manufacturing processes (e.g. IVT, purification) and translate processes into detailed functional and technical requirements for automated systems.
• Participate in the development of process flow diagrams (PFDs), P&IDs, User Requirement Specifications (URS), and Functional Requirement Specifications (FRS) for Drug Substance of manufacturing systems.
• Support the design, scale-up, and implementation of modular and small-scale process skids in alignment with GxP requirements and Moderna’s global standards.
• Partner with engineering, automation, and equipment vendors to design novel manufacturing platforms that enable closed and continuous operations that meet performance, safety, regulatory, and data integrity requirements.
• Contribute to Clean-In-Place (CIP) system design and optimization, focusing on process safety, efficiency, and reliability.
• Contribute to technical reviews, design evaluations, and standardization initiatives under Moderna’s Technical Authority governance model.
• Ensure compliance with GxP/GMP regulations and Moderna’s quality and documentation systems.
• Support global site startup activities via tech transfer, process investigations and provide person-in-plant support may require domestic or international travel (up to 15% of working time).

Requirements

• BS or MS in chemical engineering, biological engineering, chemistry, biochemistry, or closely related field
• BS with 5+ years, or MS with 2+ years of relevant industry experience in bioprocess development, pharmaceutical development, or closely related area
• Hands-on experience with chromatography, ultrafiltration, normal flow filtration, and/or development of innovative unit operations or experience in nucleic acid drug development (DNA, RNA, oligonucleotides) and/or nanoparticle delivery
• Experience in designing, executing, and analyzing scientific experiments
• Proven ability to support process design and equipment specification in a regulated manufacturing setting

Qualifications

• Experience in technology transfer and optimization of manufacturing processes
• Familiarity with bioprocess skid design, automation, and process analytical technologies (PAT)
• Experience supporting or leading cross-functional technical projects
• Exposure to personalized medicine or individualized manufacturing processes
• Certifications/Training: GxP/GMP compliance training, Strong understanding of FDA, EMA, and ICH regulations, Strong communication and collaboration skills across functional teams and organizational levels, Demonstrated ability to manage multiple technical priorities within a fast-paced, matrixed environment, Proven problem-solving and analytical skills to identify and resolve complex technical issues, Commitment to data integrity, safety, and quality excellence in all work activities

Benefits

At Moderna, we offer best-in-class healthcare coverage, voluntary benefit programs, family planning benefits, generous paid time off, savings and investment opportunities, and location-specific perks and extras. The salary range for this role is $89,900.00 - $143,800.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.

Pay & Benefits

The salary range for this role is $89,900.00 - $143,800.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.