Sr. Manager, Process Development

The Role:

The Pilot Scale Operations team is seeking a highly skilled and motivated full-time Senior Manager to lead nucleic acid pilot-scale production team. Pilot Scale Operations team is responsible for scale-up of process from bench scale to pilot scale and for generation of material at medium to large quantities for developmental and tox studies. Qualified candidates should be a technical SMEs in bioprocessing unit operations such as chromatography, enzymatic reaction, and tangential flow filtration. Candidate should have experience with scale-up and technology transfer of these unit operations. A successful candidate should have experience in large and small-scale equipment maintenance and troubleshooting; as well as authoring and updating equipment specific SOPs. This position will require excellent communication and organizational skills, as well as a focus on operational excellence and process optimization.

In addition to technical proficiency, this role requires strong people management skills. The Senior Manager will be responsible for hiring, onboarding, conducting performance reviews, and providing career development guidance. The Senior Manager will foster a positive and inclusive team culture, promote cross-functional collaboration, and represent the team in leadership meetings. They will drive operational excellence and process optimization, balancing team needs with organizational goals. Excellent communication, organizational skills, and the ability to lead people and projects in a dynamic, fast-paced environment are essential.

Here’s What You’ll Do:

• Lead and manage team of development scientists/ engineers and manufacturing associates responsible for transfer, preparation and execution of the batches/experiments in the pilot lab setting.

• Oversee lab operations and batch executions in accordance with the schedule. Guide team in troubleshooting issues on the floor in real time to ensure success of the batch/experiment.

• Be the receiving unit for technology transfer from Moderna’s Process Development teams, focusing on Nucleic Acid sciences, including DNA and mRNA

• Oversee operation, maintenance, and trouble shooting of reaction, tangential flow filtration and chromatography skids and other processing equipment (AKTA and Axichrom)

• Lead experiments to confirm robust process performance

• Demonstrate and implement GLP-enabling best practices including SOPs and documentation.

• Manage team resources, delegate tasks, and ensure team members are well-trained and supported.

• Assist Pilot Development Lab and technical teams with project goals, resourcing, and scheduling

• Practice safe work habits and adhere to Moderna safety procedures and guidelines

• Adhere to documented waste handling procedures to respect environmental regulations

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

Minimum Qualifications

• Degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Biochemistry, Biology, or related technical discipline

• BS with 10+ years experience, MS 8+ years experience, or PhD 4+ years experience in relevant industry.

• Hands-on experience with chromatography, tangential flow filtration, normal flow filtration, and enzymatic reactions

• Demonstrated success in bioprocess development and scale-up, technical problem solving, and tech transfer

Preferred Qualifications

• Over 2 years of direct people management and leadership experience

• Proven leadership and people management skills, with a track record of developing and leading high-performing teams

• Knowledge of Nucleic Acids and Pharmaceutical Development

• Strong communication skills as you will be responsible for having multiple interactions across operating and development teams

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