Supervisor, Manufacturing

The Role:

Moderna is seeking a Supervisor of Manufacturing, to build and lead a cohesive team responsible for manufacturing DNA Plasmid for our mRNA vaccines and therapeutics. This position is located at our location in Burlington, MA.  This position will be 12-hour night shift from 6:00 pm to 6:00 am, with a 3-2-2-3 rotating shift cadence.

The individual in this role will be a hands-on front-line leader, accountable for leading a team in support of a fast paced operation to deliver DNA Plasmid for our vaccine and therapeutic clinical candidates, with a focus on the Personalized Cancer Vaccine program. He/she will apply existing knowledge of bioprocess unit operations and cGMPs while learning the Moderna platform.  They will enable technical and operational success while keeping employee safety and product quality front of mind.  They will develop a high-performing, flexible manufacturing team capable of meeting a constantly evolving manufacturing operation timeline.

Here’s What You’ll Do:

• Ensure Safe and Compliant production of DNA Plasmid and associated intermediates

• Oversee the hiring, training, development, retention, coaching, and overall performance of staff for execution of manufacturing operations

• Provide on-the-floor coaching of the manufacturing team in execution of the process, troubleshooting, cGMPs, and safety practices

• Escalate and drive resolution to issues that may impact operational safety, product quality, or ability to produce

• Work with process SMEs to develop batch records, SOPs and training materials

• Ensure the training of staff and adherence to established procedures

• Establish and maintain a Quality Culture within your team

• Closely partner with QA peers for rapid disposition of batches, including ensuring timely batch record, protocol, and log reviews, deviation investigation support, etc.

• Own the investigation and CAPA implementation for Human Performance deviations

• Own and drive best-in-class shift handover practices (in partnership with the supervisors on either side of your schedule)

• Play a key role in leading ops readiness for new product introductions and technology transfers

• Maintain a flexible schedule based on the demands of production

• Monitor the achievement of business and financial goals, rapidly escalate when critical issues arise that impact our ability to meet those goals

• Collaborate cross-functionally with Technical SMEs (MS&T, PD, Process Eng), Facilities, Validation, Supply Chain, QA, and QC in order to meet business goals

Here’s What You’ll Bring to the Table (Minimum Qualifications):

• Requires BS in a relevant science or engineering discipline plus 5 years’ experience in a biotechnology manufacturing/quality/development environment; or an MS with 2-5 years’ experience; or 10+ years professional experience with 5 years’ being in a biotechnology manufacturing/quality/development environment.

• Previous Supervisory / Leadership experience is required

• Thorough knowledge and understanding of cGMPs

• Ability to lift 50 lbs

Preferred Qualifications:

• Subject Matter Expert on cell culture & gigaprep scale purification

• Excellent communication and presentation skills

• Strong leadership, collaboration, and team building skills

• Skill in conflict resolution and crucial conversations (within the team and between functions)

• Fluency in digital systems such as SAP, DeltaV, MES, etc.

• Experience in both traditional stainless-steel and single use systems

• Strong understanding of manufacturing supply chain systems, including production planning, scheduling, and material management

• Proven ability to assess risk and collaborate with support groups to develop suitable action plans and minimize potential impact

• Experience in cGMP inspections (with partner companies and/or regulatory agencies)

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 s