Sr. Manager, Manufacturing

The Role

In this role, you will be responsible to lead a team of specialists and associates focused on daily operations as well as ensuring manufacturing readiness, batch closeout, and continuous improvement initiatives for the INT Manufacturing team.  They will hire, train, develop and retain a high-performing, flexible team capable of driving a fast-manufacturing operation timeline.  This individual is a key contributor to technology transfer and capacity expansion efforts, working with (and leading) cross-functional teams.

Here’s What You’ll Do

• Lead a team of Specialists to support manufacturing of DNA plasmid, mRNA DS or mRNA DP for phase III and eventual commercial launch of our therapeutics.

• Lead a team of Manufacturing Associates to ensure operational excellence and schedule adherence.

• Oversee the hiring, training, development, retention, and performance of manufacturing & specialist staff.

• Manage and execute a portfolio of projects, working and leading in a cross-functional matrix environment.

• Lead cross-functional teams to drive complex investigations, determine root causes, and implement appropriate CAPAs.

• Ensure on-time completion of CAPAs, Change Controls, Deviation Investigations, and other Quality System elements for the DNA Manufacturing organization.

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

• Drive operational readiness for new product introductions and technology transfers, including elements such as SOPs, Work Instructions, Batch Records, etc.

• Leverage Lean and Six Sigma principles to foster and drive a culture of continuous improvement.

• Additional duties as may be assigned from time to time

Here’s What You’ll Need (Basic Qualifications)

• A BS in engineering or sciences and 8+ years of experience in all manufacturing processes in a pharmaceutical or biotechnology environment, or 12+ years with proven direct experience. In role.

• Previous Supervisory and/or Project Management experience is required.

• This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.

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

• Experience with cell culture / fermentation operations is preferred.

• 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).

• Technical writing skills and proficient in investigations and root cause analysis.

• 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).

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

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 paren