Senior Deviation Specialist

The Role:

Reporting to the Senior Manager/Associate Director, Manufacturing, this individual will be part of a cohesive team responsible for producing high quality mRNA-based medicines for production specializing in Moderna’s Individualized Neoantigen Therapy.  The Manufacturing Sr. Specialist uses expert knowledge of cGMP regulations and biopharmaceutical production processes to support projects as well as day to day operations through deviation and CAPA writing with a focus on but not limited to DNA, mRNA, or Fill Finish Operations.  The Sr. Specialist will be a key player during Marlborough operational readiness efforts by supporting startup activities, investigating issues that arise, and driving projects within the team focused on delivering results in an efficient manner. This position will be M-F, with occasional tasks outside of working hours to support 24/7 operations.

Here’s What You’ll Do:

• Practice and promote safe work habits and adheres to safety procedures and guidelines

• Utilize manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues, deviations, non-conformances, and unexpected events

• Lead cross functional teams to drive complex investigation close outs, determine root causes and implement appropriate corrective and preventive actions (CAPA)

• Conduct document revisions and/or document management including batch production records and manufacturing procedures

• Participate in additional user forums for gathering ongoing requirements and prioritization and triage issues

• Follow-up on requests, issues, and projects and report statuses to manager/ working teams

• May perform metric trending

• Generate technical protocols and reports

• Support internal and external audits

• Work independently with minimal supervision and direction

• Perform work that consistently requires independent decision making and the exercise of independent judgment and discretion

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

• Bachelor's Degree with 8-10 years of experience in biopharmaceutical operations or a Master’s Degree with 5+ years industry experience; Degree in Engineering or Life Sciences is preferred

• Subject matter expertise in biologics drug substance purification operations (liquid chromatography, TFF, aseptic technique), drug product operations or a similar complex specialized environment

• A comprehensive understanding of investigational techniques such as Fishbone/Ishikawa analysis, 5-Why, Kepner Tregoe

• A comprehensive understanding of regulatory requirements and their applications in a cGMP environment

• Minimum of 2 years’ experience with deviation/investigation management systems or a similar technical writing system in a cGMP environment

• Excellent written and oral English language skills

• Demonstrated ability to lead cross functional teams and deliver results with minimal supervision

• Ability to manage multiple competing priorities in a fast-paced environment

• Experience working with electronic batch records and thorough understanding of 21 CFR part 11 requirements

• Background in lean manufacturing methodologies and operational excellence

• Experience interacting with representatives of regulatory agencies

• Project management experience

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 yo