Manufacturing Specialist

The Role
In this role, you will be part of a cohesive team responsible for producing high quality mRNA-based medicines for production specializing in Moderna’s Individualized Neoantigen Therapy. 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 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 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

May generate technical protocols and reports

May support internal and external audits

Work independently with mínimal supervision and direction

Additional duties as may be assigned from time to time

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

Bachelor's Degree with 5+ years of experience in biopharmaceutical operations or a Master’s Degree with 2-5 years industry experience; Degree in Engineering or Life Sciences is preferred

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

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

Understanding of investigational techniques such as Fishbone/Ishikawa analysis, 5-Why, Kepner Tregoe

Minimum of 2 years’ experience with Quality 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 mínimal 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 knowledge

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
- D iscretionary 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 parents
401k match and Financial Planning tools
Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
Complimentary concierge service including home services research, travel booking, and entertainment requests
Free parking or subsidized commuter passes
Location-specific perks and extras

About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization th