Technical Specialist, Manufacturing, Clinical Drug Substance

The Role:

Clinical & Commercial Drug Substance Operations is responsible for the execution of processing and combining mRNA and LMX/LNP for clinical pipeline products as well as commercial seasonal vaccines in a GMP regulated environment. A Technical Specialist, Manufacturing uses fundamental and developing knowledge of manufacturing practices, bioprocess unit operations, process engineering and digital systems to act as a technical resource for the clinical and commercial drug substance manufacturing team.  They will, with guidance, participate in the development of operational procedures and training material, training manufacturing associates, supporting technology transfer activities, investigating issues that arise, and ensuring progress monitoring of projects.   

Here's What You’ll Do:

• Follow all relevant GMP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.

• Practice and promotes safe work habits and adheres to safety procedures and guidelines.

• Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions. 

• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.  

• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence of gowning and vision, if applicable. 

• Utilize the manufacturing support systems and equipment as required including, but not limited to, SAP, VEEVA, Delta V, Syncade, LIMS, CMMS.

• As a Qualified Trainer, perform On The Job Training (OJTs) for eBR review and unit operations as applicable.

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

• Support manufacturing unit operations to receive tech transfers and other projects.

• Support and participate in cross-functional teams to general manufacturing operation changes, improvements, and issue investigations.

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

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

• Responsible for timely equipment Out of Tolerance (OOT) response and closure.

• Support the investigation and own CAPA implementation for manufacturing deviations.

• Own and manage change controls for projects within the team.

• Own the purchasing and induction of simple equipment and tools.

• Participate in equipment start-up, commissioning, and validation activities.

• No approval or delegation authority with this role.

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

• Education: Degree

• Experience: STEM degree with 3-5 years’ industry experience or a Masters’ degree with 1-2 years’ industry experience

• Specific Certifications or Training: None 

• Other Quantifiable Preference:  Strong understanding of GMP regulations.

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 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 Mo