Job Description

Position Summary

The TSMS Process Scientist is responsible for supporting the technical delivery and validation of parenteral operations, focusing on formulation, filling, or visual inspection (VI). This role supports technical transfer, process validation, and transition into commercial production while ensuring ongoing process capability and control. The scientist will serve as a technical leader within the TSMS team and provide expertise during both start-up and routine operations.

For senior and principal levels, additional responsibilities include mentoring junior team members and engaging with external stakeholders.

Key Responsibilities & Deliverables

• Support assigned parenteral process area (formulation, filling, or VI) as the TSMS representative.
• Serve as the technical interface for manufacturing equipment, components, and operations.
• Provide floor-level technical support during manufacturing operations and issue resolution.
• Lead or support non-routine investigations (e.g., deviations, complaints) and provide quality/stability consultation.
• Prepare, review, or approve technical documents such as:
• Annual Product Reviews
• Change Controls
• Regulatory Submissions
• Deviations
• Validation Protocols/Reports
• SOPs, PFDs, PFMEAs
• Lead risk management and process improvement initiatives.
• Develop and monitor real-time, statistically-based metrics for process control and capability.
• Drive stability strategy and harmonize control strategies across teams.
• Collaborate with upstream suppliers and the broader parenteral product network.
• Provide audit support and represent the Concord TSMS team in internal and external communications.

Principal-level responsibilities also include:

• Mentoring TSMS team members and engineers.
• Representing the Concord site in cross-site and upstream engagements.

Basic Qualifications

Education:

• Bachelor’s degree or higher in Engineering, Packaging Science, or a related scientific field.

Experience:

• 2+ years in cGMP manufacturing (validation, TSMS, QA, engineering, operations, etc.)

Preferred Skills & Experience

• Background in pharmaceutical and/or medical device manufacturing
• Experience with root cause investigation methodologies
• Proficiency with:
• Microsoft Office
• Veeva Vault
• TrackWise
• Electronic Batch Records
• SAP
• Demonstrated success in leading cross-functional teams
• Strong interpersonal, organizational, and self-management skills

Additional Information

• Schedule: 12-hour shifts, 2-2-3. 6AM-6PM or 6PM-6AM.

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