Scientist - TS/MS Parenteral

Role Summary

The Scientist – TSMS PAR focuses on delivering parenteral operations, including technical transfer and process validation, with potential involvement in formulation, filling, or visual inspection. After start of commercial production, the role maintains validated processes, monitors metrics to ensure process capability and control, harmonizes control strategies across teams, identifies process improvements, and acts as an escalation point for day-to-day operations. The position develops and implements a technical agenda, provides technical leadership for the Parenteral Process Team, and mentors the TSMS team while engaging in upstream and external parenteral manufacturing activities.

Responsibilities

• Support the assigned Process Team (formulation, filling, or VI) as TSMS representative.
• Serve as floor-level support and technical interface for manufacturing components, equipment, and operations for the TSMS team.
• Represent Concord TSMS team for internal and external communications on a regular basis.
• Lead risk management activities as it pertains to product/process.
• Provide technical support to non-routine investigations (e.g., deviation, complaint), including consultation on quality and stability issues.
• Prepare and review or approve relevant technical documents (Annual Product Reviews, Change Controls, Regulatory Submissions, Deviations, Validations, Procedures, PFDs, PFMEAs, etc.).
• Develop, monitor, and respond to statistically based metrics in real time to assess process variability and capability.
• Identify opportunities and lead technical projects to improve process control and/or productivity.
• Serve as interface with upstream suppliers and parenteral product networks.
• Drive stability strategy for Concord products.
• Provide audit support as needed.
• Identify opportunities and participate in projects to improve process control and/or productivity.

Qualifications

• Required: Bachelor's degree or higher in engineering, packaging science, or related field.

Skills

• Pharmaceutical and/or medical device manufacturing experience.
• Root Cause Investigation experience.
• Proficiency with Microsoft Office, Veeva Vault, TrackWise, electronic batch records, and SAP.
• Demonstrated leadership of cross-functional teams.
• Strong interpersonal and teamwork skills.
• Strong self-management and organizational skills.

Additional Requirements

• Role is Monday through Friday with flexibility to support production schedules, shutdowns, and other inputs. Occasional extended hours or off-hour work may be required.