Scientist - TS/MS Parenteral

Role Summary

The Scientist – TS/MS Parenteral focuses on parenteral operations, specifically technical transfer and process validation. The role supports formulation, filling, or visual inspection (VI) during start-up and, upon commercial production, maintains validated processes, monitors metrics, harmonizes control strategies, and leads process improvement. The position develops and implements a technical agenda, provides technical leadership for the Parenteral Process Team, mentors the TSMS team, and engages in upstream and external activities related to parenteral manufacturing.

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, as required, relevant technical documents such as 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 computer systems including Microsoft Office products, Veeva Vault, TrackWise, electronic batch records, and SAP.
• Demonstrated successful leadership of cross-functional teams.
• Strong interpersonal and teamwork skills.
• Strong self-management and organizational skills.

Additional Requirements

• Role is Monday through Friday. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and/or off-hour work may be required.