Position Overview

Our client is seeking an experienced Technical Services/Manufacturing Sciences (TS/MS) Process Scientist to provide hands-on technical support within an active pharmaceutical manufacturing environment.

This role is designed for a scientist who has spent significant time embedded within live manufacturing operations and owned a process or product line over time. The Process Scientist will serve as a key resource for manufacturing personnel, providing on-floor troubleshooting, investigating manufacturing events, supporting process execution, and maintaining ownership of manufacturing processes.

The ideal candidate has supported commercial or scale-up manufacturing operations on an ongoing basis and understands the day-to-day ownership required after a process has been implemented.

Key Responsibilities

Manufacturing Floor & Process Support

• Serve as an embedded resource supporting active manufacturing operations.
• Provide hands-on guidance to operators and manufacturing personnel during production.
• Maintain sustained ownership of assigned manufacturing processes and/or product lines.
• Troubleshoot process issues and respond to unexpected events occurring during manufacturing.
• Evaluate process performance and provide scientifically sound recommendations to Manufacturing and Quality.
• Recognize when manufacturing issues require escalation and engage the appropriate technical, quality, engineering, or leadership resources.
• Support implementation and execution of downtime discard policies.

Deviations, CAPA & Technical Investigations

• Lead or directly support deviation investigations resulting from actual manufacturing-floor events.
• Perform root cause analysis and develop technically sound corrective and preventive actions (CAPAs).
• Partner with Manufacturing and Quality to assess process and product impact following deviations.
• Monitor CAPA effectiveness and support implementation of improvements within manufacturing operations.
• Use manufacturing data, process knowledge, and direct floor observations to support investigations rather than functioning solely as a documentation resource.

Batch Records, Specifications & Process Ownership

• Own, review, and revise batch records, manufacturing instructions, specifications, and other process documentation supporting commercial or scale-up production.
• Ensure manufacturing documentation accurately reflects established process requirements and technical knowledge.
• Support changes to manufacturing processes, specifications, and production documentation through appropriate change-control processes.
• Maintain technical knowledge of assigned processes throughout their lifecycle.

Process Validation & Technical Studies

• Generate, review, and execute Performance Validation (PV) protocols and other manufacturing process studies.
• Assist with development of technical protocols supporting process validation and manufacturing activities.
• Design and/or execute studies such as mixing studies to evaluate formulation homogeneity.
• Support acclimation studies assessing material stability following environmental changes.
• Evaluate study data, document conclusions, and provide technical recommendations.

Cross-Functional Collaboration & Technical Leadership

• Maintain ongoing working relationships across Manufacturing, Quality, R&D, Regulatory, Engineering, and other technical functions.
• Serve as a technical subject matter resource for manufacturing personnel.
• Train and mentor scientists, technicians, and/or manufacturing operators on processes, technical requirements, and troubleshooting.
• Communicate technical issues and recommendations effectively to both technical and operations personnel.
• Support knowledge transfer and continuous improvement across the manufacturing organization.

Required Qualifications

• Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or another relevant scientific or technical discipline.
• 5+ years of relevant pharmaceutical or biopharmaceutical manufacturing experience preferred.
• Demonstrated experience providing sustained, hands-on technical support within live manufacturing operations.
• Experience owning or supporting a manufacturing process or product line through ongoing commercial or scale-up production.
• Direct experience investigating manufacturing deviations and supporting CAPA development and execution.
• Experience owning, authoring, or revising batch records and/or product/process specifications associated with manufacturing.
• Experience generating and executing process validation or manufacturing study protocols.
• Strong process troubleshooting and root cause analysis capabilities.
• Demonstrated ability to work cross-functionally with Manufacturing and Quality.

Preferred Qualifications

• Experience within Technical Services/Manufacturing Sciences (TS/MS), Manufacturing Science and Technology (MSAT/MS&T), Process Sciences, Process Engineering, or a comparable manufacturing technical support function.
• Experience supporting formulation, filling, and/or visual inspection operations.
• Experience designing or executing mixing, homogeneity, acclimation, hold-time, or other process characterization studies.
• Experience training or mentoring scientists, technicians, and/or manufacturing operators.
• Experience working directly with R&D and Regulatory in addition to Manufacturing and Quality.
• Experience supporting commercial pharmaceutical production in a 24/7 manufacturing environment.