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Job Details

Skills

SAP BASIS
Embedded Systems
Quality Assurance
Leadership
Documentation
Change Control
Collaboration
IT Management
Knowledge Transfer
Continuous Improvement
Chemistry
Biology
Manufacturing Operations
Management
Corrective And Preventive Action
Root Cause Analysis
IT Service Management
Science
Process Engineering
Technical Support
Inspection
Training
Mentorship
Research and Development
Pharmaceutics
Manufacturing

Summary

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.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10110651A
Position Id: a1Wcv000000vr61EAA
Posted 2 hours ago

Company Info

About Medasource

Mission
We’re on a relentless pursuit to provide unmatched experiences for our consultants and customers in the healthcare consulting field.

Vision
We aim to grow with purpose meaningfully. Our company vision is simple: Improving Partnerships to Deliver Unmatched Quality.

We empower our consultants and employees to always be accountable, never stop learning, and take ownership of our mutual success through servant leadership and unhindered curiosity.

Job Details

Skills

SAP BASIS
Embedded Systems
Quality Assurance
Leadership
Documentation
Change Control
Collaboration
IT Management
Knowledge Transfer
Continuous Improvement
Chemistry
Biology
Manufacturing Operations
Management
Corrective And Preventive Action
Root Cause Analysis
IT Service Management
Science
Process Engineering
Technical Support
Inspection
Training
Mentorship
Research and Development
Pharmaceutics
Manufacturing

Summary

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.

Dice Id: 10110651A
Position Id: a1Wcv000000vr61EAA
Posted 2 hours ago

Company Info

About Medasource

Mission
We’re on a relentless pursuit to provide unmatched experiences for our consultants and customers in the healthcare consulting field.

Vision
We aim to grow with purpose meaningfully. Our company vision is simple: Improving Partnerships to Deliver Unmatched Quality.

We empower our consultants and employees to always be accountable, never stop learning, and take ownership of our mutual success through servant leadership and unhindered curiosity.

GMP Compliance Investigator

North Carolina

•

Today

GMP Compliance Investigator - Equipment & Facilities Overview Our client is seeking a GMP Compliance Investigator - Equipment & Facilities to support a GMP manufacturing laboratory focused on advanced cellular therapies. This individual will play a key role in maintaining compliance with FDA regulations and applicable accreditation standards by leading investigations, authoring quality documentation, and partnering closely with Manufacturing and Quality teams. This is a highly collaborative ro

Contract

$35.00 - $45.00

CON TSMS Process Scientist 2026

Skills

Summary

Dice Job Match Score™

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CON TSMS Process Scientist 2026

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Job Details

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Summary

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About Medasource

Dice Job Match Score™

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