CON TSMS Process Scientist 2026

Eightelevengroup; Concord (NC); On-site; USD 95,000 - 135,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) with company match

Paid time off

Job summary

Medasource is seeking a Technical Services/Manufacturing Sciences (TS/MS) Process Scientist for an embedded role in Concord, NC. The candidate will provide hands-on technical support on the manufacturing floor, own processes and batch records, and troubleshoot events in a live production environment.

The role emphasizes deviation investigations, CAPA development, process validation studies, and cross-functional collaboration with Manufacturing, Quality, and R&D to sustain product quality and

Qualifications

• 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.

Responsibilities

• Embed as a hands-on resource for active manufacturing operations.
• Provide on-floor guidance to operators during production.
• Maintain ownership of assigned manufacturing processes and product lines.
• Troubleshoot process issues and respond to unexpected events during manufacturing.
• Support deviation investigations and CAPA development with root cause analysis.
• Manage batch records and process documentation; support change-control processes.
• Assist with process validation protocols and related technical studies.

Skills

Hands-on troubleshooting

Live manufacturing operations

Process ownership

Deviations & CAPA

Cross-functional collaboration

Education

Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or another relevant scientific or technical discipline

Job description

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.

CON TSMS Process Scientist 2026 Concord, North Carolina

Medasource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

Benefits & Perks

• Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs.
• We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays.
• We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.

Pay Disclaimer

The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.