Technical Services Scientist
Location: Greenville, SC
Schedule: MondayFriday, 8:00 AM 5:00 PM (some overtime expected)
Work Environment: Approx. 20% of time on the manufacturing floor
Employment Type: Direct Hire
Salary: $100,000 $110,000 per year Relocation assistance offered
Job Summary: This role provides technical expertise in pharmaceutical process development, scale-up, and product transfer activities to support commercial manufacturing operations. The Technical Services Scientist works cross-functionally to ensure safe, compliant, and efficient production processes, with a focus on continuous improvement and technical problem-solving.
Key Responsibilities:
- Support the compliant manufacturing of commercial pharmaceutical products under cGMP guidelines.
- Develop, define, and optimize pharmaceutical manufacturing processes, including scale-up, tech transfer, and process improvement initiatives.
- Troubleshoot operational issues and recommend corrective actions to improve manufacturing performance.
- Create, revise, and issue Master Batch Records (MBRs), SOPs, and documentation related to process, equipment, and cleaning activities.
- Investigate deviations and non-conformances in manufacturing and packaging; propose and implement corrective and preventive actions (CAPAs).
- Participate in or lead process enhancements, equipment validations, and implementation of new or improved systems.
- Support demonstration, pilot, and scale-up batch manufacturing activities.
- Identify and propose improvements in process efficiency, equipment utilization, and operational workflows.
- Conduct training sessions for operations personnel, including the creation and delivery of technical training materials.
- Review executed batch documentation and ensure compliance with internal and regulatory requirements.
- Collaborate with cross-functional teams including Quality Assurance, Validation, Quality Control, and Supply Chain to support overall manufacturing success.
- Perform other duties as assigned in support of technical operations and continuous improvement.
Education & Experience Requirements:
- Bachelor's degree in a technical field (e.g., Chemistry, Biology, Engineering) or equivalent experience required.
- Minimum of 7 years of experience in pharmaceutical manufacturing
- Product development and product formulation industry experience required
- Experience with oral liquid pharmaceutical products is preferred but not required.
Skills & Abilities:
Strong understanding of cGMP, pharmaceutical regulations, and manufacturing documentation practices.
Ability to interpret technical literature, scientific journals, and regulatory documentation.
Proficient in troubleshooting complex technical and process-related problems.
Advanced math skills including statistical analysis, variance analysis, and data interpretation.
Strong communication skills with the ability to interact with regulatory agencies and internal stakeholders.
Ability to manage multiple tasks and operate effectively in a cross-functional team environment.
Capable of working with technical instructions in various formats, including diagrams and mathematical models.