Process Scientist - TS/MS Lab - Lebanon API Manufacturing

Role Summary

Process Scientist - TS/MS Lab - Lebanon API Manufacturing. Responsible for designing and executing lab experimentation aimed to transfer processes, characterize processes, troubleshoot process upsets, and provide recommendations for process improvements within a small molecule-focused TS/MS team.

Responsibilities

• Complete laboratory experimentation aimed at achieving the successful process development and transfer
• Developing experimental studies to address process upsets in routine manufacturing
• Design and perform range finding studies to enable effective process characterization
• Identify potential for process optimization to improve yield and throughput
• Coordinate with TS/MS team to setup models to support manufacturing as required
• Accurately record data in accordance with TS/MS laboratory procedures
• Adhere to all Environmental, Health, and Safety standards
• Effective management of multiple projects
• Lead or perform in-depth investigations for out of specification results and aberrant data, conduct root cause analysis, and recommend solutions to prevent recurrence
• Communicate effectively in both written and oral formats
• Participate in internal/external audits as needed

Qualifications

• Required: Bachelor degree (4 year College) in a science field related to the lab (e.g., Chemistry, Biochemistry, Pharmaceutical Science). Advanced degree (MS or PhD) preferred but not required
• Required: 1+ year of laboratory experience in a cGMP environment
• Preferred: Experience with small molecule pharmaceutical development and characterization
• Preferred: Experience in API manufacturing
• Preferred: Understanding of cGMP and regulatory requirements
• Preferred: Experience with continuous processing, process characterization, transferring processes into GMP manufacturing, and chemical process safety/calorimetry

Skills

• Excellent communication skills, both oral and written
• Ability to independently master assigned processes and coordinate activities with internal and external partners

Education

• Bachelor degree in a science field; advanced degree (MS or PhD) preferred but not required