Technical Service Scientist II

About the role

The Technical Services Scientist II (Commercial Support) provides technical support for approved commercial liquid pharmaceutical manufacturing operations. This role supports process optimizations, internal and external technology transfers, process troubleshooting, investigations, GMP documentation, and validation activities.

Responsibilities

• Provides technical support as related to commercial manufacturing of oral liquid pharmaceutical drug products.
• Works under moderate supervision, demonstrating efficient, effective, and proficient ability to:
• Perform troubleshooting and investigating process and equipment-related issues.
• Perform optimizations of manufacturing processes and applicable procedures.
• Gather, analyze, and communicate outcomes of historical data to support investigations.
• Oversee exhibit and scale-up batch manufacturing, technology transfer, and equipment trials for commercial products.
• Lead the modification, enhancement, and qualification of new and existing processes, equipment, and procedures.
• Aid in the execution of validation protocols and data collection.
• Execute generated protocols.
• Generate and review Manufacturing Batch Records (MBRs), Protocols/Reports, SOPs, and documentation to support submissions (Common Technical Document (CTD) sections with justifications).
• Supports safe and compliant pharmaceutical manufacturing processes.

Requirements

• Demonstrates foundational knowledge and basic understanding of pharmaceutical manufacturing processes.
• Demonstrates attention to detail and commitment to accuracy and quality.
• Demonstrates ownership and accountability for assigned tasks and minor decisions.
• Follows technical instructions and documentation.
• Demonstrates decision-making ability using basic problem-solving and structured logic.
• Proficient in basic mathematics.
• Communicates clearly and effectively, both verbally and in writing.
• Bachelor’s degree in Engineering, Chemistry, Biology, or related technical discipline preferred.
• 4-10 years of pharmaceutical manufacturing or technical operations experience.
• Oral liquid manufacturing experience preferred.
• cGMP knowledge preferred.

Qualifications

• Ability to stand, walk, and move throughout laboratory, pilot plant, and manufacturing environments for extended periods of time.
• Ability to lift, carry, push, and pull materials and equipment up to 30 pounds routinely and up to 50 pounds occasionally, with or without reasonable accommodation.
• Ability to bend, stoop, kneel, crouch, climb, and reach as required to access equipment, materials, and work areas.
• Manual dexterity sufficient to operate laboratory and manufacturing equipment, tools, computers, and documentation systems.
• Ability to visually inspect materials, equipment, batch records, and process operations with close attention to detail.
• Ability to wear required personal protective equipment (PPE) including but not limited to: Safety glasses Gloves Lab coats, gowns, hair/beard covers Respirators (if required by task).
• Ability to work in controlled manufacturing and laboratory environments that may include: Temperature variations Noise Humidity.
• Must be able to work a full shift (40+ hours/week as business needs require), including extended hours during scale-up, tech transfer, or regulatory support activities.