Technical Service Scientist II

TS Scientist II (Commercial Support)

The Technical Services Scientist II (Commercial Support) is a technical role responsible for providing support for approved commercial liquid pharmaceutical manufacturing operations. This position supports process optimizations (including scale up/down), internal and external technology transfers, process troubleshooting, investigations, GMP documentation, and validation activities under the direction of senior team members and management. This role focuses on execution, learning, and developing technical proficiency within a cGMP-regulated manufacturing environment.

No direct supervision responsibility. Provides guidance to entry-level TS members as needed.

Essential Duties & 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.
  • Assist with 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).
• Provides knowledgeable support and effective communication to cross-functional teams (Validation, QA, QC, Engineering, Operations, RA, and Supply Chain).
• Design and deliver technical training for batch manufacturing and in-process sampling.
• Adheres to company policies, cGMP regulations, industry standards, SOPs/WIs, and supervisory directives.
• Supports safe and compliant pharmaceutical manufacturing processes.
• Performs additional responsibilities as assigned to support team and project objectives.

Required Skills & Abilities:

• 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.
• Proficiency in basic mathematics.
• Communicates clearly and effectively, both verbally and in writing.
• Basic computer skills (Word, Excel, documentation systems).
• Works effectively in a team environment.
• Accepts and seeks feedback and guidance to build technical and communication skill.
• Manages time and workload effectively to meet deadlines.

Education & Experience:

• 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.

Physical Requirements:

• 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.

To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily. PAI is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, PAI will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer. PAI uses E-Verify.

PAI Pharma is a nicotine-free campus, meaning the use of nicotine products—including cigarettes, vaping, chewing tobacco, and any other nicotine-containing substances—is strictly prohibited on company property. All employees should be able to complete their full shift without the need to use nicotine. By joining PAI Pharma, you agree to adhere to our nicotine-free workplace policy, which supports a healthier environment for all employees.

EEO Employer / Veteran / Disabled