Pharma Process Transfer & Scale-Up Lead

Aquestive Therapeutics; Portage (IN); On-site; USD 95,000 - 150,000; Full time

Benefits offered by this job

Bonus eligibility

Health care and other insurance

Retirement benefits

Paid holidays

Vacation

Sick days

Job summary

Aquestive Therapeutics in Portage, IN, is seeking a qualified engineer to lead product technology transfer and scale-up for thin film and dispensed LCO products. You will engage in cross-functional teams, drive process improvements, and ensure robust documentation and regulatory compliance.

This role requires a 4-year engineering degree with pharma process development experience, strong CGMP/CAPA knowledge, and the ability to work independently and with contractors.

Qualifications

• 4-year degree in Chemical engineering (preferred) or Mechanical engineering.
• 5–7 years of related pharmaceutical process development/manufacturing experience.
• Experience with coating, packaging, web handling and liquid dispensing in pharma.
• Strong documentation, CAPA and root-cause analysis skills.
• Proficient PC skills: Outlook, Word, Excel, PowerPoint and MS Teams.
• Knowledge of cGMPs, CAPA, risk assessment and investigations.
• Knowledge of project management, including capital funding requests and MS Project/Wrike.
• Excellent communication and teamwork abilities.

Responsibilities

• Lead new and continuous process improvement projects and manage MOCs.
• Support day-to-day manufacturing as SME; resolve process issues.
• Monitor processes, identify trends and drive continual improvements.
• Provide training support as required.
• Develop cleaning processes for equipment trains.
• Prepare documentation for new processes and MOCs, risk assessments, batch records, ES and SOPs.
• Prepare WOs, MOCs, DS, URS, SSD, FMEA for new systems/processes.
• Plan and lead product technology transfer and scale-up; determine parameters at pilot and commercial scale.
• Evaluate parameter variability on CQAs and establish manufacturing control strategy.
• Represent Engineering SME in Product Development Teams.
• Support deviation investigations and CAPAs.
• Coordinate with outside contractors for project support.
• Work independently and in multi-functional teams to ensure compliance.
• Interact with management, plant, organization and regulators; liaise with vendors.

Skills

Process transfer

Scale-up

Project management

CGMP

CAPA

Troubleshooting

Cross-functional collaboration

Data analysis

Documentation

Communication

Education

Chemical Engineering degree

Mechanical Engineering degree

Tools

MS Project

Wrike

MS Office (Outlook, Word, Excel, PowerPoint, MS Teams)

Job description

Aquestive Therapeutics in Portage, IN, is seeking a qualified engineer to lead product technology transfer and scale-up for thin film and dispensed LCO products. You will engage in cross-functional teams, drive process improvements, and ensure robust documentation and regulatory compliance.

This role requires a 4-year engineering degree with pharma process development experience, strong CGMP/CAPA knowledge, and the ability to work independently and with contractors.