Manufacturing Project Manager (Pharma)

0016V6044 Manufacturing Project Manager (Pharma)

Please contact Amanda Mazza, [email protected]

We are seeking a skilled Manufacturing Project Manager with hands-on experience in solid dosage form pharmaceutical manufacturing to join our team. The ideal candidate will have a strong technical background in process design, optimization, and troubleshooting for solid oral dosage forms, including granulation, spray drying, tablet compression, and coating operations. This role will support both day-to-day manufacturing activities and capital or process improvement projects to enhance product quality, process robustness, and operational efficiency.

RESPONSIBILITIES

Provide technical support for the manufacturing of solid dosage forms, ensuring processes operate safely, efficiently, and in compliance with cGMP regulations

Lead or support process improvement and scale-up projects for granulation, spray drying, compression, and coating operations

Conduct process investigations, identify root causes, and implement corrective/preventive actions to resolve manufacturing issues

Develop and optimize process parameters to achieve consistent product quality and yield

Prepare and review process documentation including batch records, SOPs, validation protocols/reports, and change control documents

Collaborate with cross-functional teams (R&D, Quality, Validation, Maintenance, and Production) to ensure successful technology transfer and process validation

Support equipment qualification and process validation activities for new or modified equipment/processes

Analyze production data, generate reports, and recommend process or equipment improvements to enhance performance and efficiency

Ensure compliance with all safety and regulatory requirements within the manufacturing environment

QUALIFICATIONS

Bachelor's degree (or higher) in Chemical Engineering, Pharmaceutical Sciences, Mechanical Engineering, or related field

Minimum 3 years of hands-on experience in solid dosage form manufacturing (pharmaceutical industry required)

Strong knowledge of granulation, spray drying, tablet compression, and tablet coating processes

Familiarity with cGMP, FDA, and EMA regulatory requirements

Excellent problem-solving, analytical, and communication skills

Proven ability to work independently and in cross-functional teams within a fast-paced manufacturing environment

Proficiency with process data analysis tools and process control systems preferred

Onsite requirement in Indianapolis, IN

PREFERRED QUALIFICATIONS

Experience with fluid bed granulation and/or spray drying systems

Direct involvement in tablet compression and film coating process development or troubleshooting

Exposure to process validation, technology transfer, and scale-up activities

LOCATION

On-site in Columbus, OH

EMPLOYMENT

Full-time