Research Officer - Research and Development(Tech Transfer)

Glenmark Pharmaceuticals - Monroe, NC

Full-time - Mid Level

Monroe, NC

Chemical Manufacturing

About the position

The Research Officer in the Tech Transfer team at Glenmark Pharmaceuticals is responsible for providing technical support for the scale-up and site transfer of manufacturing processes, as well as the commercialization of new products. This role involves performing project activities related to new product introductions at the Monroe site and external manufacturing sites, including managing scale-up batches, exhibit/registration batches, and process validation batches.

Responsibilities

• Assist in performing project activities for new product introductions and site transfer projects into the Monroe site and external manufacturing sites.
• Conduct scale-up batches, exhibit/registration batches, and process/cleaning validations.
• Understand pilot studies, scale-up, DOE, process optimization, technology transfer, and troubleshooting.
• Detect gaps in the manufacturing process and identify potential for process improvements/optimization.
• Work in teams to resolve technical issues in manufacturing and ensure adequate process capability and control for all products.
• Prepare protocols for scale-up and engineering batches for new products.
• Create gap analysis reports and risk assessment reports.
• Support manufacturing investigations relevant to OOS, OOT, and incidents, including data evaluation and root cause analysis.
• Attend technical training concerning CQAs, CMAs, and CPPs, and improvements in manufacturing processes and controls.

Requirements

• Bachelor's degree in Pharmaceutical Sciences or Engineering (MS preferred).
• 3+ years of experience in the pharmaceutical industry, particularly in FRD/PDL/Tech Services.
• Excellent technical protocol/report writing and review skills.
• Experience in pilot studies, scale-up, technology transfer, and troubleshooting.
• Knowledge of GMP guidelines in the pharmaceutical industry.
• Good communication and documentation skills in English, both written and oral.

Nice-to-haves

• Experience in process performance qualifications and continued process verification (CPV).
• Deep understanding of aseptic manufacturing and oral dosage forms unit operations.
• Flexibility in project management and execution.

Benefits

• Health insurance
• 401k retirement plan
• Paid holidays
• Professional development opportunities