Research Officer

Position Summary

Glenmark is seeking a Research Officer to join their team in Monroe. The Research Officer Tech Transfer team will support scaling up and transferring manufacturing processes and commercializing new products.

Responsibilities

• Prepare protocols and batch records for scale-up, engineering batches for new products.

• Create gap analysis reports, risk assessment reports, and support manufacturing investigations for OOS, OOT, and incidents.

• Support cleaning validation and equipment qualification for new products.

• Understand and optimize pilot studies, scale-up, design of experiments (DOE), process optimization, technology transfer, and troubleshooting.

• Detect gaps in the manufacturing process, identify potential for process improvements, and work in teams to resolve technical issues.

• Document process capabilities and controls for all products, including drafting batch records, protocols, and reports.

• Guide cross-functional teams on new product process criticalities and ensure timely delivery to the site.

• Support site transfer activities for oral dosage forms, injectables, and pre-filled syringes.

• Drive CFTs on new projects, conduct equipment trials, and prepare necessary documentation.

• Guide contract manufacturers and third-party testing labs during site transfer activities.

• Work closely with R&D, MSAT, QA, QC for smooth tech transfers of oral dosage forms, injectables, and pre-filled syringes.

Requirements

• Minimum B.S. in Pharmaceutical Sciences or B.S. in Engineering (preferred)

• Minimum M.S. in Pharmaceutical Sciences or M.S. in Engineering (preferred)

• 3+ years of experience in the pharmaceutical industry (R&D, PDL, Tech Services)

• Excellent technical protocol/report writing and review skills

• Technical coordination with R&D, MSAT, Production team for development/exhibit/process validation batches/new launches

• Experience with pilot studies, scale-up, DOE, process optimization, technology transfer, and troubleshooting

• Good communication and documentation skills (written and oral), presentation skills, project management, flexibility

• Deep understanding of aseptic manufacturing and unit operations for oral dosage forms, injectables, and pre-filled syringes

• Knowledge of regulatory guidelines in the pharmaceutical industry