Research Officer

Research Officer

Glenmark is actively seeking a Research Officer to join the growing team in Monroe. The Research Officer Tech Transfer team will provide technical support to scale up/site transfer manufacturing processes and commercialize new products at Monroe and external manufacturing sites. This role is responsible for performing project activities for new product introductions at Monroe site and site transfer of the products to external manufacturing sites. This will include activities such as scale-up batches, exhibit/registration batches, and process validation batches.

Responsibilities:

Prepare protocols/Batch Records for scale-up, Engineering Batches for the new products.

Create gap analysis reports, risk assessment reports.

Support manufacturing investigations relevant to OOS, OOT, and incidents as required, including data evaluation, root cause analysis, identification, and establishment of the root cause using a data-driven and science-based approach.

Engineering and/or scale-up batches, exhibit/registration batches and Process Validation Batches support in Manufacturing area.

Cleaning validation and/or equipment Qualification support for the new products.

Understanding of pilot studies, scale-up, DOE, process optimization, technology transfer, troubleshooting.

Responsible for detecting gaps in the manufacturing process, potential for process improvements/optimization, and ability to work in teams to ensure resolution of technical issues in manufacturing and ensure adequate process capability and process control for all products.

Documentation:

Capable of drafting Batch Records and Protocols/Reports for new products.

Understand and interpret the DoE Reports, QbD reports for successful process scale up.

Guide Cross functional Teams on New Product's process criticalities.

Capable to deal with Warehouse and Project Manager on timely delivery to the site.

Work closely with R&D team, MSAT, QA, QC for smooth tech transfers of the oral dosage forms, Injectable and Pre-filled syringes.

Support Site Transfer activities for oral dosage forms, Injectables and PFS.

Self-driven and self-planned to drive the CFTs on New Projects.

Equipment Trials and necessary documentation readiness for Oral Dosage forms, Injectables.

Responsible for site transfer activities at external Manufacturing sites and Third-Party testing labs.

Guide CMOs and Third-Party Testing Labs.

Knowledge, Skills and Abilities:

Education (degree/diploma): Minimum-B.S. Pharmaceutical Sciences / B.S. Engineering preferred MS Pharmaceutical Sciences / MS Engineering.

Experience: 3+ years in Pharmaceutical Industry (FR&D/PDL/Tech. Services) is preferred.

Technical Skills:

Excellent technical protocol/report writing and review skills.

Technical coordination with R&D/MSAT/Production team for execution of Development/Exhibit/Process Validation batches/New Launches.

Prepare Batch Records, Protocols and Reports as per guidelines and regulatory requirements.

Pilot studies, scale-up, technology transfer and troubleshooting.

Process performance qualifications, continued process verification (CPV), and continuous process improvement.

Technical Investigation and Root Cause Analysis.

Excellent technical report writing and review skills.

Good communication and documentation skills (English, written and oral), Presentation skills, Project Management, Flexibility.

Deep understanding of Aseptic Manufacturing and Oral Dosage Forms unit operations.

Knowledge:

Scale up, Site Transfer and Commercialization of New Products (Injectable, Oral dosage forms).

Knowledge of regulatory guidelines in the pharmaceutical industry.