Job Description

POSITION SUMMARY

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.

OVERALL JOB RESPONSIBILITIES

Responsibilities

Results Expected/ Target

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:

1.Should be capable of drafting Batch Records and Protocols/Reports for new products.

2. Should understand and interpret the DoE Reports, QbD reports for successful process scale up.

3. Expected to guide Cross functional Teams on New Product’s process criticalities.

4. Should be capable to dealt with Warehouse and Project Manager on timely delivery to the site.

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

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

7. Should be self-Driven and self-planned to drive the CFTs on New Projects.

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

Should be able to draft the necessary documents

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

Should 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

Knowledge and Skills (Functional / Technical)

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

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