Glenmark Pharmaceuticals · 1 day ago
Research Officer
Monroe, NC
Full-time
Onsite
Mid Level
3+ years expGlenmark Pharmaceuticals is actively seeking a Research Officer to join their growing team in Monroe. This role involves providing technical support for scaling up and transferring manufacturing processes for new products, as well as ensuring successful commercialization at both internal and external sites.
BiotechnologyHealth CarePharmaceutical
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
Should be capable of drafting Batch Records and Protocols/Reports for new products
Should understand and interpret the DoE Reports, QbD reports for successful process scale up
Expected to guide Cross functional Teams on New Product’s process criticalities
Should be capable to dealt 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
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
Qualification
Required
Minimum-B.S. Pharmaceutical Sciences / B.S. Engineering
3+ years in Pharmaceutical Industry (FR&D/PDL/Tech. Services)
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
Scale up, Site Transfer and Commercialization of New Products (Injectable, Oral dosage forms)
Knowledge of regulatory guidelines in the pharmaceutical industry
Preferred
MS Pharmaceutical Sciences / MS Engineering
Company
Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company.
10001+ employees
H1B Sponsorship
Glenmark Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (4)
2023 (1)
2022 (4)
2021 (6)
Funding
Current Stage
Public CompanyTotal Funding
$58MKey Investors
HDFC Mutual FundTrue NorthActis
2025-06-19Post Ipo Equity
2018-08-13Post Ipo Equity
2002-07-01Private Equity· $48M
Leadership Team
Brendan O'Grady
Chief Executive Officer
Rajeev Sharma
Senior Vice President Finance & CFO - North America
Recent News
2025-12-24
Business Standard India
2025-12-17
Company data provided by crunchbase