Glenmark is a leading player in the discovery of new molecules, both NCEs (new chemical entity) and NBEs (new biological entity), with multiple molecules in various stages of clinical development & pre- clinical development. The company has a significant presence in branded generics markets across emerging economies including India. Its subsidiary, Glenmark Lifesciences Limited markets APIs to regulated and semi-regulated countries.

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.

Responsibilities Include (Not Limited to):

• This role is responsible to assist in performing project activities for new product introductions and site transfer Projects into the Monroe site and External Manufacturing Sites.
• This will include activities of scale-up batches, exhibit/registration batches, and process/cleaning validations such as
• Understanding of pilot studies, scale-up, DOE, process optimization, technology transfer, troubleshooting
• Experienced in 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
• Understanding of pilot studies, scale-up, DOE, process optimization, technology transfer, troubleshooting
• Hands-on experience in Manufacturing Operation of Sterile /Parenteral formulations and related equipment (as applicable for the site)
• Hands-on experience in Manufacturing Operation of Oral dosage formulations and related equipment.
• Hands-on experience in Vial washer, tunnel, filling, capper, Lyophilizer, PFS, Manufacturing and filtration vessel, labelling, Visual Inspection and CCIT systems.
• Prepare protocols 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
• Attend technical training concerning CQAs, CMAs, and CPPs, improvement in Manufacturing Process and process controls.

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
• Experience of pilot studies, scale-up, technology transfer and troubleshooting
• Experience in process performance qualifications, continued process verification (CPV), and continuous process improvement.
• Experience in Technical Investigation and Root Cause Analysis
• Excellent technical report writing and review skills
• Knowledge of GMP guidelines in the pharmaceutical industry
• 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

Other Skills:

• Good communication and documentation skills (English, written and oral), Presentation skills, Project Management, Flexibility.
• Good understanding of Aseptic Manufacturing, Clean Room Practices.
• Good understanding of Oral Dosage Forms unit operations and manufacturing equipment.

Education:

• 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:

• Knowledge on Scale up, Site Transfer and Commercialization of New Products (Injectable, Oral dosage forms).
• Knowledge of regulatory guidelines in the pharmaceutical industry