Senior Specialist, MSAT

Department: Validation

Location: Monroe, NC

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Position Summary:

Glenmark is actively seeking a Senior Specialist , MSAT to join the growing team in Monroe. The Sr. Specialist, MSAT will provide technical expertise to optimize commercial manufacturing processes and commercialize new products and technologies. This role is responsible for performing project activities for new product introductions into the Monroe site. This will include activities such as scale-up batches, equipment/systems qualifications, exhibit/registration batches, and process/cleaning validations. In addition, this role is involved in continuous improvements through data analysis, regulations updates and industry standards applicable to aseptic/ sterile drug products.

Responsibilities include but not limited to:

• 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

• In-depth understanding of equipment & facility qualifications, computer system validations, and cleaning validations

• 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

• In-depth understanding of equipment & facility qualifications, computer system validations, and cleaning validation

• Hands-on experience in Manufacturing Operation of Sterile /Parenteral formulations and related equipment (as applicable for the site). (Vial washer, tunnel, filling, capper, Lyophilizer, PFS, Manufacturing and filtration vessel, labelling , Inspection. Utilities : Water for Injection Generation and distribution, Purified water Generation , Compressed air, Pure steam & Nitrogen)

• Excellent technical protocol/report writing and review skills

• Design protocols for scale-up and optimization, exhibit, pre-validation, process performance qualification, hold time studies, and investigational studies based on a risk-based approach.

• Create gap analysis reports, risk assessment reports, and other product- and CAPA-related reports

• Assess change controls to evaluate impact to validation/qualification for equipment and process changes

• 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

• Responding to internal and external audit observations concerning manufacturing, process & validation-related deficiencies

• Attend technical training concerning CQAs, CMAs, and CPPs, improvement in mfg. Process and process controls

• Perform essential statistical evaluations (Running Chart, Box plot, Regression analysis, Cpk, and Ppk) of data and science-based and logical interpretation of data. Experience in Minitab/JMP software

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

• Coordination with cross-functional teams and assistance in resolving problems encountered during batch production and investigation (as required), assessing timelines, and ensuring resolution per the timelines

• Validation Protocol and Report preparation

• Prepare validation Protocol and Report as per guidelines and regulatory requirements

• Qualification of Manufacturing Equipment/Systems/Instruments

Education:

• Minimum-B.S. Pharmaceutical Sciences / B.S. Engineering preferred MS Pharmaceutical Sciences / MS Engineering

Experience:

• 9+ years in Pharmaceutical Industry (FR&D/PDL/Tech. Services/MS&T).Pharmaceutical and FDA is preferred

Knowledge & Skills:

• Understanding of product development, pre-formulation studies, and lab-scale batches.

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

• Experience in process performance qualifications, continued process verification (CPV), and continuous process improvement

• Expertise in equipment, facility qualifications, and computer system validations (CSV)

• Expertise in data analytics and data interpretation

• Experience in Technical Investigation and Root Cause Analysis

• Excellent technical report writing and review skills

• Knowledge of regulatory intelligence and guidelines in the pharmaceutical industry

  Other skills:

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

• Deep understanding of Aseptic Manufacturing

EOE/M/F/Vet/Disabled

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