Manager, Manufacturing Science and Technology (MSAT) - Monroe, NC

Department: Validation

Location: Monroe, NC

START YOUR APPLICATION (https://apply.hrmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req_id=3142637&source=3142637-CJB-0)

Provide technical direction and expertise to optimize commercial manufacturing processes, detecting gaps, process improvements and commercialize new products and technologies. Responsible for pilot studies, scale-up, DOE, process optimization, technology transfer, and troubleshooting. Design and review protocols for scale-up and optimization, exhibit, prevalidation, process performance qualification, hold time studies, and investigational studies based on a risk-based approach. Create and review gap analysis reports, risk assessment reports, and other product- and CAPA-related reports. Scale-up batches, equipment/systems qualifications, exhibit/registration batches, and process/cleaning validations. Continuous improvements through change control technical assessments, data analysis from continued process verification reports, regulations updates and industry standards applicable to aseptic/ sterile drug products. Change control of all essential process parameters, equipment, materials, and facilities to ensure impact analysis, accuracy, and compliance throughout the commercial life cycle. Lead/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. Project management of new product introductions into the Monroe site through direct reports and crossfunctional team members. Manages and reviews validation protocol and report preparation. Establish standards/templates for validation protocol and report as per guidelines and regulatory

requirements. Assisting in resolving problems encountered during batch production and investigation (as required), assessing timelines, and ensuring resolution per the timelines. This

position supervises MSAT Senior Specialist and MSAT Specialist (I, II, and/or III).

Qualifications and Requirements:

• Bachelor-s degree (or its U.S. Equivalent) in Pharmaceutical Sciences, Chemistry, or closely related fields.

• Applicant must have 12 years of experience in Pharmaceutical Industry, specifically in Formulation & Development, Process Development Laboratory, Technical Services and Manufacturing Science and Technology.

• Applicant must have: hands-on experience in Manufacturing Operation of Sterile/Parenteral formulations and related equipment; experience in leading technical functions with a proven track record; in-depth knowledge of product development, pre-formulation studies and lab-scales batches; and deep understanding of pilot studies, scale-up, DOE, process optimization, technology transfer & troubleshooting.

• Expertise in process performance qualifications, continued process verification (CPV), computer systems validations (CSV) and continuous process improvement.

• Expertise in data analytics, data interpretations, technical investigation and root cause analysis is required.

• Well-versed in regulatory intelligence and guidelines in the pharmaceutical industry is a must.

• Applicants must hold excellent communications and documentations skills (English, written and Oral), presentation skills, project management, emotional intelligence, strategic thinking, and flexibility.

• Domestic/International travel 10%.

40 hours per week: M-F. 9am-5pm. Must have proof of legal authority to work in the United States.

To be considered, please visit Glenmark Pharmaceuticals- career site website at https://glenmarkpharma-us.com/careers-at-glenmark/career-search/ to create a profile and submit a resume. Job# 20240107.

START YOUR APPLICATION (https://apply.hrmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req_id=3142637&source=3142637-CJB-0)