Associate Manager MSAT | Pfizer | Visakhapatnam

Job Description

Roles and Responsibilities

• Provides support for site-to-site parenteral product transfers by interfacing with cross-functional departments across sites.
• Introduction of New Technologies to the site and qualification of the Technologies for intended usage.
• Prepare study protocols, Gap assessment, Risk assessment reports, recipe parameter recommendations, and CPP requirements in the developed recipe parameters.
• Plan and execute for Technology Transfer process including various activities like procurement of equipment for the developmental, Optimization, Scale-up, and Exhibit batches.
• Prepare and review necessary SOPs / URS/ study protocols / Qualification documents for Developmental/ Technology Transfer activities.
• Establish a Laboratory to perform the design of experiments, developmental batches, feasibility batches, lab scale batches as per plan.
• Technical support to the Manufacturing Team for the smooth launching of products.
• Prepare Study Protocols and Reports for process development and process optimization etc.
• Coordinate with external customers like Filter validation service providers, equipment manufacturers & Vendors, etc.
• Evaluate manufacturing Processes and Parameters/ CPPs for Scale and Exhibit batches manufacturing.
• Ensure compliance with cGMP/ cGLP, organizations’ procedures, and practices
• Ensure all the safety precautions are followed while at work
• Actively support the execution of Process Validation batches, Equipment Qualifications, and validations.
• Troubleshooting, and ongoing technical support to the Manufacturing team for Process validation, Continuous Process Verification, and Process improvement.
• Ensure compliance with cGMP/ cGLP, organizations’ procedures, and practices.
• Actively involve and drive Investigations related to Process engineering and Equipment to evolve CAPAs and monitor the effectiveness of CAPAs. Be able to apply the DMAIC tool to drive investigation studies.
• Performing day-to-day activities with Data Integrity Principles and Procedures.
• Contribute to the completion of projects, manage own time to meet agreed targets, and develop plans for activities on own projects.
• Lead process, product, and device improvements create data packages by justifying recommendations for improvements in production processes, and collaborate with technical staff to implement process technology initiatives.
• Installation and Qualification of Pilot plant equipment.
• Technical reports writing by generating necessary data / supporting data.
• Author protocols for process and cleaning validation, execute the validation studies in partnership with Operations Departments, and write validation reports.
• Provide technical leadership in investigations to determine root causes and implement appropriate corrective and preventive actions.
• Develop process flow diagrams for illustrating critical processes and material flow.
• Assist Technology Transfer, including Gap Analysis and Process Transfer Risk Assessments.
• Execute laboratory runs and writes technical reports summarizing laboratory results, generating necessary lab data to support product impact assessments during discrepancies and investigations.
• Partner with manufacturing to meet the production schedule, ensure commercial supply, uphold quality standards and driving towards zero defects.
• Evaluate new materials and primary packaging components.
• Analyze, apply, and interpret information and identify cause and effect relationships.
• Contribute to continuous improvement of current operations to improve Overall Equipment Effectiveness (OEE), quality and/or productivity using current methodologies.

Qualification: 

Must-Have

• Bachelor’s Degree
• 6 to 12 years of demonstrated experience in process engineering/ Technical operations/Technical services of parental process manufacturing in pharmaceutical / Sterile injectables.
• Proficient in terminally sterilized equipment train ie formulation process equipment, automation, washer, Tunnel, filling machines, Terminal sterilization, visual inspection machine, etc.
• Demonstrated technical capability and aptitude for technical learning
• Sound understanding of statistical experimental design and analysis
• Familiarity with the operation of cell culture and/or purification technology
• Ability to work on own initiative
• Excellent communication skills and fluency in English

Nice-to-Have

• Master’s degree
• Relevant pharmaceutical experience
• Yellow belt / Green belt certification
• Previous experience executing as a Technical Services Scientist {Product transfers, Process and Cleaning validation experience}
• Validation and analytics knowledge
• Basic knowledge of Delta V DCS.