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Site Manufacturing Science & Technology Head


Source:
TIMESJOBS.COM
Location:
Navi Mumbai, MH
Date:
12-11-2016
Job Code:
58262005
Categories:
  • Biotechnology & Science
Applying for this job will take you to an external site
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Job Details

Accountable to ensure that departments execute and maintain the VMP activities in their respective scope of responsibility, including, annual revalidation process and cleaning procedures. Ensure robust product stewardship for the all products manufactured at the site, and end-to-end technical oversight of product manufacturing processes, at all stages of their commercial lifecycle.- Ensure single point of contact for products within the site and across sites for multi-site products, as far as process technical issues are concerned.- Safeguard, maintain and develop the scientific information of product processes. - Ensure the robustness of manufacturing and packaging processes, so that all site products arevalidated and remain in constant state of validation throughout the product lifecycle. - Oversee and ensure the robustness and capability of manufacturing and packaging processes bymonitoring of each product s Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs)thru a continued process verification program and review of Annual Product Reviews (APRs)/Product Quality Reviews (PQRs).- Work with technical research and development organization to ensure a robust commercial scale-up of new products.- Lead technical transfer activities into the site. - Works across Process Units and Functions within the Site and in close collaboration with MS&Tglobal team to resolve issues and to ensure process capability. - Ownership and leadership of the site Validation Master Plan and coordinates all related activities.- Ensure oversight of technical changes and lead end-to-end change control management related to technical issues, working cross-functionally as required.- Act as the interface for the site with the relevant Health Authorities for technical issues. - Review and releases regulatory proposals or information required for regulatory filings. Support excellence in manufacturing through standard setting and technical capability development and deployment.- Support and, were appropriate, lead optimization of pharmaceutical processes by applying sound scientific reasoning (first principles) and following integrated process and technology strategies,triggering post launch development, when needed. - Ownership and leadership of the Product Improvement Portfolio (PIP), when applicable, and ensurecross-functional contribution as necessary. - Process standards management (e.g. write SOPs and manufacturing instructions).- Support capability improvements by deploying the specialist scientific and technical competence (e.g. quality, yield).- Equipment capability improvement (e.g. improve material flow). - Ensure the site has set and rigorously applies appropriate technical standards for processing,packaging and materials, where applicable, employing new/modern processes and technologies (e.g. Quality by Design (QbD), Design of Experiment (DOE) and Process Analytical Technologies (PAT)) Achieve the highest standards in identifying and addressing process issues. - Lead cross-functional root cause analysis and problem solving on technical process issues (e.g.,recurring deviations, quality-investigations, CAPA-studies). - Oversee remediation activities (e.g., revalidation). Support the identification and implementation of new technologies. - Identify and support the introduction of new technologies and equipment (e.g., manufacturingequipment) - Develop new equipment requirements (e.g., standard performance targets). Ensure development and deployment of highly specialist technical skills and knowledge to meet the needs of the sites product portfolio and strategy. - Foster knowledge transfer among Process Units within Site.- Design and support delivery of technical training (e.g., define training curriculum technical content), and to maximize opportunities to leverage shared training on Site/Region/Business Unit base.- Lead active knowledge management (e.g., ensure that each topic has an owner and backup, actively participate to dedicated MS&T networks, when existing, and disseminate the knowledge at theSite).- Support technical career path development (e.g., define performance expectations). Drive a culture of quality and compliance across the MS&T and Site team. Works with the other Site MS&T teams and networks of the relevant Region or Business Unit, driving reapplication of standard work processes, reapplication of best practices specifically in validation,training, process changes and handling of discrepancy and investigation resolution. Ensure that quality and compliance improvement and savings opportunities are rapidly re-applied globally. Work collaboratively with functional management in technical research and development organization and technical operations to ensure that Maintenance of Business projects (ie quality/complianceimprovements and savings projects) are identified, prioritized and delivered with excellence. Manage the MS&T career path, succession planning, training program and career progression within the.
Degree: M.Sc. (Science) | ME/ M.Tech./ MS (Engg/ Sciences)

Additional Degree: BE/ B.Tech (Engineering) | B.Sc. (Science)

Experience: 10-15

Requirements

Design Engineering | Product Development | Production/Manufacturing/Maintenance | QA/QC
Applying for this job will take you to an external site

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