MS&T Site Head, ASPEX job in Fort Worth
|Employer:|| Novartis Pharmaceuticals|
|Job Type:||Full Time|
Leads the Site's MS&T organization, which is responsible to maintain and improve the scientific oversight of the manufacturing processes and technical changes, to maintain and improve the relevant body of technical knowledge and capabilities at the Site, and to ensure product stewardship across process units and functions at the Site.|
• Ensure robust product stewardship for all products manufactured at the Site and end-to-end technical oversight of product manufacturing processes at all stages of the commercial life cycle.
o Ensure single point of contact for process technical issues for products within the Site and across Sites for multi-Site products.
o Safeguard, maintain and develop the scientific information of product processes.
o Ensure the robustness of manufacturing and packaging processes, so that all Site products are validated and remain in constant state of validation throughout the product lifecycle.
o Oversee and ensure the robustness and capability of manufacturing and packaging processes by monitoring each product's Critical Material Attributes (CMAs), Critical Process Parameters (CPP), and Critical Quality Attributes (CQAs) through a Continued Process Verification (CPV) program.
o Work with technical Research & Development organization to ensure a robust commercial scale-up of new products.
o Lead technical transfer activities into the Site.
o Works across Process Units and Functions within the Site and in close collaboration with MS&T global team to resolve issues and to ensure process capability.
o Ownership and leadership of the Site Validation Master Plan.
o Provide technical review and discussion of Annual Product Reviews (APRs) & Product Quality Reviews (PQRs).
o Ensure oversight of technical changes and lead end-to-end change control management related to technical issues, working cross-functionally, as required.
o Act as the interface for the Site with the relevant Health Authorities for technical issues.
o Review and releases regulatory proposals or information required for regulatory filings.
• Support excellence in manufacturing through standard setting and technical capability development and deployment.
o Support and, where appropriate, lead optimization of pharmaceutical processes by applying sound scientific reasoning and following integrated process and technology strategies, triggering post launch development when needed.
o Process standards management (e.g. oversight of SOPs and manufacturing instructions).
o Ensure the Site has set and rigorously applies appropriate technical standards for processing, packaging and materials, where possible employing new/evolving processes and technologies (e.g. Quality by Design (QbD), Design of Experience (DoE), and Process Analytical Technologies (PAT)).
• Achieve the highest standards in identifying and addressing process issues.
o Ownership and leadership of product and process improvement, and ensure cross-functional contribution, as necessary.
o Lead cross-functional root cause analysis and problem solving on technical process is-sues (e.g. recurring deviations, quality investigations, CAPA studies)
o Support capability improvements (e.g. quality, yield) by deploying scientific and technical competence.
o Equipment capability improvement.
o Identify and support the introduction of new technologies and equipment.
o Oversee remediation activities involving revalidation.
• Ensure development and deployment of highly specialized technical skills and knowledge to meet the needs of the Site's product portfolio and strategy.
o Foster knowledge transfer among Process Units within Site.
o Design and support delivery of technical training (e.g. define training curriculum technical content), and maximize opportunities to leverage shared training on Site/Region/Business Unit base.
o Lead active knowledge management (e.g. ensure that each process topic has an owner and backup, actively participate to dedicated MS&T networks, when existing and disseminate the knowledge of the Site).
o Manage the MS&T career path, succession planning, training program and career progression within the Site and across Sites.
• Drive a culture of quality and compliance across the MS&T and Site team.
• Work collaboratively with functional management in Manufacturing Technical Operations, Research & Development, and Quality Assurance to ensure that projects (quality/compliance improvement, savings projects, and business continuity) are identified, prioritized and delivered with excellence.
• Work with the other Site MS&T teams and networks of the relevant Region or Business Unit, driving best practices in validation, process changes, and new products and technology. Ensure that quality and compliance improvement and cost savings opportunities are rapidly reapplied globally.Bachelor's Degree (Science, Engineering, Pharmaceutical Technology) or equivalent years of directly related experience
The ability to fluently read, write, understand and communicate in English
10 Years of Relevant Experience
6 Years of Demonstrated Leadership