Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Manager ESO MS&T
Position Purpose : Represents the main technical interface between Novartis and external suppliers by providing technical expertise on manufacturing and packaging process design, process- and cleaning-validation and resolution of technical issues. Applies an appropriate level of product and process oversight to ensure product quality and process robustness. Performs the technical due diligence in pre-evaluation phase to select the appropriate external suppliers together with BD&L. Acts as responsible Technical Transfer Lead to facilitate Product Transfers for legacy products as well as new development products from Novartis to external suppliers or between external suppliers. Aligns with the Development organization for manufacturing process design during early stage development Acts as the MS&T representative in assigned Supplier Relationship Team (SRT). Provides technical / scientific process support to respective Supply relationship teams (SRT) and works in close relation with other SRT members (QA Managers, Site Change Coordinators, Supply relationship Manager etc.) for evaluation of technical compliance activities (Deviations, Change controls, Customer Complaints, CAPAs). Ensures seamless flow of knowledge and information transfer within the organization and across functions with focus on process and product know-how.
Key Responsibilities :
1. Providing product stewardship by ensuring the performance of all NVS products are monitored and maintained in a validated state, supporting root cause investigations by providing MS&T intelligence to deviations, technical complaints, OOS & CAPAs, identifying and executing continuous improvement opportunities in Solid, Liquid, Sterile & Semi Solid Dosage forms.
2. Leading New Product Launch technical teams and leading technical activities of Drug Product Manufacture and Packaging depending on functional area of expertise. The Technical Manager is responsible for establishing a relationship with the MS&T organization of the CMOs and bringing MS&T topics on the agenda of the regular Business Review meetings.
3. The Technical Manager will be the technical SPOC for the assigned SRT representing.
ESO MS&T ADDITIONAL RESPONSIBILITIES
• Responsible for the successful transfer of the manufacturing process (Bulk DP and packaging) and its validation at the receiving site by ensuring subject matter risk assessment and excellence in execution and ensure all involved Documentation in place as per NVS requirements.
• Support site selection decisions at the ESO and/or global boards by providing analysis of technologies and manufacturing risk assessment.
• Establish the technical acceptance criteria and technical go/no-go decision points in collaboration with QA and Reg. CMC.
• Responsible for the successful transfers of manufacturing and packaging processes from Development into operations. He/she manages the ESO related technical launch and project improvement activities.
• Ensures appropriate project management to achieve milestones in time, with required quality and in budget.
1. BSc. in Pharmacy, Pharmaceutical Technology or equivalent scientific degree. • Desirable M Pharm. or PhD. Fluent in English.
2. 8 – 12 years of experience in pharmaceutical (chemical) manufacturing.
3. Experience in a global/matrix environment in the pharmaceutical industry
4. Comprehensive know how in pharmaceutical (chemical) technology.
5. Project Management experience, Drug Development experience, sound experience of data handling and applied statistics
Experience : 5+ years
Qualification : B.Sc, B.Pharm ; Desirable M Pharm. or PhD
Location : Hyderabad
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Technical Operations
ID : 291630BR
End Date : 5th April, 2020
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