上海招聘

Job Title Galenical Champion (Formulation/Pharma Technology Champion)
Job Grade TBD
Department MS&T
Reports to (Job Title) MS&T Head

Job Purpose (State in one sentence the overall objective of the role)

Owns, develops and ensures robustness of galenical products within the site, and cross-sites when applicable, making sure that process understanding is embedded in the organisation through excellence in troubleshooting, product improvement programs and transfers/launches, as well as supporting the process experts on cross-functional investigations and training.

Major Accountabilities (Describe the 5-7 main results of the role to be achieved )

1. GLeads the galenical knowledge management of processes and products locally and cross-sites, including the pilot scale, scale up, and DoE experiments. Responsible to perform technical feasibility trials related to process improvement portfolio.
2. Subject Matter Expertise for Technology Platform following process product/process transfer or handover from launch to commercial production.
3. Acts as the Single Point of Contact (SPoC) for the interface with global MS&T network and with TRD for the corresponding global activities to define and implement new technical standards, including new technologies and equipment (e.g., manufacturing equipment, PAT).
4. Collaborate with TRD, ChemOps, other sites and global MS&T network to facilitate transfer of knowledge and participates in the impact assessment related to changes in DS variants, excipients and technology.
5. Assures the knowledge on actives and excipients, and its behaviour in the site's products are embedded in the process experts through the provision of regular galenical training programs.
6. Leads manufacturing process transfer activities between Novartis sites or from Novartis sites to Contract Manufacturing.
7. Provides first level (local MS&T) and second level (global MS&T) support to the PUs for process issues, harmonising and optimising key technical processes across PUs.
8. Identify most common problems on manufacturing components and technology, their causes and solutions in order to be handover it to PUs.
9. Lead and coordinate team for cross-functional root cause analysis and problem solving on technical quality issues, e.g., recurring deviations, OOS , quality-investigations, CAPA-studies, large, complex, significant process improvement projects.
10. Assures that the necessary benchmark is done internally in Novartis, and externally in the scientific and academic environment, in order to stimulate and to extend the knowledge, increasing the know-how of the associates and expanding it to the rest of the organization.
11. Participate in the definition and selection of pharmaceutical equipment, through URS definition.
12. To maintain their work in inspection readiness level and to provide the necessary support in any internal or external audit in addition to providing input to and review regulatory documentation.
13. To be a recognized scientific expert internally and externally by reporting and presenting scientific/technical work at internal/external meetings/conferences and publish in peer reviewed international scientific journals including patents.
14. Participate in due diligence team where applicable for in-license projects.
15. Owns the Training Curriculum for its Job Description and provides the necessary training and support to new associates joining this position.






Key Performance Indicators (Indicate how performance for this role will be measured)

1. Technical feasibility trials, scaling up performed according to plan.
2. Subject mater expert defined. Technology handover from launch to commercial on time and on quality Good process capability of assigned processes (CPK).
3. Effective liaison with the rest of the network, cross-sites and with TRD for timely resolution of product-related issues. Impact assessments/quality risk assessments performed on time and quality.
4. Training material is identified and training provided to Process experts according established plan.
5. Technical transfers executed according to global and local SOPs, on time and on quality.
6. Documentation and product know-how delivered to the Pus.
7. Decrease on recurrent deviation, increase CAPA effectiveness and investigation level.
8. Identify the appropriate SPOCs or SMEs outside of Novartis to support technical troubleshooting and improvements.
9. URS defined on time and Quality.
10. No critical or major observation in audits.
11. Training Curriculum up-to-date. New associates trained according to the T. Curriculum.

Dimensions of the JobJob Dimensions (Indicate key facts and figures)


Number of staff reportingassociates
? 0
Financial responsibility
(Budget, Cost, Sales, etc.)
? Contribute to PU financial/business goals
? Positive impact on write off decrease
Impact on the organisation ? High

Ideal Background (State the preferred education and experience level)

Education (minimum/desirable): ? BSc. In Science, Pharmacy or Chemical Engineering.
? Extended technical knowledge in area of own expertise
Languages ? Good knowledge of English proven
Relevant Experiences ? Minimum 7-10 years experiences in pharmaceutical formulation, process development, or manufacturing technology
? Strong Statistical background, IQP Silver certification (or green Belt equivalent) statistic level. Experience in DoE and Gage R&R would be preferable.
? Experience in the PAT technology for pharmaceutical products would be preferable.
? Fundamental understanding of standard pharmaceutical analytical testing.

Pharma operation - 北京诺华制药有限公司 北京昌平制药工厂诚聘