北京招聘

Job Purpose

Provides to the Site the specialist knowledge, as Subject Matter Expert, of specific pharmaceutical processes or process technologies (e.g. Technical Steward for Galenics, for film coating, biologics – upstream or downstream, etc).
Oversees processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies.


Major Accountabilities

Knowledge management:
? Owns the knowledge of specific pharmaceutical manufacturing process technologies, locally, including any pilot scale, scale up or down, and Design of Experiments (DoE).
? Provides and assures the fundamental knowledge in the specific area of expertise through the provision of regular training and education programs for Process Experts and Operators.
? 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.

Subject Matter Expert SME for Technology platform:
? Deep Subject Matter Expertise for specific Technology Platform (e.g. film coating etc) or pharmaceutical processes (e.g. galenical, chemical, biologics – upstream or downstream, etc.) following process product/process transfer or handover from launch to commercial production.
? Designs and controls optimization projects relevant to his/her specific expertise.
? Provides SME expertise to perform process characterizion of the related pharmaceutical processes to increase robustness and sustainability.
? Supports Process Experts and Product Stewards in trouble shooting by providing second level of specialist expertise as Subject Matter Experts and by harmonising and optimising related technical processes across the units.

Single Point Of Contact (SPoC) for the technology
? Acts as the SPoC for the interface with global MS&T network and with technical development organization, for the corresponding global activities, to define and implement new technical standards for existing and new technologies and equipment (e.g., manufacturing equipment, Process Analytical Technologies PAT).
? Collaborate with technical development, other sites and global MS&T network to facilitate transfer of technical knowledge.
Responsible to perform technical feasibility trials related to process improvement and implementation of new manufacturing technologies.

Selection of process equipment
? Participate in the definition and selection of pharmaceutical equipment, through providing input to User Requirements (URS).

Audit support
? Maintain their work in inspection readiness level and provide the necessary support in any internal or external audit in addition to providing input to and review regulatory documentation.
? Participate in due diligence team, where applicable, for in-license projects.

Training
? Own the Training Curriculum for its Job Profile and provides the necessary training and support to new associates joining this position.
? Provide the necessary training and education on related technologies to Process Experts, Product Stewards and Operators.
? 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.

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