Principal Scientist(MSAT)首席科学家-常州/苏州/上海 Full-time

MSAT Principal Scientist

DIVISION: IMSC

DEPT NAME: Manufacturing Science and Technology (MSAT)

POSITION SUMMARY:

The MSAT Principal Scientist provides support on the following:

• New Product Introduction (NPI) / Technology Transfer
• Life Cycle Management (LCM) and base business support
• Process Improvements
• Standardization and New Technology deployment

MSAT Principal Scientist is a member of the Virtual Management Team (VMT) providing/coordinating the technical support to the site.

The MSAT Principal Scientist is expected to demonstrate Credo-behavior, Think Differently, Do Better and to continuously focus on safety, quality, GMP and operational discipline.

The MSAT Principal Scientist is a key contributor responsible for the planning, management and/or execution of the focus areas identified as above.

GENERAL RESPONSIBILITIES:

• Life Cycle Management
• Site selection, onboarding, and engagement
• Technical inputs into business case, support site selection with technical assessment, due diligence, fit for purpose and technical metric evaluation
• Qualification, on-boarding and process fit to plant assessment
• Engage CMOs with MSAT product/technical roadmap and external innovation deployment as necessary
• Pre-Tech Transfer readiness
• Support TLI, DPDS, MAM, EMST as required in pre-tech transfer activities and readiness for clinical manufacture and NPI primary transfers
• Manage pre-tech transfer activities and readiness in case of secondary transfers and post TOO transfers
• Tech Transfers
• Lead/manage secondary and LCM Tech transfers from external or internal site to external site
• Perform product introduction assessment and plan tech transfer strategy
• Lead characterization / DoE batches and PPQ batches documentation and execution
• Coordinate data evaluation and modelling with Stat or process science SMEs where necessary
• Complete technical assessment in CC and manage implementation with respect to technical parameters
• Product LCM
• Own / lead or participate in the CPV (continued process verification) program by issuing plans, strategies, protocols, and reports (usually authored by CMOs) and/or oversee the implementation and/or execution.
• Lead/support criticality analysis report authoring/reviewing
• Review APR/APQR for correctness and completeness of technical assessment and statistical evaluations
• Lead cleaning validation and support cross contamination assessment at the site
• Manage shipment qualification requirements and execution as necessary in coordination with Packaging CoE
• Provides process / technology input to SOP's, Master Batch Records and change controls for key initiatives.
• Partner with MAM, EHS, EQ and relevant SMEs as required and contribute to equipment changes / introduction / improvement projects on the site and Support sustainability initiative implementation at CMOs
• Perform process optimization/characterization as part of process improvement (scale up, equipment transfer, performance improvement)
• Site LCM
• Input and update account planning periodically
• Complete and update FFP segmentation from technical point of view (like tech risk matrix)
• Carry out proactive assessments like cleaning validation assessment (lead) and cross contamination assessment (support) etc…
• Base business support
• Lead, participate on complex process, product, or manufacturing systems investigations by providing technical expertise, and participate on key efficiency or reliability improvements including deviations, process failures, OOT/OOS, market complaints, CAPA and effectiveness check
• Manage material (RM/PM/Catalyst/key reagent) grade, site, source changes and qualification
• Ensure smooth / un-interrupted supply chain with on time technical support
• Technical support in partnership with Quality on regulatory audits and inspections in support of key initiatives
• Being the Spokesperson / SME in Audits and HA queries on technical matters
• New Product Introduction and Line Extensions
• Support activities related to clinical, NPI & line extensions such as tech transfers, scale ups and other key initiatives in support of TLI & DPDS
• Support planning and executing manufacturing in the site and / or oversee the execution at CMOs
• Review plans, standards, protocols and reports as necessary including CPV & criticality analysis reports
• Manage MSAT link to the external sites and VMT
• Manufacturing Process Excellence
• Proactive assessment – manage/support product and process capability assessment, product health scan and improvisation and de-risking projects
• Process improvements – manage/support cost improvement, cycle time improvement, yield improvement and manufacturability improvements
• Operational efficiency – manage/support capacity improvement, additional line qualification and equipment/system upgrades
• Technology upgrades – manage/support automation implementation, data acquisition & assessment and technology switch
• New Technology, Innovation & Standardization
• Scout, assess, benchmark / lead / contribute to new technology introduction including PAT technology, Process Modelling and Integrated data management systems as examples.
• Lead, contribute to Standardization initiatives for Technical Operations

KEY QUALIFICATIONS & SKILLS:

• COMPETENCY (knowledge, skills, abilities and experience required):
• 1. Specific knowledge
• Strong expertise on pharmaceutical manufacturing processes and equipment, specifically for the applicable technology platform
• General knowledge in the area of equipment qualification and process validation
• Project management (FPX or other) – team member of project lead depending on the role in the project
• Process excellence (6sigma), lean concepts and tools
• Strong knowledge of Quality & Compliance / regulatory requirements (GMP/EH&S) especially for Technology Platform.
• Statistical Skills
• Creation of proposals and business case
• 2. Personal and interpersonal skills / Leadership skills
• Ability to collaborate cross functional team – for those engineers / scientist leading projects in the site
• Ability to manage complexity and change
• Ability to interact at different levels of the organization
• Ability to work under pressure, handle conflicting interests
• Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly
• Ability to create a result oriented (project) team – for those engineers / scientist leading projects in the site
• Costumer and business focus
• Team player
• Problem solving skills and attitude
• 3. Personal attitude and mindset
• Drives for innovation and change to ensure competitiveness
• Can-do mentality, agility & flexibility able to work with stretched goals and deadlines
• Willing to place the goals of the team first and work with others towards these goals
• Communicative / Motivator / Negotiator having impact
• Showing a high sense of responsibility regarding professional activities
• 4. Good Manufacturing Practices (GxP)
• Adhere to applicable cGxP's and procedures (role model)
• Report incidents and deviations
• Propose solution to improve compliance with cGMP's
• 5. Safety, Health and Environment Performance
• Adhere to applicable EH&S and procedures (role model)
• Correct use of the available personal and collective protection materials
• Reporting of