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**Job Function: **
Supply Chain Manufacturing
**Job Sub Function: **
Manufacturing Pharmaceutical Process Operations
Job Category:
People Leader
All Job Posting Locations:
Shanghai, China, Suzhou, Jiangsu, China
Job Description:
DIVISION: IMSC
DEPT NAME: Manufacturing Science and Technology (MSAT)
P****OSITION 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):
- 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
- 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
- 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
- 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
- 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 (near) accidents, incidents, deviations when on site
- Cooperate on and suggest solutions to improve EH&S
- Actively promote EH&S, support campaigns/programs such as “Safe behavior’
- Act when violation of EH&S rules is observed and stimulate appropriate behavior
LANGUAGES:
- Preferred: Fluent in written and spoken Local Language
- Required: Fluent in written and spoken English
**WORKING CONDITIONS: **
- Works in an international environment across different time zones
- Travel requirement: normally up to 50% and can further vary based on Projects and global Meetings
EDUCATIONAL QUALIFICATION:
- PhD, university degree or master’s degree in Chemistry, Chemical Engineering, Pharmacy or Biotechnology or equivalent through experience.
- Relevant experience in a pharmaceutical industry / environment.
- And/or an equivalent combination of education and experience: 1)Dosage Forms Engineering, Manufacturing and Primary Packaging 2) API Manufacturing and Purification for small/large molecules 3)Quality Assurance and Regulatory 4)Validations
**Required Skills: **
Preferred Skills:
Agile Manufacturing, Business Intelligence (BI), Change Management, Chemistry, Manufacturing, and Control (CMC), Cost-Benefit Analysis (CBA), Developing Others, Gap Analysis, Good Manufacturing Practices (GMP), Inclusive Leadership, Leadership, Manufacturing Standards, Operational Excellence, Organizational Knowledge, Plant Operations, Process Optimization, Regulatory Compliance, Resource Allocation, Team Management