Senior Scientist, MSAT EM高级科学家，外部制造

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Changzhou, Jiangsu, China, Suzhou, Jiangsu, China

Job Description:

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 (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:

Coaching, Consistency, Controls Compliance, Critical Thinking, Data Savvy, Engineering, Financial Competence, Good Automated Manufacturing Practice (GAMP), ISO 9001, Lean Supply Chain Management, Leverages Information, Process Improvements, Quality Control Testing, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy