Principal Scientist(MSAT)

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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 SOPs 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 cGxPs and procedures (role model)
• Report incidents and deviations
• Propose solution to improve compliance with cGMPs

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 masters 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: