Johnson & Johnson Careers

principle engineer /Principal Scientist

Shanghai, China
Clinical Supplies


Job Description

Requisition ID: 1805691305W

General Objective & Responsibility: 

The ESI Scientist /Manager is responsible for drug product supplies and assuring timely delivery of clinical trial material from the Asian PDMS CMO network. He/she will partner with other CSC/PDMS functions, JSC, JRP and QA to assure all logistical, quality & technical elements are in place for RFT delivery of clinical material from the Asia CMO network. He/she will identify and implement new technology platforms, support vendor selection/identification/management, assure equipment/facility readiness and partner with the value streams on PF2P, scale up and tech transfer.

Assignment covers:
• Co-ordinate Execution of Clinical batches as per plan across ESI network in Asia.
• Process Engineering expertise input to the Drug Product Development teams
• Due diligence assessments of CMO for clinical trial material manufacture, including equipment and facility assessments to confirm capability for formulation, fill finish and clinical packaging.
• Support optimizations and / or changes to existing equipment
• E2E responsibility for the manufacture of clinical trial material meeting the clinical demand schedule.
• Tech Transfer support includes commercial plant readiness for registration, launch and commercial production, DoE & Scale-up support

Specific Objectives & Responsibilities:

Compliance responsibilities:
A demonstrated ability and experience to work in a highly regulated environment (FDA/J&J standards and guidelines, general GMP guidelines) is required. Being informed about applicable internal and external rules (guidelines, laws…) with respect to requirements for equipment and relevant processes (literature, workshops, seminars…). 

Project management:
This information/knowledge must be applied in all projects where applicable, hence the following responsibilities:
• Process- and SHE-integrated approach (V-model, IQ, OQ, PQ, Cleaning Validation, Safety analysis…)
• Setup of the required cross-linked information platforms (QA, Manufacturing, Prevention, PDMS/JSC…)
• Review Master Service Agreement and define Scope of Work at CMO
• Define and follow-up on project, FTE and budget planning
• Follow-up on orders and invoicing according to project plan
• Periodic review and score card monitoring of CMO’s

Budget responsibilities:
The ESI senior Scientist will help to manage the operational budget as a devoted housekeeper. He/she has strong responsibility with respect to the dedicated operational and project budget.

Personnel responsibilities:
The ESI Scientist /Manager will co-ordinate with Internal and External stakeholders of different function to implement Clinical batch execution as per schedule.

External contacts:
Must be able to work with Contract Manufacturing Organizations to perform capability assessments and provide technical expertise to influence and bridge gap analysis to meet Clinical Trial Material requirements.
This means mutual exchange of information e.g. managing confidentiality agreements, applicable internal standards, user & process specifications, functional specifications and product information.
Benchmarking and updating internal knowledge means contact with and information exchanges with other pharmaceutical companies during workshops, seminars…

Internal contacts:
Main clients are Pharmaceutical Development and Manufacturing and Pack & Label within PDMS. In order to understand their needs, frequent contacts with production management, operators are extremely important for project definition and progress. Furthermore, intensive collaboration with Technical Integrators and Clinical Supply Integrator is required.
Contacts with all members of the project team of the different involved departments are common (i.e. Quality Assurance, Qual/Val, Engineering, SHE, Technical Operations, Technical Lead Integrator)
Frequent review meetings with DP Plant Owners and API supply for sourcing decisions and updates on projects.

Qualifications

Profile/skills
• Should be expert in Downstream manufacturing process in Large (Biopharmaceutical) molecule, with an in-depth knowledge of Equipment and Facility used.
• Specific expertise: scale-up/ technology transfer / Clinical Manufacturing/Process Engineering & in biopharmaceutical production,
• Elementary technical background (mechanics, electrical, PLC, …)
• Preferably Biopharmaceutical or Pharmaceutical degree or equivalent with at least 5 years in pharmaceutical area.
• GXP, Regulatory requirements including CFDA guidelines, Engineering Technical Standards for Biopharmaceuticals , Technical Safety Standards, Industrial Hygiene Standards, MS office applications …
• Excellent knowledge of English (spoken and written)
• Willing to travel (up to 40%)

Specific know how of systems
• Elementary concepts of Facilities, HVAC and Utilities
• IPC and monitoring systems.
• Basic concepts of CSV (computer system validation) systems.
• Equipment qualification, validation and change management systems.
• Specific tools such as ATS (analytical trouble shooting), PE (process excellence tools), Planning tools (MS-project), …
• Good documentation practices


Primary Location
China-Shanghai-Shanghai-
Organization
J&J (China) Investments Ltd (7046)
Job Function
Clinical Supplies
Requisition ID
1805691305W