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Principal Scientist, AP Clinical Supplies, Pharma Development


Source:
TIMESJOBS.COM
Location:
Mumbai, MH
Date:
16-11-2016
Job Code:
58297005
Categories:
  • Retail & Wholesale
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Job Details

Pharmaceutical Development & Manufacturing Sciences (PDMS) is part of the global Janssen Research & Development organization within Johnson & Johnson and is currently recruiting for an Asia Coordinator for External Supply Integration - Drug Product Clinical Supply Chain in China, India or South Korea.The PDMS Clinical Supply Chain holds the global responsibility all clinical supplies of Janssen Research & Development. Our activities include all in-house and outsourced planning, manufacturing and distribution of clinical supplies (API, Drug Product, Packaged Clinical Supplies), through a global network. We supply more than 60.000 patients in more than 300 clinical trials every year. The Principal Scientist External Clinical Supplies 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- Process Engineering expertise input to the Drug Substance & 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 [Responsibilities]Compliance responsibilitiesA 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 managementThis 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 CMOs Budget responsibilities- He/she has strong responsibility with respect to the dedicated operational and project budget. He will have full control of budget and cost during project realization in order to fulfill the financial restrictions.Personnel responsibilities- He/she will draw from a (global) project team with members out of different disciplines and with different functions that have their contribution to the project realization. The management of this team must lead to the required performances in order to realize the project objectives. - 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.- For small as well as for large projects, extensive contacts with different suppliers/contractors can be necessary in order to achieve the required project results. 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 [Requirements]Profile/skills- Knowledge in sterilization technology and parenteral processes including fill/finish is required, - - Knowledge in large molecule drug substance process development and manufacturing- Specific expertise Clinical Manufacturing, Process Engineering & Scale-up.- Elementary technical background (mechanics, electrical, PLC, )- Preferably Chemical, Mechanical or Pharmaceutical Process Engineering degree or equivalent with at least 10 years in pharmaceutical area.- GXP, Regulatory requirements, J&J / JPh-standards & guidelines, applicable Standard Operating Procedures, Engineering Technical Standards, Technical Safety Standards, Industrial Hygiene Standards, MS office applications - Excellent knowledge of English (spoken and written)- Willing to travel (up to 50%) Specific know how of systems- Elementary concepts of Facilities, HVAC and Utilities- Sterile liquid manufacturing, Fill Finish and lyophilization- 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)
Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 10-15

Requirements

Product Development | Production Management | Production/Manufacturing/Maintenance
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