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PRINCIPAL SCIENTIST ( API TECHNOLOGY )
Company:RFT GROUP |
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Job Reference Number |
14572051 |
Client ID: |
RI/ |
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Posted On: |
Feb 22 2012 |
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Location: |
DUBLIN |
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Job Type: |
Permanent |
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Salary: |
ASSOCIATE DIRECTOR |
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Benefits: |
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Our client is a highly profitable fast growing multinational biologics manufacturer. This newly created Associate Director role will be a key member of the API Science and Technology function, based in Dublin. With staff located in both the UK and the USA the team provides technical solutions to support Global Supply Chain.
The Associate Pharmaceutical Director provides leadership to ensure timely and effective implementation of product lifecycle changes and process improvements/enhancements at Contract Manufacture Organisations (CMO’s) managed by Supply Chain.
Activities also include ensuring that technology transfer projects are efficiently and effectively implemented, to support goals of quality, cost and customer service, and to ensure compliance to all cGMP, industry regulations, company guidelines, SOP’s and policies pertinent to work performed.
Job Spec :
CMO Product Management : Responsibility for managing the technical support for products (API’s and Critical Raw Materials) at CMO ensuring alignment with Supply Chain objectives.
Internal Product/Process Management of Supply Chain : Provide adequate support to the Product Strategy Lead (PSL) to achieve product and process technology objectives based on overall product strategies by the Business Unit:
• Participating in a cross-functional team to provide technical expertise for all CMO product related matters
• Maintaining and communicating project status and general issues to key stakeholders
• Provide technical direction in matters relating to change control, quality and regulatory issues and communicate decisions to the organisation
• Interacting with PSL’s, Global Materials Management (GMM) and R&D with regard to the eventual manufacture of New Chemical Entities and requirements with regard to Quality, Compliance and Regulatory issues
New Product Introduction : Responsible for the management related to CMO Technology Transfer of processes and/or R&D projects to the designated supplier to ensure a high quality robust process and to assure that the transfer site is in a state of pre-approval readiness capable of passing inspections by the regulatory agencies:
• Interacting with internal key stakeholders such as PSL, GMM, HS&E, R&D etc with regard to API issues that may affect the manufacture of drug product and requirements with regard to cGMP and Regulatory issues
• Overseeing, supporting and facilitating technology transfer from R&D and/or CMO’s
Manufacturing Process Robustness & Optimisation : Responsible to ensure that an optimal CMO environment is implemented for Supply Chain:
• Ensuring Analytical Method, Formulation/Process Robustness, Full Process Characterisation etc for assigned products is addressed
• Working in conjunction with R&D, identifies optimal product technology platform, QbD and Process Analytical Technology (PAT) tools to assure a robust/reproducible manufacturing process in alignment with GPT objectives
• Optimising Business Process and Product Improvements at CMO to reach new levels of performance, through implementation of Operational Excellence tools and projects
Quality, Safety and Compliance : Support conformance with regulatory filings initiatives, global agency requirements and safety needs and provide guidance, where possible on global harmonisation. This also includes providing technical guidance and knowledge on validation requirements.
CMO Product Metrics :Responsible to ensure GPT Metrics designed to achieve product and business objectives are effectively managed relative to product cost and life cycle opportunities through technology improvements which are process robustness, yields etc.
Person Spec :
The ideal candidate is an experienced Chemist with previous hands on API manufacturing and laboratory process development experience, a pharmaceutical background and late stage process development with the ability to trouble shoot and resolve process challenges.
BSc / Advanced degree in Organic Chemistry, Chemical Engineering or equivalent scientific/technical discipline with related experience
Proven track record of commercial API process problem solving
Applies expert knowledge in chemical development, process optimisation, process validation and API manufacturing.
Strong knowledge of modern analytical methods.
Ability to evaluate potential API vendors from all aspects of process development, analytical development and manufacturing.
Strong communication skills and the ability to work cross functionally.
Solid technical knowledge
Ability to travel to CMO's in the US, India and Europe (25%)
Cv to gerry@rftgroup.ie 01 2302400 www.rftgroup.ie
