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Process Specialist, NPI in Biopharma

Contract Type: Permanent
Location: Europe
Contact Name: Larry O’Leary
Contact Email: larry@rftgroup.ie

Job Description

Process Specialist, NPI in Biopharma
Our client, a drug development company in biologics, now seeks a Process Specialist to provide technical support on manufacturing processes relating to manufacture and oversight for a portfolio of externally manufactured products, ensuring drug development is on track and executed to client companies requirements to meet NDA filing.

The successful candidate will provide hands-on process management experience of all aspects of scale-up to commercial manufacturing, including oversight of development processes, validation, execution and documentation.

Note: this project will require the incumbent to work in Germany for 6 month period and then work in Dublin for a further 6 months, with some intermittent travel to Europe.

Responsibilities of Process Specialist:
  • Managing technical transfers to contract manufacturing organizations. This includes Technical Transfers of products from Development, internal sites and from CMO to CMO.
  • Driving process capability analysis to assess process robustness. Identifying and executing process robustness improvement projects, where required.
  • Supporting CMO/vendor selection – preparation of technical information packages, participation in due diligence and site assessments, technical evaluation of RFIs and RFPs.
  • Providing technical guidance in the understanding of root causes for out of trend or out of specification results or deviations for manufacturing processes.
  • Driving the use of strategies, resources and processes (OPEX etc.) to improve processing efficiency and to ensure optimised technical support for manufacturing, technical transfer and scale-up of processes to commercial scale.
  • Provide technical support for change management, investigation CAPA identification and related activities at contractor.

Requirements for Process Specialist:
  • Bachelor’s Degree Process Engineering, Chemical Engineering or BSc in Chemistry or similar discipline. Ideally Masters or PhD qualification.
  • Experience as the technical lead on new product development, scale-up, technical transfer projects into commercial manufacturing cGMP.
  • Subject Matter Expert in process development, process management and trouble shooting, process robustness improvement through to commercial manufacture cGMP.
  • Demonstrated capability in the use of standard tools for root cause analysis.
  • Confident management of internal and external stakeholder relationships.
  • Strong communication and negotiation and influencing skills are required.
  • Experience in regulatory filings, e.g. NDA filing and associated documentation requirements to FDA regulations.
Please phone Larry on 01-2302400 / larry@rftgroup.ie

The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie