API Raw Material Technical Change Specialist | Collins McNicholas

API Raw Material Technical Change Specialist

  • Reference: CJ43702y
  • Job Type: Permanent
  • Location: Cork, Cork City, Munster
  • Category: Science, Pharmaceutical & Food

API Raw Material Technical Change Specialist 


Within the global supply chain for Consumer Healthcare there is a central technical support function supporting the five categories of Oral Healthcare, Skin Health, Pain Control, Respiratory and Nutritional with an aggregate sales value of £6 billion p/a in 145 countries.

The main responsibilities of the technical team are to identify and mitigate manufacturing and supply risk within the supply chain. This includes working with R&D and suppliers to understand and control manufacturing processes for new products, assess and mitigate technical risk within the existing product portfolio, managing cross functional technical projects that could affect the supply chain and providing expert level problem solving resource to support site based technical teams.

An opportunity has arisen within the CH Technical team to provide specialist technical leadership to API / raw material supplier changes for within the Consumer Healthcare Supply Chain. Whilst the major focus of this role will be on active pharmaceutical ingredients (API) the incumbent will also lead projects in highly critical excipients used in multiple products.

The candidate will perform the technical lead role for a number of complex raw material supplier changes, and support others in performance of same. They will lead the technical evaluation of changes, co-ordinate and complete all technical activities needed for implementation, and support the programme manager to plan and drive technical aspects of the supplier change to completion.

The incumbent will also ensure a standard methodology is established and rolled out throughout the technical community to allow site based and regionally based staff to develop this capability to support change projects.



Key Responsibilities:

  • Leadership of technical aspects of raw material supplier de-risking projects.`
  • Work with other functions to create detailed project plans and define project funding requirements.
  • Act as a technical expert to assess technical risk, define and manage validation activities, define product control strategies and carry out post implementation robustness reviews.
  • Consult with subject matter experts, where required.
  • Co-ordinate technical activities at third party labs, scale up facilities and at Supply Chain manufacturing sites to prove material equivalency, assess product stability and validate product changes.
  • Ensure all work is conducted in accordance with written procedures (quality and safety).
  • Generate or update GMP and change control documentation.
  • Identification of resource issues, elevation of risks/issues to management.



Basic qualifications:

  • Degree Level technical discipline in chemistry, process engineering, or related science related field.
  • Excellent understanding of chemical synthesis appreciation of the impact of source change on end use in intermediates or finished products.
  • Experienced process chemist process engineer with experience in working in a Pharmaceutical, OTC, or FMCG environment
  • Excellent communications (both written and verbal) in technical and professional English.
  • Able to demonstrate keen knowledge and a level of autonomy in the areas of formulation, analytical and process engineering.
  • Experience of working in cross-functional teams on complex technical changes.
  • Demonstrated experience of project leadership and ideally of change control programmes.
  • Ability to work with people at various levels in the organisation, internally and with external partners, providing technical analysis and fostering enthusiasm and teamwork.
  • Ability to work closely in corporation with teams at the manufacturing sites, R&D units and Contract Manufacturers and command co-operation of associates not under direct supervision


Preferred qualifications:

  • M. Sc. or Ph. D in relevant areas.
  • Demonstrated ability to effectively plan work and to manage projects with clear leadership and attention to detail.
  • Previous experience in raw material change implementation
  • QbD or lean, six sigma experience is an advantage.
  • Ability to use MS Project in planning programmes.
  • Understanding of technical risk assessment process and tools including FMEA, HAZOP, Material risk assessment processes etc.


For a confidential discussion and more information on the role, please contact Rory Walsh on 021 4911063 or email rory.walsh@collinsmcnicholas.ie

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie

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Rory Walsh

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  • Rory Walsh
  • Cork Regional Manager
  • 021 4809118
  • Connect with Rory
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