Collins McNicholas

To perform this job successfully, an individual must satisfactorily perform each essential duty. 

 

Manages the R&D analytical group for activities assigned to Galway Product Development Department

Defines structure of group and supervises direct reports

Development of staff, to mentor each of them, and to look after their personal training needs, specifically, to provide training to extend their knowledge aligning with a more complex pipeline (e.g. Compliance, peptides, device testing, method development and validation…)

Sets clear goals and evaluates performance supporting business goals

Performs short and long-term resource planning

Setups Analytical capability/technology to support assigned products. Provide advice on troubleshooting equipment. Be a leading force to strive for technical excellence

Maintains analytical budget within agreed limits for regular finance reviews

 

Technical Leadership

Sets technical standards to comply with FDA/EMA or regional regulatory requirements

Maintains and monitor systems ensuring robust Analytical method development and validation

Supporting formulation and process development studies

Troubleshooting of problems associated with products within Registration stability

Sets specifications for a robust shelf life in accordance with ICH criteria

Troubleshooting of problems related to the transfer of methods to QC or other sites

Key decision maker in selection of new APIs and materials

Supports Analytical Team leaders to have more independent technical decision making

 

Operational Excellence

Control right first time (RFT) Quality Data generation, Operational Excellence and Lean Laboratory activities for projects assigned to the analytical staff in your team.

As a leader, actively seek to continuously improve the way we work in R&D Analytical.

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For a confidential discussion and more information on the role, please contact Edyta Fleming on 091706721 or email edyta.fleming@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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