Scientist – Analytical

Desired Skills: analytical,method development,ELISA,HPLC

PE Global are currently recruiting for a Scientist, PDS&T analytical for our client site in Mayo on a 12 month initial contract:

Fully onsite

Scientist, PDS&T analytical

The primary goals of this position are to:

• Lead/support/execute the development, qualification, validation, and transfer of ELISA, HPLC, and other analytical methods to support New Product Introductions (NPIs). The Scientist II will ensure that methods are scientifically sound, compliant with regulatory standards, and efficiently integrated into production workflows to support clinical and commercial supply.
• Support lifecycle management of analytics for NPIs.
• Project management of analytics, generating and meeting timelines, working with various teams to keep projects on track.

Overseeing/supporting QC with co-ordination of release and stability testing, writing stability documents, data trending, supporting investigations, and leading and participating in cross-functional teams to support this work.

Responsibilities:

Method Development and Validation:

• Lead/support the development and validation of analytical methods (mainly HPLC and ELISA) for NPIs, ensuring methods meet all regulatory, client, and internal standards.  Applying QBD (quality by design) principles and ensuring methods are GMP compliant and QC ready. 

Technology Transfer:

• Support and oversee the transfer of analytical methods from R&D to the manufacturing site, ensuring seamless integration and minimal disruption to production.

Project Management:

• Plan, execute, and track projects related to method transfer and validation, ensuring timely delivery and meeting of project objectives.
• Compliance and Quality Assurance: Ensure all developed methods comply with Good Manufacturing Practices (GMP) and regulatory requirements, contributing to quality assurance processes.

Collaboration:

• Work closely with cross-functional teams, including R&D, quality control, manufacturing, and regulatory affairs, to facilitate innovation and address technical challenges.

Troubleshooting and Problem-Solving:

• Identify issues in method development and implementation, providing expert solutions to technical problems as they arise.

Documentation:

• Prepare and review technical documents, including protocols, reports, and SOPs, ensuring accuracy and compliance with regulatory standards.

Training and Mentoring:

• Train and mentor junior scientists and staff in method development and validation processes and best practices.  Training QC as part of handover of new methods.

Innovation:

• Stay abreast of industry trends and technological advancements, integrating new approaches and technologies into project activities as appropriate.

Reporting and Communication:

• Regularly report project status and findings to stakeholders, maintaining clear and open communication channels.

Requirements:

Education and experience:

• B.Sc in relevant science subject with at least 7 years experience or
• M.Sc in relevant science subject with at least 5 years experience or
• PhD in relevant science subject with at least 2 years experience
• Experience in analytical method development, transfer, and validation is preferred. 

Technical Skills:

• Proficiency in chromatographic (e.g., HPLC) techniques.
• Proficiency in bioassay (e.g., ELISA) techniques.
• Strong knowledge of GMP, ICH guidelines, and regulatory requirements for analytical methods.

Project Management:

• Ability to lead complex projects with cross-functional teams, applying effective project management methodologies.

Problem-Solving:

• Proven track record of resolving technical issues with innovative solutions.

Communication:

• Excellent verbal and written communication skills, with the ability to convey complex scientific data to diverse audiences.

Collaboration:

• Strong interpersonal skills and the ability to work effectively in a team-oriented environment.

Regulatory Knowledge:

• Understanding of the drug development process, including regulatory submissions (e.g., IND, NDA).

Innovation:

• Experience in implementing new technologies or methods within a regulated environment is a plus.

Interested candidates should submit an updated CV, marked for the attention of Audrey

audrey.mccarthy@peglobal.net  or  00353 21 4297900