Senior QC & NPI Scientist - Biotech

Berkley Group; Dublin; On-site; EUR 50,000 - 70,000; Full time

Job summary

Berkley Group in Dublin, Ireland seeks a Quality Control NPI Senior Associate to support QC, Process Development and manufacturing operations. The role involves analytical testing, data management, and contributing to audits and initiatives.

The candidate should have a science degree with 2–3 years of biopharmaceutical QC or GMP lab experience, and familiarity with GMP, Data Integrity and analytical tech like HPLC and rCE-SDS.

Qualifications

• Bachelor's degree in a science discipline.
• 2–3 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience.
• Demonstrated experience with current Good Manufacturing Practices, Data Integrity and analytical technologies (HPLC, rCE-SDS, Sub-Vis Particles, Protein Concentration/Protein Content).
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

Responsibilities

• Plan and perform analyses with great efficiency and accuracy.
• Plan and perform multiple, complex routine/non-routine methods and procedures and a large variety of assays.
• Report, evaluate, back-up/archive, trend and approve analytical data.
• Troubleshoot, solve problems and communicate with stakeholders.
• Initiate and/or implement changes in controlled documents.
• May train others as necessary
• Participate in audits, initiatives and projects that may be departmental or organizational in scope.
• May conduct lab investigations as necessary.
• Evaluate lab practices for compliance on a continuous basis.
• May represent the department/organization on various teams
• May interact with outside resources.
• Create APPX data files and randomisation memo to facilitate data analysis.

Skills

GMP compliance knowledge

Data integrity awareness

Analytical thinking

Education

Bachelor's degree in a science discipline

Tools

HPLC

rCE-SDS

Sub-Visible Particles

Protein concentration / protein content

cGMP testing

Job description

Berkley Group in Dublin, Ireland seeks a Quality Control NPI Senior Associate to support QC, Process Development and manufacturing operations. The role involves analytical testing, data management, and contributing to audits and initiatives.

The candidate should have a science degree with 2–3 years of biopharmaceutical QC or GMP lab experience, and familiarity with GMP, Data Integrity and analytical tech like HPLC and rCE-SDS.