Analytical Sciences Associate Specialist

PSC Biotech Corporation

Carlow

On-site

EUR 45,000 - 65,000

Full time

3 days ago

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Job summary

PSC Biotech is seeking an Analytical Sciences Associate Specialist to support the life cycle of analytical procedures, including transfers, validations and troubleshooting across QC, Manufacturing and Validation teams.

The role focuses on separations and biochemistry methods, data interpretation and regulatory compliance within a GMP environment at the Carlow site in Ireland.

Qualifications

Bachelor's Degree in Analytical Chemistry, Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, or a related scientific discipline.
2-5 years' experience within the pharmaceutical, biotechnology, or vaccine industry in a GMP-regulated lab.
Experience with analytical testing, data review, and technical documentation.
Experience with method validation, method transfer, compendial testing; chromatography, electrophoresis, ELISA or analytical troubleshooting is advantageous.

Responsibilities

Support/Lead analytical method transfers, validations, and compendial method verifications.
Perform laboratory-based analytical testing and technical studies using a variety of analytical techniques and instrumentation.
Generate, review, interpret, and verify analytical data and technical documentation.
Support lifecycle management and continuous improvement of analytical methods.
Assist with troubleshooting of analytical methods and laboratory equipment.
Participate in laboratory investigations, deviations, CAPAs, and change controls.
Collaborate with Quality Control, Manufacturing, Validation, Technical Operations, and Global Analytical teams.
Ensure compliance with cGMP, data integrity, safety, and regulatory requirements.

Skills

Analytical skills

Problem solving

Attention to detail

Communication & teamwork

Multitasking in fast-paced env

Education

Bachelor's Degree in Analytical Chemistry, Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, or related

Tools

HPLC/UHPLC

Empower Software

ELISA

Cell-based assays

Compendial testing

Data analysis

Root cause analysis

GMP documentation

Job description

Analytical Sciences Associate Specialist

Industry Pharma/Biotech/Clinical Research
Work Experience 4-5 years
City Carlow
State/Province Carlow
Country Ireland

Job Description

About PSC Biotech

PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.

Who are we?

PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.

Take your Career to a new Level

Employee Value Proposition

Employees are the "heartbeat" of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.

Overview

The Site Analytical Sciences AssociateSpecialist/Specialist role is responsible for supporting Analytical ProcedureLife Cycle through end-to-end method lifecycle management includingintroduction of new analytical methods, analytical transfers, SME assessmentfor all analytical method & equipment performance qualification,investigations, product testing and technical rationale. This work will supportpipeline and commercial products by utilizing expertise in the analytical areasof separations and biochemistry.

Requirements

Key Responsibilities

Support/Lead analytical method transfers, validations,and compendial method verifications.
Perform laboratory-based analytical testing and technicalstudies using a variety of analytical techniques and instrumentation.
Generate, review, interpret, and verify analytical dataand technical documentation.
Support lifecycle management and continuous improvementof analytical methods.
Assist with troubleshooting of analytical methods andlaboratory equipment.
Participate in laboratory investigations, deviations,CAPAs, and change controls.
Collaborate with Quality Control, Manufacturing,Validation, Technical Operations, and Global Analytical teams.
Ensure compliance with cGMP, data integrity, safety, andregulatory requirements.

Qualifications & Experience

Education

Bachelor's Degree in Analytical Chemistry, Chemistry,Biochemistry, Biotechnology, Pharmaceutical Sciences, or a related scientificdiscipline.

Experience

Minimum 2-5 years' experience within the pharmaceutical,biotechnology, or vaccine industry.
Experience working in a GMP-regulated laboratoryenvironment.
Experience with analytical testing, data review, andtechnical documentation.
Experience with method validation, method transfer,compendial testing, chromatography, electrophoresis, ELISA or analyticaltroubleshooting is advantageous.

Desired Technical Skills