Analytical Sciences Associate Specialist

PSC Biotech® Corporation; Carlow; On-site; EUR 40,000 - 60,000; Full time

Job summary

PSC Biotech, a leading biotech consultancy, seeks a Site Analytical Sciences Associate Specialist/Specialist to support the end-to-end lifecycle of analytical methods, transfers, and investigations across global clients. You will collaborate with Quality Control, Manufacturing, Validation, and Global Analytical teams to ensure cGMP compliance, data integrity, and timely method qualification.

Ideal candidates have a Bachelor's in a relevant field and 2–5 years of GMP laboratory experience, with

Qualifications

• Bachelor's Degree in Analytical Chemistry or related scientific discipline.
• 2–5 years' experience in pharmaceutical/biotech GMP environment.
• Experience with analytical testing, data review, and technical documentation.

Responsibilities

• Support analytical method transfers, validations, and compendial verifications.
• Conduct laboratory-based testing and technical studies using various techniques.
• Generate and review analytical data and documentation; support lifecycle management of methods.

Skills

Analytical skills

Attention to detail

Teamwork

Communication

Education

Bachelor's Degree in Analytical Chemistry

2–5 years GMP lab experience

Tools

HPLC/UHPLC

CE-SDS

icIEF

Empower

ELISA

Cell-Based Assay

Job description

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

About PSC Biotech

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Overview:

The Site Analytical Sciences Associate Specialist/Specialist role is responsible for supporting Analytical Procedure Life Cycle through end-to-end method lifecycle management including introduction of new analytical methods, analytical transfers, SME assessment for all analytical method & equipment performance qualification, investigations, product testing and technical rationale. This work will support pipeline and commercial products by utilizing expertise in the analytical areas of separations and biochemistry.

Requirements

Key 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.
• Support equipment performance qualification activities (PQ).
• 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.
• Supporting digital method development.

Qualifications & Experience:

Education:

• Bachelor's Degree in Analytical Chemistry, Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, or a related scientific discipline.
• Experience:
• Minimum 2-5 years' experience within the pharmaceutical, biotechnology, or vaccine industry.
• Experience working in a GMP-regulated laboratory environment.
• 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.

Desired Technical Skills

• HPLC/UHPLC (Agilent/ Waters)
• CE-SDS (AB Sciex instruments)
• icIEF (Maurice, Biotechne)
• Empower Software Competency
• Solo VPE
• ELISA
• Cell Based Assay
• Compendial testing and Method Verifications
• Data analysis and technical report writing
• Laboratory investigations and root cause analysis
• GMP documentation and data integrity practices

What We Are Looking For

• Strong analytical and problem-solving skills.
• Excellent attention to detail and commitment to quality.
• Effective communication and teamwork skills.
• Ability to manage multiple priorities in a fast-paced environment.
• A proactive approach to learning, innovation, and continuous improvement.