Lab Analytical Specialist

About PSC Biotech Ltd

Who we are?

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:

An amazing opportunity has arisen for a Lab Analytical Specialist/Lab Analyst. You will join the Technical Engineering group on site and as part of the team you will be responsible for method validation and method transfers in the analytical development lab (ADL). This is an exciting opportunity to join a lab working on non-commercial activities. The role would be ideal for someone with experience working in within a QC / QO / Stability laboratory environment who is looking to move into a more project-based team.

Responsibilities:

The ADL is a non-commercial lab which has responsibility for all aspects of analytical support through development and clinical stages of new Drug Products on site. This involves method development and validation, testing of clinical materials and support to launch of the product. The Analytical specialist may also support improvement initiatives in any area of the analytical development business.

Support commercial analytical support for signification deviation in release and/or stability testing at Carlow site.

Support/lead the development and optimization of reliable, validated, analytical methods to characterize the quality attributes of drug substances and products for all projects supported by Carlow.

Provide the analytical CMC information for filings and responses to queries from worldwide regulatory agencies in connection with this information to support marketing approvals.

Lead the transfer of analytical methods, specifications and development knowledge for the drug substance and product. Establish relationships with key Supply and outsourcing partners that facilitate a clear understanding of analytical issues and product timelines. Continually executes the analytical elements of project to assure attention to critical issues and appropriate resourcing (by supporting functions) to meet project needs and timelines. In conjunction with the analogous areas in Supply establishes clear expectations regarding method transfer information content and logistics.

Comply with our companys Global and regulatory requirements and execute current Good manufacturing Practices (GMP) in the performance of day-to-day activities and all applicable job functions

Leadership activities including selection, development, coaching, and day to day management. Ensure that the team receives appropriate resources and programs to develop technical and other skills, to complete their jobs whilst stimulating personal growth and development in line with role. Develop and maintain training programs

Maintain outside contacts in the scientific community, universities, government and other outside laboratories in relation to analytical chemistry. Monitor industry trends, new technology initiatives and worldwide analytical regulatory guidance.

Work collaboratively to drive a safe and compliant culture in Carlow

This is a lab-based role so is primarily on site.

Requirements

Experience, Knowledge and Skills:

Knowledge of cGMP

Equipment and process validation

Knowledge of bioanalytical methods including, HPLC/UPLC, SEC, IEX, CE, ELISA etc.

Troubleshooting and maintaining process instrumentation and equipment.

Laboratory Quality Systems

Proficiency in Microsoft Office and job-related computer applications required

Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers

The ability to work in partnership with all plant departments in areas related to analytical development and validation

Self-motivated

Flexible approach

Excellent attention to detail

Demonstrable analytical and systematic problem-solving skills

Project management skills

Qualifications:

BSc. Qualification with minimum of 3 years experience as lab analyst or similar role in biopharmaceutical industry, ideally in a GMP setting

OR MSc/PhD Qualification with minimum of 2 years experience in analytical biochemistry or associated disciplines, ideally in GMP setting with experience as a senior scientist/analyst.