Commercial Attribute Science Associate

1 month ago

Dublin, Ireland PSC Biotech Ltd Full time

About PSC Biotech

 

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 points 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.

 


Job Title: CW senior Associate Scientist

 

·        This job specification outlines the general responsibilities associated with the role of Associate Scientist within the Attribute Science Dept. of Process Development at client site. This role will be responsible for undertaking activities pertaining to Chromatography Analytical Method Troubleshooting, Analytical Method Lifecycle and Analytical support for process development activities at the site.

·        The successful candidate will have proven Chromatography experience acquired in the Pharmaceutical Industry, have a right first-time mindset, be a team player, have a strong understanding of customer service and work with QC colleagues to effectively troubleshoot analytical issues.

·        The successful candidate will also have a strong understanding of Data Integrity principles and compliance in the laboratory as well as good presentation/influencing skills (Influencing with Data/ Data storytelling). Proven experience with the use of statistical packages to aid analytical method troubleshooting would also be a distinct advantage.

·        Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with their role.



Requirements

Key Responsibilities:

·        Chromatographic method troubleshooting and development (HPLC/UPLC – CEX, SEC, RP, HIC, HILIC).

·        Use of Empower CDS at an advanced level (ability to create report methods, custom fields etc).

·        Experience with other analytical techniques would be an advantage (Capillary Electrophoresis, KF titration, compendial methods).

·        Timely documentation of Analytical data in the electronic notebook system.

·        Understanding of data flow in laboratory systems and data integrity.

·        Participate in the peer review of analytical data.

·        Responsible for providing technical guidance and applying expertise and critical thinking to help resolve technical issues with analytical methods in QC.

·        Qualification of analytical equipment and related testing functions.

·        Compliance with Standard Operating Procedures for the Attribute Sciences Laboratory.

·        Ensure the laboratory is operated in a safe and environmentally friendly manner.

·        Ensure ongoing compliance with phase appropriate GMP, including compliance within the LMS training system.

·        Ensure high levels of Laboratory housekeeping are maintained including inventory control of samples and consumables.

·        Ensure timely completion of Laboratory Investigations, Deviations, PMAFs

·        Participate in internal/external audits/inspections as required.

·        Plan and implement procedures and systems to maximise operating efficiency.

·        Manage and contribute to the achievements of department productivity and goals.

·        Engage with the Continuous Improvement Process and MyGreenLab® philosophy.

 

Qualifications:

·        Excellent written and verbal communication skills

·        Experience with Empower CDS at a poweruser/advanced user level.

·        Deep knowledge of chromatography hardware use and maintenance practices

·        Experience with Regulatory inspections and interaction with inspectors is preferable.

·        Experience working with teams and influencing decisions.

·        Skilled in the use of problem-solving tools/techniques

·        Experience with developing, validating, troubleshooting, bridging Chromatography methods.

·        Understanding of the Change Control and Variation Management Process

·        Understanding how the use of statistical tools, such as multivariate analysis can aid method troubleshooting.

 

Knowledge and Experience:

·        Hold a third level qualification (Degree) in Analytical Chemistry/ Biochemistry or related discipline.

·        Have ?5 years of experience in a pharmaceutical Laboratory running Chromatography methods (in a PD and/or QC laboratory)

·        Strong background in General Analytical Chemistry/ Compendial Techniques such as Appearance, Colour, Clarity, ph, Sub Visible Particle testing, Osmolality, KF Titration is preferred but not essential.

·        Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.



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