QC Chemist -Level 3

My client, a global biopharmaceutical company in Co. Cork, are looking for a QC Chemist III to join their team!

This QC Chemist III role requires significant expertise/specialisation in analytics for Solid Oral Dosage and Biological Product Portfolios.  It is responsible for analytical operations including Analytical Method Transfers, New Product Introductions, process & cleaning optimisations, technical investigations and quality control testing to support our GMP operations.

Specific Job Responsibilities:

• Technical leadership of Analytical Method Validation/Transfers for Solid Oral Dosage & for Biological Products as appropriate.
• Execution of process and cleaning validation studies in support of New Product Introductions.
• Provision of technical support to Operations for investigations and optimisation projects.
• Deliver new technologies and continuous improvement initiatives to meet business requirements.
• Lead QC TS investigations/troubleshooting and technical projects within the function.
• Support the procurement and qualification of new equipment for new product technology transfers.
• Demonstrates skills in data analysis (ex: UPLC, HPLC, CE,) and ability to critically evaluate data quality.
• Proficiently executes biological laboratory techniques such as liquid chromatography, capillary electrophoresis (CE), and other separation techniques commonly used for biologics such as size-exclusion (SE) etc as well as Bio-Assays with experience in performing Cell Binding and Cell Cytotoxicity Assays
• Reviews data and results of testing to ensure compliance to appropriate specifications and protocols.
• Writes and executes protocols and reports.
• Assists in the training of QC staff.
• Writes and revises methods, specifications, and SOP’s as needed.
• May develop methods for performing cleaning validations.
• Demonstrates and applies an advanced level of understanding of project goals and methods

Skills & Expertise:

• Experience in test methods for Solid Oral Dosage, biologic and biopharmaceutical products
• Strong knowledge and understanding of cGMP, quality control (QC), and regulatory requirements for GMP laboratories in pharmaceutical industry.
• Advanced knowledge of current Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (GMPs).
• Hands-on experience with equipment qualification and analytical techniques such as UPLC/HPLC, CE, SE and potency assay is an advantage.
• Knowledge of software such as Empower and LIMS.

Typical Education & Experience:

• Candidate should have about 4-5 years experience with Masters, 6+ years degree experience biological techniques, chemical testing and bio assays.
• Prior experience in a biologics testing laboratory a distinct advantage.

For a full Job Spec and to apply for this role please call Zoe on +353 1 2784671 or e-mail zhamilton@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671