QC Chemist -Level 3
- Experience Level
- Experienced (non-manager)
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 firstname.lastname@example.org
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671