My Client, a global pharmaceutical company based in Co. Cork, is currently recruiting for a Senior QC Manager to join their team!
This QC Sr Manager role requires significant expertise/specialisation in Biological Product testing. You will be responsible for start-up and development of a Biologics potency laboratory, equipment purchase and qualification of lab equipment and will include Analytical Method Transfers, New Product Introductions, technical investigations and quality control testing to support our GMP operations.
Specific Job Responsibilities:
- Technical leadership of Analytical Method Validation/transfer for Biological Products as appropriate.
- Provision of technical support to Operations for investigations and optimisation projects.
- Deliver new technologies and continuous improvement initiatives to meet business requirements.
- Lead QC Micro 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 and ability to critically evaluate data quality.
- Proficiently executes biological laboratory techniques such 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.
- Onboarding and training of QC staff.
- Writes and revises methods, specifications, and SOP’s as needed.
Skills & Expertise:
- Experience in test methods for biologic and biopharmaceutical products
- Project management of laboratory set up
- 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
- Significant years of relevant experience with BA or BSc degree in Biopharmaceutical Science or equivalent.
- Prior experience in a Biologics testing laboratory a distinct advantage.
- Experience managing a team.
For a full Job Spec and to apply for this role please call Ciara 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