QC Bioassay Lead
|Job Title:||QC Bioassay Lead|
|Contact Name:||Larry O’Leary|
|Job Published:||8 months ago|
Our client, a Biotech development and manufacturing company with rich pipeline, will now hire a Lead QC Bioassay Microbiologist who will provide leadership in the start-up and development of a new Bioassay laboratory.
Acting as Designee for QC Manager, this hire will provide technical leadership of analytical method validations/ transfers for Biological Products as appropriate for GMP operations.
Additionally, this hire will work on more complex, non-routine projects and assignments; delivering new technologies and continuous improvement initiatives to meet business requirements
Lead Bioassay investigations/troubleshooting and technical projects within the function.
Proficiently execute Bioassay techniques such as ELISA, Receptor Binding, Flow Cytometry, and Cell-based assays
Develop subject matter expertise on assigned analytical techniques
Review data and results of testing to ensure compliance to appropriate specifications and protocols
Demonstrate skills in data analysis and ability to critically evaluate data quality
Provision of technical support to Operations for investigations and optimisation projects
Write and execute protocols and reports
Develop, revise, and implement procedures that comply with appropriate regulatory requirements
Execute analysis efficiently, consistently, and with high quality
Interfaces with key cross functional stakeholders locally and across the company network
BSc or a MSc in Biology, Biotechnology, or relevant scientific discipline.
5+ years of relevant experience, including prior industry experience in a Biologics testing laboratory is preferred.
Experience with analytical techniques such as Cell Culture, ELISA, Receptor Binding, Flow Cytometry, and Cell-based assays is required
Experience in method validation/ method transfers is required
Working knowledge of GMPs, GLPs, and regulatory requirements for Biologics testing
Advanced skills in proper aseptic techniques and behaviours
Knowledge of software such as Softmax Pro, LIMS and Trackwise
Excellent communication skills (both verbal and technical)- demonstrates the ability to clearly and concisely present/ explain tests, analysis, and outcomes to multiple audiences.
Excellent communication skills (both verbal and technical) – ability to present, explain tests, analysis, and outcomes to multiple audiences.
Excellent interpersonal skills and ability to work effectively with people in cross-functional environment.
Ability to work independently and as part of a team with internal and external partners.
Demonstrates the ability to handle more complex processes with limited support
For further details, please contact Larry on +353 (0) 1-2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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