Bioanalytical Development Manager
|Job Title:||Bioanalytical Development Manager|
|Contact Name:||Fareen Choudhry|
|Job Published:||January 19, 2017 10:54|
Bioanalytical Development Manager required for a leading a leading biopharmaceutical company. My client has a fantastic reputation and friendly team. They are a specialist biopharmaceutical company focused on the discovery and development of fully human monoclonal antibody drugs.
My client is looking for a Bioanalytical Development Manager take responsibility for the development, qualification and validation of pharmacokinetic, immunogenicity and soluble biomarker assays.
·To efficiently manage bioanalytical development activities for multiple projects, primarily through outsourced studies but also including some limited oversight of in-house laboratory activities
·To work within development project teams and take responsibility for defining and managing bioanalytical support for specific projects
·Defining study protocols, work plans, analytical methods and costs to fit project timeline and budget
·Review and finalisation of bioanalytical data, study documentation and reporting
·To keep up to date with relevant regulatory guidance and bioanalytical industry best-practice applicable to GLP, GCP and GCLP
·To assist with compilation and documentation of relevant bioanalytical documents to support successful IND or CTA filings
·BSc. or equivalent as a minimum, PhD an advantage
·Significant managerial experience in regulated (GLP & GCP) large molecule bioanalysis, including immunogenicity analysis
·Technical expertise in designing, optimising and trouble-shooting large molecule bioanalytical methods for pre-clinical and clinical drug development studies using platforms such as ELISA, MSD-ECL, DELFIA, AlphaLISA, Gyrolab
·Up to date knowledge of current industry bioanalytical standards and relevant regulatory PK, immunogenicity and biomarker guidance
·Working knowledge of FACS analysis an advantage.
Get in touch with Fareen Choudhry for more information: / 01737 236 737
GLP / Standard Operating Procedures / Molecular Biology / Leader / Management / Cell Culture / Biopharmaceutical / recombinant proteins / Regulatory / High-throughput / GCP / MSD-ECL / DELFIA / PhD / Cell Biology / AlphaLISA / Gyrolab / FACS / monoclonal antibody drugs / immunogenicity / CTA / IND / ELISA / bioanalytical
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