Jobs
View more job listings or post a job
Roivant Sciences Director, Translational Sciences and Immunology
Horizon Therapeutics Senior Clinical Pharmacologist
Applied Cells Research Associate
Applied Cells Application Scientist
Juvena Therapeutics Principal Data Scientist – Drug Discovery & Development
Juvena Therapeutics Senior Computational Biologist – Proteomics
Peak Bio Senior Research Associate/Scientist - Protein Production
Peak Bio Analytical/Bioanalytical Scientist
Peak Bio Research Associate - Molecular and Cell Biology
Peak Bio Cell/Tumor Biologist - Scientist
Peak Bio Director, Antibody Drug Conjugate CMC
Peak Bio Research Associate - Translation
Post a job


Position:
Scientist/Senior Scientist- Regulated Bioanalysis

Employer:
Genentech

Description:

Job link Click to apply. Thank you!

The Drug Metabolism and Pharmacokinetics (DMPK) department at Genentech is seeking a highly motivated Scientist to join the Bioanalytical (BA) group.  The DMPK-BA group is primarily responsible for overseeing regulated bioanalytical activities conducted at contract research laboratories (CROs), and ensuring overall compliance with GLP/GCP regulations to support the preclinical and clinical development of Genentech’s small molecule programs.

 

Responsibilities include, but are not limited to:

  • Technical monitoring during bioanalytical method development, validation, and sample analysis; overseeing method transfer between CROs.
  • Reviewing validation reports and experimental documentation; and archiving relevant study documents.
  • Conducting CRO evaluation and selection.
  • Reviewing CRO SOPs.
  • Determine additional bioanalytical requirements if needed, and perform regular site visits and inspection.
  • Internally, the individuals are responsible for developing highly sensitive and specific bioanalytical methods for quantitative analysis of new chemical entities, metabolites, and biomarkers in a variety of biological matrices, reproducing CRO-developed methods, and performing non-regulated quantitative bioanalysis.
  • The individuals serve as bioanalytical representatives on interdisciplinary project teams. In addition, the individuals may train junior staff to successfully perform all the above-mentioned responsibilities.

 



Qualifications/Experience:

Qualifications:

  • Doctoral degree in analytical chemistry, biochemistry, or equivalent with relevant industry experience of 0 to 8 years. Master degree or Bachelor degree with relevant industry experience of 5-15 years.
  • Demonstrated ability to work independently in a fast-paced environment, as well as in a team setting.
  • In-depth bioanalytical knowledge and extensive experience with modern analytical instrument platforms, particularly with LC-MS/MS.
  • Hands-on experience in developing and validating LC-MS bioanalytical methods using various techniques (SLE, LLE, SPE, and PP).
  • Strong ability to manage multiple studies simultaneously and be able to assist in troubleshooting when instrument or assay problems arise.
  • Good understanding of GLP/GCP regulations.
  • Possess excellent oral and written communication skills.
  • Prior working experience at or with CROs is preferred.


Location: South San Francisco

Contact: chen.liuxi@gene.com

Post Date: 8/18/2022 10:17:26 AM
┬ęPharmaceutical & BioScience Society, International; Last Modified: 10/7/2022; Admin Logon
Ads (in random order)
Submit a Text Ad
($250 for 2 months)

iPRECIO Programmable Pumps PK/PD models and the limitations of traditional dosing methods. Methods & benefits of implantable microinfusion pumps in both rats & mice.
Alturas Analytics, Inc. Expert GLP & non-GLP LC-MS/MS, GC-MS/MS bioanalytical & PK/TK analysis services of small & large molecules in any matrix. Discovery through phase IV.
iPRECIO Programmable Pumps Evaluate drug efficacy in animal models in a clinically relevant manner with a Programmable Refillable and implantable pump. 3Rs and group housed.
Submit a Text Ad