Jobs
View more job listings or post a job
Simcere of America Inc. VP of Boston Innovation Center
Simcere Pharma Group 制剂研发总监或以上 Drug Formulation Director  
Simcere of America Inc. Job Title: Senior Director, Toxicology    
Simcere of America Inc. Associate Director/Director, Regulatory Affairs  
Simcere of America Inc. Director of Business Development
Simcere of America Inc. Job Title: Business Development Intern  
Charles River Laboratories Research Associate
Genomics Institute of the Novartis Research Foundation Senior Investigator (Associate Director) in DMPK
Pliant Therapeutics, Inc. Description: Pliant Therapeutics is an early stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic th
Genentech ASSOCIATE SCIENTIST, DRUG METABOLISM AND PHARMACOKINETICS - BIOANALYSIS (DMPK-BA)
Post a job


Position:
ASSOCIATE SCIENTIST, DRUG METABOLISM AND PHARMACOKINETICS - BIOANALYSIS (DMPK-BA)

Employer:
Genentech

Description:

The DMPK-BA function 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. The individuals in this function also conduct CRO evaluation and selection, review 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 inter-disciplinary project teams. In addition, the individuals may supervise and train junior staff to successfully perform all the above-mentioned responsibilities. 



Qualifications/Experience:

The ideal candidate for the DMPK-BA Associate Scientist position typically has a doctoral degree in analytical chemistry, biochemistry, or equivalent with relevant industry experience of 1 to 3 years. The candidate needs to possess a demonstrated ability to work independently in a fast-paced environment, as well as in a team setting. The candidate should have in-depth bioanalytical knowledge and extensive experience with modern analytical instrument platforms, particularly with LC-MS/MS. The candidate is expected to have hands-on experience in developing and validating LC-MS bioanalytical methods using various techniques (SLE, LLE, SPE, and PP), and have strong multi-tasking ability to manage multiple studies simultaneously and be able to assist in troubleshooting when instrument or assay problems arise. The candidate should have a good understanding of GLP/GCP regulations, and possess excellent oral and written communication skills. Prior working experience at or with CROs is preferred.



Location: South San Francisco

Contact: https://www.gene.com/careers/detail/201810-122923/Associate-Scientist-Drug-Metabolism-and-Pharmacokinetics-Bioanalysis-DMPK-BA

Post Date: 10/24/2018 10:06:47 AM
©Pharmaceutical & BioScience Society, International; Last Modified: 11/13/2018; Visited: 1306; Admin Logon
Ads (in random order)
Submit a Text Ad
($200 for 2 months)

Nuventra Pharma Sciences With a background in clinical pharmacology and PK/PD, Nuventra enables our clients to make better strategic decisions.
INTERTEK PHARMACEUTICAL SERVICES Intertek, a bioanalytical CRO (drugs, biologics, proteins, ADCs, biosimilar, generics, peptide, biomarker, immunogenicity, ADA, Nab) in San Diego CA
Avecia Pharma Services Nitto Avecia Pharma provides GMP contract development and parenteral manufacturing services to the pharma/biotech industries. Visit our Irvine labs!
Hypha Discovery Specialists in provision of drug metabolites at mg-g scale, including CYP/Non-CYP metabolites and conjugates such as glucuronides/sulfates.
Simulations Plus From sketching chemical structures, all the way through regulatory filings, Simulations Plus consulting experts can help. Over 20 years of experience!
Pharm-Olam International Pharm-Olam is a midsize CRO offering a wide range of Phase I-IV comprehensive, clinical research services to the pharma, biotech & device industries.
Simulations Plus From the developers of GastroPlus™ comes PKPlus™. NCA & compartmental PK modeling for regulatory submissions. True "PlugNPlay" PK.
Simulations Plus ADMET Predictor™ 9 - ADMET property estimation, HTPK Simulation, SAR elucidation, and QSAR model building software.
Solid Form Solutions Ltd Solid Form Solutions Ltd CRO providing Solid State Crystallization and Analytical Testing Services to the pharma/biotech industries.
S-Matrix Fusion QbD® Software – Analytical Method Development & Validation, Formulation & Process R&D. Works with ChemStation, Chromeleon, and Empower.
Sirius Analytical Services and Automated Instruments for pKa, log P/D, solubility, dissolution. New Scissor instrument for sub-cutaneous injection site simulation.
Origin Bioanalytical Laboratory A contract research organization for bioanalytical LC-MS/MS analysis specializing in ocular tissues/fluids located Rancho Cordova, CA
Pacific BioLabs Offers toxicology,microbiology,analytical and bioanalytical services with a combination of technical expertise & rigorous quality systems.
Nektar Therapeutics Sr. Scientist - Bioanalytical Contributes to the development, validation, and implementation of ligand-binding assays. PhD and 5 years exp.
Pharmaron Our Vision: To become the world-leading small-molecule life science R&D service company, supporting our partners from discovery to commercialization
BIOTECH WEEK BOSTON - Sept. 4-7 Join us at Biotech Week Boston - Where Big Science and Bright Minds Meet. Sept. 4-7, 2018 at Hynes Convention Center.
Charles River 2nd Annual Viral Summit The 2-day summit unites industry experts in an interactive setting to share updates and discuss trends in viral safety and viral clearance.
MicroConstants MicroConstants is a GLP-compliant Contract Research Organization focused on performing regulated bioanalysis, drug metabolism and PK analysis.
Reaction Biology Corporation (RBC) RBC provides kinase & epigenetic assays and proteins for early-stage programs. Contact: kelvin.lam@reactionbiology.com
Clinverse Inc. A global technology company solely focused on automating the financial management of clinical trials.
UC Davis UC Davis Liquid Chromatography/Mass Spectrometry and Confirmation Supervisor Apply Online: http://50.73.55.13/counter.php?id=139228 UC Davis i
Protein Characterization Seminar hosted by Charles River Join us in San Diego on September 15, 2017 to discuss the analytical methods used to detect process residuals and determine biosimilarity.
Zef Scientific California’s premier multi-vendor LC-MS/MS engineering firm with highest level of services & rapid onsite response on all major brands & models.
PHARMA INVENTOR Vancouver based Canadian Custom Synthesis Services Company, Offers Inventive & Cost-Effective Chemical Synthesis Services to Life Sciences Industries.
Simulations Plus GastroPlus™ PBPK modeling workshops scheduled around the globe to train scientists on the new guidance documents from the FDA and EMA. Register today!
Submit a Text Ad