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Job IDEmployerPositionDescriptionRequirementsLocationContactPost Date
Details>> BioMarin
Scientist II - Pharmacokinetics/Pharmacodynamics
The Scientist II/Senior Scientist will be responsible for the design, execution, interpretation and reporting of clinical pharmacology and clinical/nonclinical pharmacokinetic/pharmacodynamic (PK/PD) studies. This includes the assessment of PK/PD relationships of recombinant protein and small molecule drug candidates that are situated throughout all stages of development (Phase 0-IV). The individual will assess and recommend dose levels and regimens for molecules in Phase 0-IV clinical development (including new indications for existing therapeutics) by working in close partnership with medical directors, clinical scientists, biostatisticians, bioanalytical research scientists, pharmacologists and toxicologists, , formulation and process scientists, and project teams. This assessment will require modeling, simulations and predictions of PK and PD, and make recommendations on dose regimen for drug candidates in clinical development. Population PK/PD and exposure-response analysis of drug candidates will be conducted as the programs progresses in clinical development.. The individual will be responsible for the planning, implementation and organization of regulatory filings along with presentation of PK/PD data to internal cross-functional teams, external collaborators, US and ex-US regulatory authorities and the scientific community.
EXPERIENCE At least 2 years for Scientist II or 5 years for Sr. Scientist of industry experience. Required: Strong background in quantitative clinical pharmacology analysis, pharmacokinetics and/or statistics with extensive knowledge of drug development process Required: Extensive hands-on experience with population PK/PD and exposure-response analysis using NONMEM/R/SPLUS software in clinical drug development Required: Extensive hands-on experience with non-compartmental and compartmental PK/PD analysis using WinNonlin Required: Excellent writing and verbal communication skills both cross-functionally within BioMarin as well as outside to various regulatory agencies. Required: Hands-on experience with preparing clinical pharmacology/PK/PD related sections in regulatory submissions (i.e., IB, IND, NDA, MAA, BLA). Required: Extensive clinical pharmacology and clinical/nonclinical PK/PD study design, implementation and interpretation; experience in modeling and simulation Required: Experience with GLP procedures and documentation or equivalent familiarity with FDA guidance’s. Preferred: In vitro/in vivo ADME experience Preferred: Pharmacokinetic experience with biologics and the associated immunogenicity issues is a plus. EOE.
San Rafael, CA
7/22/2014 9:15:41 PM
Details>> Carter Mackay
Pharmacologist
I am seeking a PhD with 6+ years experience in pharmacology. Should have experience (highly preferably industry) in two areas specifically 1. In vivo (animal studies), experience in the development of oncology therapeutic antibodies and antibody conjugates (ADC's) 2. Experience in the development of humanized mouse models and their use in oncology drug discovery The person would also have knowledge of oncology and some immunology. Solid communication skills and knowledge in related molecular/cellular biology techniques is also preferred. please contact me for more info or to be considered for the role.
PhD and 6-12 years experience.
southern California
broseberry@cartermackay.com or call 720-328-9526
7/17/2014 8:10:13 AM
Details>> Tricida
Sr Scientist Analytical Development and QC (Sci-Analytical 004)
Tricida, Inc. is an innovative new startup company focused on the discovery and early clinical development of novel therapeutics to address renal, metabolic and cardiovascular disease. Tricida is led by a management team with an accomplished and proven track record in discovering and developing new therapeutics, with extensive experience in building successful companies around strong science and unmet medical needs. The company is backed by world-class venture capital firms. We are looking to build a group of exceptionally-talented and well-motivated scientists and physicians to participate in a new effort to bring novel cardiorenal medicines into clinical development. RESPONSIBILITIES • Develop, qualify and validate analytical methods • Perform analysis following established chromatographic methods • Evaluate and improve existing analytical tests and assays • Analyze data and troubleshoot method, hardware and software issues • Maintain laboratory equipment (log books, inventory of consumables) • Review/write analytical test methods, protocols and reports; interpret/present analytical data at team and leadership meetings • Coordinate analytical activities at selected CRO and CMO sites (method transfer, validation and testing)
• Hands-on experience in more than one of the following techniques is a must: IC, HPLC, UPLC, GC, GPC/SEC, • Proficient in one or more of the following detection techniques is a plus: Conductivity, RI, UV, PDA, ELSD, Charge Aerosol Detection, Mass Spectrometry • Good knowledge of solid state characterization (e.g. IR, NMR, XRD, XPS, DSC, TA and Light Scattering) is a plus • Experience with providing rapid turn-around analytical support in a start-up environment is required • Must be self-motivated, detail oriented, and flexible in handling project assignments • Ability to exercise independent judgment in developing methods and evaluation criteria needed to obtain results is desired • Excellent working knowledge of the ICH Guidelines regarding Quality and Stability Testing, GMPs and GLPs and other regulatory requirements is a plus • Excellent communication and interpersonal skills for a team-oriented environment is required, along with the ability to be flexible and collaborate on projects QUALIFICATIONS: • PhD degree in Analytical Chemistry or related disciplines with minimum 2 years relevant industry Experience Benefits offered by Tricida are highly competitive
South San Francisco, CA
jobs@tricida.com
7/13/2014 9:45:12 PM
Details>> Tricida
Research Associate Analytical Development and QC (RA-Analytical 003)
Tricida, Inc. is an innovative new startup company focused on the discovery and early clinical development of novel therapeutics to address renal, metabolic and cardiovascular disease. Tricida is led by a management team with an accomplished and proven track record in discovering and developing new therapeutics, with extensive experience in building successful companies around strong science and unmet medical needs. The company is backed by world-class venture capital firms. We are looking to build a group of exceptionally-talented and well-motivated scientists and physicians to participate in a new effort to bring novel cardiorenal medicines into clinical development. Tricida is currently recruiting Research Associate position, listed below: RESPONSIBILITIES • Perform analysis following established analytical methods • Evaluate and improve existing analytical tests and assays • Analyze, interpret and present analytical data at team meetings • Troubleshoot method, hardware and software issues as well as maintain laboratory equipment (log books, inventory of consumables) • Write analytical test methods, protocols and reports
• Good knowledge of chromatographic techniques is a must (IC, HPLC, GC) • Proficient in one or more of the following detection techniques is a plus: Conductivity, RI, UV, PDA, ELSD, Charge Aerosol Detection, Mass Spectrometry • Must be self-motivated, detail oriented, and flexible in handling project assignments • Must have working GMP knowledge • Must display strong communication, organizational and interpersonal skills for a team-oriented environment QUALIFICATIONS: BS or MS degree in Analytical Chemistry or related disciplines with 2 years relevant industry experience Benefits offered by Tricida are highly competitive
South San Francisco, CA
jobs@tricida.com
7/13/2014 9:43:32 PM
Details>> Novartis Institute of Biomedical Research
Investigator/Senior Investigator, Metabolism and Pharmacokinetics
The mission of the MAP (Metabolism and Pharmacokinetics) department at NIBR in Emeryville is to ensure that drug candidates have optimal absorption, metabolism, distribution and pharmacokinetic/pharmacodynamic properties before progression to development. We achieve this through novel approaches to bioanalysis, expertise in metabolism and pharmacokinetics, innovation, collaboration, and teamwork. Key responsibilities include: •Represent the department on cross functional drug discovery project teams and provide MAP input on candidate selection •Develop MAP screening strategies for discovery projects and manage all discovery MAP activities •Lead and conduct PK and PK/PD analyses with focus on infectious diseases •Perform PK modeling and simulation using software such as Gastro Plus and Phoenix to provide human PK and efficacious dose projection •Identify MAP issues and communicate effectively to the team, department head and senior management •Utilize scientific insight and knowledge to evaluate strategic decisions throughout the drug discovery process •Provide project strategy on key ADME, biotransformation, in vitro metabolism, in vivo pharmacokinetic and toxicokinetic data •Design in vivo MAP studies to evaluate the pharmacokinetics and pharmacodynamics of drug candidates. •Design and manage routine and mechanistic animal PK studies •Provide high quality MAP data to the Project Team in a timely manner, enabling program decision-making in the selection and advancement of drug candidates with optimal ADME properties from discovery into development
•PhD with at least 5 years of experience in drug metabolism and pharmacokinetics within a pharmaceutical or biotechnology company •Wide ranging experience working as a DMPK representative on drug discovery project teams •Solid understanding of all aspects of DMPK with emphasis on pharmacokinetics •Knowledge and experience with the design of experiments to define PK-PD relationships •Competency using non-compartmental and compartmental techniques as well as PK modeling software, e.g. Phoenix or equivalent •Comprehensive knowledge of DMPK screening assays, data interpretation, and their relation to the drug discovery process •Excellent understanding of in silico models and in vitro/in vivo correlations (IVIVC) •Proven scientific track record as supported by publications and presentations •Experience in Infectious Disease discovery project support is desirable •Strong problem solving and leadership skills and the ability to work in a highly interdisciplinary, team-based drug discovery environment •Strong interpersonal and communication skills The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Emeryville, CA
https://sjobs.brassring.com/TGWEbHost/jobdetails.aspx?partnerid=13617&siteid=5268&AReq=145108BR
7/1/2014 12:24:12 PM
Details>> Genentech, Inc.
Scientist (contract), DMPK
The DMPK group is dedicated to enabling the discovery, development and commercialization of safe and effective medicines by elucidating the absorption, distribution, metabolism, excretion and pharmacokinetic properties of small molecule drug candidates. We accomplish this through the application of state of the art technologies and sciences of bioanalysis, drug metabolism, drug transport and pharmacokinetics. The DMPK group works in close partnership with disciplines such as medicinal chemistry, pharmacology, toxicology, pharmaceutical sciences, clinical pharmacology and regulatory to optimize leads, select clinical candidates, conduct preclinical development studies, support clinical evaluation and contribute to IND and NDA filings. Job Description The responsibilities of a DMPK-BA Scientist contract position are to develop and routinely employ bioanalytical methods for the qualitative analysis of endogenous small molecules/peptides in CSF, plasma, and various biological tissues using mass spectrometry in support of biomarker discovery. Responsibilities will also include data processing, statistical analysis, and dissemination of results to project teams in support of drug discovery and development programs. The ideal candidate will have a proven ability to independently design and execute experiments by (nano/micro)LC-MS/MS and/or MALDI in support of biomarker discovery programs in a fast-paced environment. This role requires a good understanding of metabolomics and targeted/non-targeted bioanalytical techniques for the de novo analysis of endogenous analytes from complex biological samples. The candidate will work as a member of the bioanalytical group and will independently execute experiments involving sample preparation using automated liquid handlers, data acquisition on a state of the art high resolution FT-ICR MS and data processing/statistical analysis by supervised and non-supervised classification methods (e.g. PCA/ANOVA/multivariant analyses). The candidate should be able develop, validate, and troubleshoot methods/instrumentation. Other responsibilities will include electronic laboratory notebook keeping and communication of results to project teams.
Candidates for DMPK-BA Scientist/Associate Scientist contract position will have a Ph.D. in chemistry, biochemistry, or equivalent with relevant experience of 1-6 years. Experience with independent operation of FT-ICR MS, as well as, various nano/micro LC platforms and automated liquid handlers in support of metabolomics is preferred (similar experience in proteomics acceptable). Experience with bioinformatics and/or biostatistics is a plus. The candidate should possess excellent oral and written communication skills.
South San Francisco
sheerink@gene.com
6/26/2014 11:06:19 AM
Details>> Genentech, Inc.
Research Associate/Senior Research Associate, in the Analytical group of Small Molecule Discovery Chemistry
Please see our web site. http://www.gene.com/careers/detail/00432904/Research-Associate-Senior-Research-Associate-Discovery-Chemistry
http://www.gene.com/careers/detail/00432904/Research-Associate-Senior-Research-Associate-Discovery-Chemistry
South San Francisco
See web site
6/20/2014 8:35:27 AM
Details>> Genentech
Research Associate (Contractor), DMPK
LC-MS/MS Bioanalytical
BS in chemistry, biochemistry, or equivalent with a minimum of 1 year relevant experience
South San Francisco, CA
John Chen, yhchen@gene.com
6/4/2014 4:33:58 PM
Details>>  
6/4/2014 4:31:40 PM
Details>> BioSeek a division of DiscoveRx
Bioinformatics Engineer
We are seeking a motivated scientist with expertise in bioinformatics, statistical analysis, and data curation. In this position for the BioSeek division of DiscoveRx, you will be responsible for biological and chemical data curation, relational database build, and analysis software development that underpin the company’s BioMAP® cell-based phenotypic assay drug discovery platform. The successful candidate will work closely with research scientists and engineers for automation of the analysis workflow. Programming experiences with SQL databases, R, and a major programming language are required. Software development experiences in JAVA, C#, R, Matlab, and/or Spotfire are highly desirable. The successful candidate will feel comfortable working closely with end users who are biological scientists, enjoy autonomy in technical decision-making, and be self-motivated to learn new technologies and implement these using best practices. RESPONSIBILTIES AND DUTIES: • Develop Java applications with JDBC functions • Build SQL databases for software development and enterprise reporting • Perform statistical analysis in R and SQL • Curate biological and chemical data • Support all software and scientific data analysis needs for the company’s BioMAP® services business • Support and expand the company’s BioMAP reference database of drug activity profiles • Investigate and implement new software solutions, applications and data analysis pipeline • Collaborate with other members of the scientific staff to develop user requirements and prioritize • Other duties as assigned
• PhD or MScin Computer Sciences, Bioinformatics, Physics, EE, Chemistry, Biology, or equivalent experience • Development experience with Java, C#, Python, and/or Perl; ODBC/JDBC experience is required • Experience with RDMS, SQL query, and relational database normalization • Experience with statistical analysis in R • Knowledge of public bioinformatics, compound, and pathway databases like Drugbank, Entrez Gene, Gene Ontology, and Ingenuity Pathway • Familiarity with software in the biological sciences such as LIMS, Matlab, and/or Spotfire • Highly self-motivated, friendly, able to develop complex software independently • Enjoy working closely with scientists and end users
South San Francisco, CA
Email resumes to jobs@discoverx.com and reference job code DRx024-2014 EOE/AA/M/F/D/V
5/29/2014 1:29:44 PM
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