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Job IDEmployerPositionDescriptionRequirementsLocationContactPost Date
Details>> Dart NeuroScience
Research Associate/Associate Scientist, DMPK (Job Code: 14-019#0142)
An opportunity has arisen for an experienced Research Associate/Associate Scientist in the DMPK group. Primary responsibilities include developing bioanalytical LC/MS/MS methods for the quantitative analysis of small molecule drugs and their metabolites in biological matrices. Duties will also include PK analysis, data review, project tracking and report generation. The successful candidate will have good knowledge of the current state-of-the-art bioanalytical technologies. Experience with automation platforms is a plus. Candidate is expected to be able to work independently, to plan, execute and troubleshoot experiments. Candidate must have excellent organizational and communication skills.
Bachelors degree (or higher) in a biological science with a minimum of 4 years relevant experience • Experience in developing LC/MS/MS methods for the quantitation of drugs and their metabolites in biological matrix • Experience in working with liquid handlers • Demonstrated skills in bringing projects to completion within specified timelines • A good understanding of PK science and experience in applying DMPK concepts to drug discovery and drug development, and experience in PK analysis using WinNonlin is a plus • Motivated team player with a can-do attitude and good interpersonal skills • Good communication, organization and record keeping skills
San Diego, CA
Please submit resumes via this link - http://jobsco.re/1gwCqnz
4/14/2014 10:28:29 AM
Details>> Corcept Therapeutics
Director, CMC
Provide leadership and direction for Chemistry, Manufacturing and Controls (CMC) activities from pre-development through commercialization. • Determine requirements for specific CMC activities needed to support programs and translate these requirements into requests for proposals • Identify, evaluate and manage contract resources required to support drug substance synthesis, drug formulation, drug product manufacturing, analytical testing, packaging and labeling for all stages of development • Identify, evaluate and manage contract resources required for bioanalysis and ensure efficient integration between animal studies and bioanalysis. • Manage drug substance and drug product logistics to ensure sufficient materials are available to support planned nonclinical and clinical studies Provide formulation expertise and select the most appropriate formulation for pre-clinical and clinical studies. • Solve problems related to formulation, supply or other drug product or drug substance challenges • Provide expertise and scientific direction regarding the evaluation and selection of new product technologies, in association with cross-functional evaluations and requirements from research, clinical, commercial, and regulatory teams. • Innovate new formulations and drug delivery systems that provide clinical benefit and afford intellectual property. • Develop request for proposals describing detailed work and timeline requirements for submission to selected vendors; evaluate proposals and negotiate revisions; provide recommendation for vendor selection with clear rationale and justification for selection. • Develop regulatory and compliance strategies, with Regulatory and Quality Assurance, to ensure approval of regulatory submissions and compliance at contract vendors • Draft CMC sections of regulatory submissions • Keep relevant people, eg Director of Research, (others?) informed of progress and issues. • Other duties as assigned including travel
• Detailed knowledge of the drug development process • Detailed knowledge of ICH Q7 guidance, FDA and EU regulatory guidance for CMC • Detailed knowledge of manufacturing and analytical technologies required for manufacturing drug product and drug substance • Understanding of clinical and commercial packaging requirements and the ability to translate product dosing requirements into suitable product formulation and packaging design • Detailed knowledge of cGMP • Demonstrated leadership and influence skills • Excellent oral and written communication skills • Ability to handle multiple tasks with competing priorities • Self-direction in work habits • Excellent problem solving skills • Strong negotiation skills • Ability to utilize a wide range of computer applications and tools. • Ph.D. in Pharmaceutical Sciences or related field • 5-10 years minimum experience in a variety of drug product development programs
Menlo Park, CA
David Penake
4/3/2014 5:36:17 PM
Details>> MicroConstants
Principal Investigator-Manager, Bioanalytical Chemistry
MicroConstants, a Contract Research Organization (CRO) located in the Mira Mesa/Sorrento Valley area of San Diego, has an opening for a Manager in our Bioanalytical Chemistry Department. The incumbent will serve as Principal Investigator for GLP studies, a Study Director for validation projects, and manage a group of bioanalytical chemists, ensuring compliance with all laboratory Standard Operating Procedures (SOPs) and Good Laboratory Practices (GLP) regulations. Responsibilities will include, but are not limited to: *Serve as Principal Investigator/Study Director, ensuring compliance with USFDA, OECD and MHLW GLP regulations. *Write and review protocols and study plans for bioanalytical studies. *Communicate schedules and deadlines with internal team and study sponsors. *Discuss data and scientific issues in meetings and/or teleconferences with study sponsors. *Supervise the daily and weekly activities for Scientists reporting to the incumbent. *Review data packets, reports and methods for reporting Scientists. *Train new employees as they are hired into his/her group. *Assess daily analytical results generated by Scientists and assist them in troubleshooting problems quickly. *Participate in planning experiments and evaluating/interpreting test results utilizing detailed knowledge of research laboratory procedures and practices. *Work with other department Managers and Supervisors to maintain an appropriate schedule to meet deadlines and maximize the use of analytical instruments. *Assist in evaluating new technology and instrumentation.
*BA/BS in Chemistry, BioChemistry, Biology, or related science. *4+ years experience in bioanalysis using HPLC/MS/MS. *4+ years supervising groups of five or more in a lab environment. *Clear and concise understanding of drug discovery and development. *Knowledge of USFDA, OECD and MHLW GLP regulatory requirements. *Proficient with LC/MS/MS, HPLC, laboratory equipment and knowledge of relevant laboratory techniques. *Ability to communicate clearly in both written and oral forms and able to interface with all levels of management and clients. *Ability to organize, manage and operate a laboratory that conducts multiple studies simultaneously as well as participate in the negotiation of contracts. *Demonstrate proficiency with data management, analysis, and statistics, etc. *Ability to teach others technical procedures, maintenance, troubleshooting of scientific instrumentation and procedures. *Computer literate with knowledge of Microsoft Windows and Office, including Excel, PowerPoint, and Word programs.
San Diego, CA
jobs@microconstants.com
4/1/2014 3:14:33 PM
Details>> MicroConstants
Research Scientist, Method Development - Macromolecules/Biologics
MicroConstants, a Contract Research Organization (CRO) located in the Mira Mesa/Sorrento Valley area of San Diego, has an opening for a Research Scientist in our large molecule/biologics method development department. The incumbent will be responsible for exercising technical discretion in the design, execution and interpretation of experiments for research programs, as well as investigating, creating and developing new methods for project advancement. This work requires the use of scientific methods, procedures, and techniques gained through training and/or previous experience in accordance with USFDA Good Laboratory Practices (GLP) regulations and Standard Operating Procedures (SOPs). Responsibilities will include, but are not limited to: *Developing analytical methods using ELISA, LC/MS/MS or HPLC techniques to determine the concentrations of biological therapeutics including peptides, antibodies, ADCs, ATAs and neutralizing antibodies in complex matrices. *Independently exercising technical discretion in the design, execution and interpretation of experiments for research programs. *Investigating, creating and developing new methods for analytical method development and project advancement. *Maintaining a high level of professional expertise by researching scientific literature. *Understanding the regulatory requirements for validation of various methods and assay formats. *Training scientists to validate methods developed for the group. *Operating basic laboratory equipment with the capability of learning chromatographic instrumentation. *Maintaining and making minor adjustments to equipment, e.g. calibrating, alignment, and maintenance of accurate data records. *Preparing reagents for everyday use in the laboratory and storing appropriately. *Using universal safety precautions to protect self and co-workers from biohazardous materials, including blood-borne pathogens. *Assisting in special projects as assigned by laboratory management.
*BA/BS in Biology, Chemistry, BioChemistry, or related science. *10+ years of relevant experience, or an MS with 5+ years of relevant experience.
San Diego, CA
jobs@microconstants.com
4/1/2014 3:14:19 PM
Details>> Shimadzu Scientific Instruments
Field Service Engineer (HPLC) - San Jose to San Francisco
Field Service Engineer (HPLC, GC, All SSI Products) – San Jose to San Francisco Service Territory Shimadzu Scientific Instruments is one of the largest suppliers of analytical instrumentation, physical testing, and environmental monitoring systems in the world. Our products include Gas Chromatographs, Liquid Chromatographs, Mass Spectrometers, Total Organic Carbon Analyzers, UV-Vis Spectrometers, Fluorescence, Atomic Absorption, IR, X-Ray, and Universal Testing Machines. In 1975, SSI Corporate Headquarters was established in Columbia, Maryland and we currently have nine regional offices coast to coast. Corporate Mission Statement: Shimadzu Scientific Instruments will be recognized as the leader of Analytical Measurement while providing for a better quality of life. Quality People: Our most important asset. Involvement, teamwork, a commitment to excellence and fairness are the values that govern our work. Quality Products: Our products must always satisfy the needs of our customers through innovative design and unsurpassed reliability. Quality Service: Our commitment to customer support is essential for customer satisfaction. Shimadzu Scientific Instruments believes that each employee contributes directly to the growth and success of the organization and, therefore, is continuously on the search for extraordinary talent. Shimadzu Scientific Instruments is hiring a Field Service Engineer to provide service instrument support mainly in the following product areas: HPLC, GC, Spectroscopy. This is a great opportunity for someone with hands-on experience with these instruments to work in a customer facing setting who would like to advance their career! The employee will be primarily supporting the San Jose to San Francisco service territory. Position Summary: The individual in this position is responsible for a wide variety of service related support functions including, but not limited to, the repair, maintenance, and installation of assigned products. Additionally, responsibilities include the training and support of regional staff and less experienced personnel, as well as, other related duties that may be assigned from time to time. This position is responsible for the repair, maintenance and installation of assigned products sold by Shimadzu Scientific Instruments anywhere within our market area as required. Additional Functions: • Repairing, maintaining and installing those products sold by Shimadzu Scientific Instruments Inc. or its authorized representatives or suppliers anywhere within the company’s market area. • Providing technical training to customers, service and technical support personnel. • Accurate documentation and reporting of all repairs and product failures and when applicable providing design change and improvement recommendations. • Assist in the development of preventative maintenance procedures for Shimadzu Products as required. • The maintenance and control of repair parts inventories within the position’s assigned region in accordance with the administrative policies. • Providing customers and other personnel within assigned region necessary support and documentation required to effect instrument repairs, maintenance, and installations. • Repairing instruments returned to the Regional Service Center in a timely manner and provide support to less experienced service personnel in performance of the same. • Travel as required to provide service support to customers and other SSI personnel. • Ensure timely submission of all necessary reports and other required paperwork.
Knowledge Requirements: This position’s primary focus is to provide quality, efficient service to our customers and to support the other Service, Technical Support, and Sales & Marketing staff in performance of the same. Incumbent must be proficient at effectively and efficiently troubleshooting and repairing instrument problems, performing installations, and providing, when necessary, customer and staff training. Education and/or Experience: An associate’s degree in Electrical Engineering or Technology is required, a bachelors within a Life Science discipline is highly preferred. Incumbent must have at least three years of field or in-house instrumentation repair experience (or the equivalent similar product) is required. To apply, please visit our employment website (http://www.ssi.shimadzu.com/employment) Shimadzu Scientific Instruments is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.
San Jose to San Francisco
Joe Wensus, jtwensus@shimadzu.com
4/1/2014 10:57:24 AM
Details>> Bayer
Sr. Methods Validation Specialist
Description The primary responsibilities of the Sr Method Validation Specialist are to provide quality oversight of QU Validation subject matter areas: validation of analytical instruments and test method as well as validation of other systems/equipment used in the QC lab (such as temperature controlled chambers, autoclaves, glass washers, lab water systems). Also assists in maintaining validation program up to date with current regulations and industry trends. Responsibilities · Provide QA oversight for method validation activities at the site. · Review and approve QC method validation documents.• Review and approve validation documents for QC equipment from commissioning, qualification and validation activities · Assist in the establishment of method validation requirements and embedding requirements and compliance strategies into validation program documents: Validation Plans, Validation Master Plan, and Validation SOPs. · Assist and leads project teams in validation compliance activities such as: validation program compliance and efficiency improvement projects. Schedules and tracks project activities. · Resolve and approves validation discrepancies. Also, participates in discrepancy investigations related to validation failures and assess changes to methods and equipment for validation and quality impact. · Provide project team leadership including: planning and facilitating team activities. · Present in facility audits, regulatory submissions and annual product reviews. Also is SME in external regulatory audits and works with external firms on validation documentation systems. · Supervise contractors as needed.
Competencies · Validation quality assurance and compliance expert with knowledge of compendia, industry guidance and regulatory requirements. For example: ICH / ISO / ISPE / PDA •Technical Reports and CFR and international validation requirements. Strong background in analytical instrument and test method validation required. · Validation knowledge and ability to accurately review and approve documents to ensure regulatory compliance. · Knowledge of risk-based approaches to validation. · Ability to execute validation plans and drive them to completion. · Knowledge of risk-based approaches to validation. · Ability to execute validation plans and drive them to completion. · Knowledge of best practices in the industry for development engineering standards for pharma / biotech design / construction / operation / maintenance. · Demonstrated strong interpersonal skills and ability to lead teams. · Strong written and verbal skills. · Familiarity with large-scale biotech manufacturing processes including fermentation, purification, aseptic filling, lyophilization, packaging and shipping operations. · Good Manufacturing Practice (GMP) documentation experience. · Preferred Qualifications: · Advanced degree is preferred. · Some cleaning, process, equipment/system, utilities, facilities, SIP, temperature mapping and shipping validation experience desired. · Computer systems validation experience desired. Education Bachelor’s degree in Chemistry or Scientific Discipline, preferably in biological sciences. Minimum 6 years of overall experience Pharmaceutical and/or Biotechnology validation or an equivalent combination of education and experience.
Berkeley, CA
bayer.com
3/25/2014 3:30:15 PM
Details>> Nano Precision Medical
Formulation Scientist
Our ideal candidate will have the expertise and self-sufficiency to manage development of a stable formulation for a given macromolecule and to contribute to our company as a whole. Company description: Nano Precision Medical is an early-stage start-up company located in Emeryville, CA. We are developing a small, implantable device to improve treatment for people suffering from chronic diseases by providing sustained medication levels over several months without the need for injections.
NECESSARY SKILLS: - PhD preferred, Bachelor’s degree required. Preferred degree areas: Chemistry, Biochemistry, Materials Science, Biology, Bioengineering, Chemical Engineering, or other background with formulation work and/or familiarity with large molecules. - Experience with pharmaceutical formulation chemistry and techniques. - Expertise in chemistry lab techniques and analytical tools. - Excellent attention to detail. - Good communication and documentation. - Analytical trouble-shooting skills. - Flexibility. PREFERRED SKILLS: - Experience with formulation for stability of macromolecules (peptides, proteins, antibodies, etc). - Experience managing a small team. - Experience with liquid-solid material interfaces. - Experience with preclinical development, eg: PK/PD studies, toxicity studies, etc. - Familiarity with regulatory processes for pharmaceutical products. - Experience with manufacturing, scale-up of processes.
Emeryville, CA
Kayte Fischer, kayte@nanoprecisionmedical.com
3/24/2014 12:59:28 PM
Details>> Vanton Research Laboratory, LLC
Multi-task Lab Associate
We are looking for laboratory associates to perform analytical work. The responsibilities include but are not limited to the followings: 1. HPLC method development/method transfer and operations following test methods and/or SOPs 2. GMP analytical testing, protocol writing and execution, data management. 3. Prepare analytical solutions (media, buffer solutions, mobile phase solutions, etc.) 4. Sample preparations following test methods (gm to microngrams scale) 5. Perform dissolution and USP pharmaceutical testing 6. Pharmaceutical dosage form preparation 7. GMP manufacturing and production 8. Chemical, pharmaceutical and controlled substance handling and waste management
Individual who possesses BS degree or higher in Chemistry, one - three years of experiences, good team spirit, and with upbeat career mind is encouraged to apply.
Concord, CA
info@vantonlab.com
3/21/2014 1:16:20 PM
Details>> Bayer
Sr. Methods Validation Specialist
Description The primary responsibilities of the Sr Method Validation Specialist are to provide quality oversight of QU Validation subject matter areas: validation of analytical instruments and test method as well as validation of other systems/equipment used in the QC lab (such as temperature controlled chambers, autoclaves, glass washers, lab water systems). Also assists in maintaining validation program up to date with current regulations and industry trends. Responsibilities · Provide QA oversight for method validation activities at the site. · Review and approve QC method validation documents.• Review and approve validation documents for QC equipment from commissioning, qualification and validation activities · Assist in the establishment of method validation requirements and embedding requirements and compliance strategies into validation program documents: Validation Plans, Validation Master Plan, and Validation SOPs. · Assist and leads project teams in validation compliance activities such as: validation program compliance and efficiency improvement projects. Schedules and tracks project activities. · Resolve and approves validation discrepancies. Also, participates in discrepancy investigations related to validation failures and assess changes to methods and equipment for validation and quality impact. · Provide project team leadership including: planning and facilitating team activities. · Present in facility audits, regulatory submissions and annual product reviews. Also is SME in external regulatory audits and works with external firms on validation documentation systems. · Supervise contractors as needed.
Competencies · Validation quality assurance and compliance expert with knowledge of compendia, industry guidance and regulatory requirements. For example: ICH / ISO / ISPE / PDA •Technical Reports and CFR and international validation requirements. Strong background in analytical instrument and test method validation required. · Validation knowledge and ability to accurately review and approve documents to ensure regulatory compliance. · Knowledge of risk-based approaches to validation. · Ability to execute validation plans and drive them to completion. · Knowledge of risk-based approaches to validation. · Ability to execute validation plans and drive them to completion. · Knowledge of best practices in the industry for development engineering standards for pharma / biotech design / construction / operation / maintenance. · Demonstrated strong interpersonal skills and ability to lead teams. · Strong written and verbal skills. · Familiarity with large-scale biotech manufacturing processes including fermentation, purification, aseptic filling, lyophilization, packaging and shipping operations. · Good Manufacturing Practice (GMP) documentation experience. · Preferred Qualifications: · Advanced degree is preferred. · Some cleaning, process, equipment/system, utilities, facilities, SIP, temperature mapping and shipping validation experience desired. · Computer systems validation experience desired. Education Bachelor’s degree in Chemistry or Scientific Discipline, preferably in biological sciences. Minimum 6 years of overall experience Pharmaceutical and/or Biotechnology validation or an equivalent combination of education and experience.
Berkeley, CA
bayer.com
3/18/2014 9:39:02 AM
Details>> Bayer
Senior Engineering Documentation System Specialist Bayer
Description The incumbent administers the Document Management System for Engineering (EDMS). They support the processes and applications associated with EDMS as well as the system users and stakeholders. They ensure a high level of availability of the system and the consistency of all content contained in the system. The incumbent interfaces with Engineers, the Quality Unit and Engineering Project teams, both internal and external to develop functionality to support their business processes as well as to assist in Project deliverables. This is all done in a cGMP environment with close attention paid to Change Management and adherence to all Bayer and Quality systems requirements/policies Responsibilities · Work with Engineering Project Managers, Coordinators and external consultants to set up and support project work in EDMS. · Will develop business plans and strategies for improvement of the overall system by working with stakeholders and investigating new technologies. · Development of User Requirements, functional specifications, and management of the execution of the final approved plan. · Provide User and Technical support for EDMS. · Identify and analyzes system issues and develops long term, consistent solutions. · Analyze associated business processes and develops appropriate solutions in EDMS. This includes the requirements and design of a usable interface, the supporting configurations and all required documentation and training materials. · Provide technical and procedural expertise for the business processes associated with operating the system. · Organize and develops consistency to the existing data and content through generation of documented procedures. · Direct and assists projects in executing bulk loading of documents, drawings and data to EDMS · Implement improvements and procedures related to the usage of computer aided tools (CADD both 2D and 3D)) and their integration to EDMS to improve quality of work and cost effectiveness. · Work on assignments that are complex in nature where considerable judgment and initiative are required in resolving problems and making recommendations. May determine methods and procedures on new assignments and may provide guidance to other support personnel.
Competencies · Experience and knowledge of the processes and Change Management associated with Engineering Projects in a cGMP environment. · Training and experience with Documentum fundamentals and Administration. · Successful completion of Administrator training for McLaren software. · Knowledge of databases and query languages. · Working experience with McLaren Studio, McLaren DocLoader, Documentum Query Language, AutoCAD, Microstation, Excel, Access. · Extensive knowledge of the cGMP change management process and requirements as well as Change Management associated with Engineering and Safety. · Knowledge of Project Engineering processes, document types and workflows. · Completely familiar with the Engineering Commissioning/Qualification Turnover process. · Ability to analyze and transform business processes into a usable configuration in a Document Management system. The solutions must lend themselves to the overall business objectives. · Ability to support and prioritize many diverse activities simultaneously while meeting schedule commitments · Good technical/business communication skills · Good interpersonal skills Education B.S. in Computer Sciences, Engineering or other applicable B.S. discipline Specific training and certificates in Document Management systems Minimum Experience: BS 6+ years, MS 0 - 4+ years, Or an equivalent combination of education and experience. 5-8 years of experience working with and administering Document Management systems. 4 years working with Autocad software. 3-5 years working with engineering documents/drawings in a GMP change controlled environment.
Berkeley, CA
bayer.com
3/18/2014 9:28:24 AM
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