Job ID: 5740
Job date: 2016-07-09
End Date:
Company : Halozyme Therapeutics, Inc. Country : Role : Research Scientist
Job date: 2016-07-09
End Date:
Company : Halozyme Therapeutics, Inc. Country : Role : Research Scientist
Job Description:
Save time and apply through your LinkedIn account. Click the Apply with LinkedIn button and your LinkedIn profile will be imported into our site.
In order to move forward, you will need to create an account. Your password must be eight characters long, contain at least one special character, one capital letter and a number.
We look forward to discovering your talents.
POSITION SUMMARY:
The Senior Research Scientist 2 will develop Biomarker strategies to support nonclinical, early stage clinical (Phase 1) and/or GLP toxicology studies including bioinformatics assessments and statistical evaluations. The Senior Research Scientist 2 will prepare relevant technical reports for regulatory filings, partner support, business development, academic collaborations and/or Clinical Study Reports.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include, but are not limited to:
Assist research studies by application of bioinformatics concepts and methods towards areas such as oncology, computational biology, and ‘omics’ based systems. Help develop algorithms for processing and analyzing genomics, transcriptomics, proteomics, or metabolomics information. Evaluate and execute work packages in fields such as assay development, validation, transfer, implementation, build-up of new technology platforms. Implementation/prioritization of biomarker testing development plans for nonclinical and early stage clinical support including hypothesis testing. Work collaboratively to support Clinical Pharmacology and Biomarker Discovery efforts as well as Halozyme’s scientific staff to develop and deliver cutting edge bioinformatics strategic solutions. Review specific analytical biomarker method(s); technical assessments with Contract Research Organizations (CRO), coordinate with Legal and Finance to ensure proper funding of activities. Support for CRO auditing and ongoing data surveillance. Prepare data, figure and contribute to authoring of manuscripts for publication. Prepare documents for submission to regulatory authorities (e.g., Technical Reports, Clinical Study Reports), business partners, and Halozyme Clinical teams. Document experimental work as required by current Halozyme SOPs and regulatory filings (primarily US and EU). Participate in cross-functional project team meetings, provide feedback on experimental work completed and help determine strategies for accomplishing relevant goals. Enhance professional growth and development through participation in educational programs, current literature, in-service meetings and workshops. Comply with Halozyme policy, procedures, objectives, quality assurance program, safety and environmental standards.
ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
Technical support of pharmacology and toxicology groups as required. Establish and maintain extramural relationships with academic scientists and professional organizations. Other functions and duties as assigned.
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:
Life science PhD with 5+ years or BA / BS with equivalent years of experience in Bioinformatics, Systems Biology, or Life Sciences with an emphasis on Bioinformatics. . Strong background in quantitative biology, such as statistics, bioinformatics and a reasonable working knowledge of cancer genomics, molecular biology, and ‘omics’ data processing (i.e., proteomics, transcriptomics, metabolomics, and clinical bioinformatics). Experience with public access and commercially available bioinformatics tools and with statistical/mathematical modeling. Demonstrated hands-on experience in protein-based biomarker testing algorithms and analyses. Preferred knowledge/experience with protein based biotherapeutics. Strong familiarity with GxP regulations, applicable Regulatory Guidance, and Industry White Papers. Track record of peer-reviewed publications in journals focused on clinical translational and biomarker research. Expertise of standard technologies and new technology platforms used for biomarker assessments including NGS (genomics, transcriptomics), proteomics, RT-qPCR, FACS, and ELISA. Strong interpersonal skills including effective time management, organization and decision-making skills. Outstanding written/verbal communication and presentation skills. Excellent leadership and communication skills. TECHNICAL KNOWLEDGE REQUIRED: Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other equipment required: not applicable. Software Knowledge : Windows, MS Office (Outlook, Word, Excel, PowerPoint). Knowledge of other software required: GraphPad Prism, SoftMax Pro, MSD Workbench, and JMP INTERNAL AND EXTERNAL RELATIONSHIPS: Internal interaction with the Pharmacology, Vivarium, Biotherapeutics Development, Preclinical and Regulatory groups is required. External interaction with academic labs and CROs may be required. EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS: Physical Activities : On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply. TRAVEL : Travel may be required up to 5% of your time.
Additional Info:
[Click Here to Access the Original Job Post]
Save time and apply through your LinkedIn account. Click the Apply with LinkedIn button and your LinkedIn profile will be imported into our site.
In order to move forward, you will need to create an account. Your password must be eight characters long, contain at least one special character, one capital letter and a number.
We look forward to discovering your talents.
POSITION SUMMARY:
The Senior Research Scientist 2 will develop Biomarker strategies to support nonclinical, early stage clinical (Phase 1) and/or GLP toxicology studies including bioinformatics assessments and statistical evaluations. The Senior Research Scientist 2 will prepare relevant technical reports for regulatory filings, partner support, business development, academic collaborations and/or Clinical Study Reports.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include, but are not limited to:
Assist research studies by application of bioinformatics concepts and methods towards areas such as oncology, computational biology, and ‘omics’ based systems. Help develop algorithms for processing and analyzing genomics, transcriptomics, proteomics, or metabolomics information. Evaluate and execute work packages in fields such as assay development, validation, transfer, implementation, build-up of new technology platforms. Implementation/prioritization of biomarker testing development plans for nonclinical and early stage clinical support including hypothesis testing. Work collaboratively to support Clinical Pharmacology and Biomarker Discovery efforts as well as Halozyme’s scientific staff to develop and deliver cutting edge bioinformatics strategic solutions. Review specific analytical biomarker method(s); technical assessments with Contract Research Organizations (CRO), coordinate with Legal and Finance to ensure proper funding of activities. Support for CRO auditing and ongoing data surveillance. Prepare data, figure and contribute to authoring of manuscripts for publication. Prepare documents for submission to regulatory authorities (e.g., Technical Reports, Clinical Study Reports), business partners, and Halozyme Clinical teams. Document experimental work as required by current Halozyme SOPs and regulatory filings (primarily US and EU). Participate in cross-functional project team meetings, provide feedback on experimental work completed and help determine strategies for accomplishing relevant goals. Enhance professional growth and development through participation in educational programs, current literature, in-service meetings and workshops. Comply with Halozyme policy, procedures, objectives, quality assurance program, safety and environmental standards.
ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
Technical support of pharmacology and toxicology groups as required. Establish and maintain extramural relationships with academic scientists and professional organizations. Other functions and duties as assigned.
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:
Life science PhD with 5+ years or BA / BS with equivalent years of experience in Bioinformatics, Systems Biology, or Life Sciences with an emphasis on Bioinformatics. . Strong background in quantitative biology, such as statistics, bioinformatics and a reasonable working knowledge of cancer genomics, molecular biology, and ‘omics’ data processing (i.e., proteomics, transcriptomics, metabolomics, and clinical bioinformatics). Experience with public access and commercially available bioinformatics tools and with statistical/mathematical modeling. Demonstrated hands-on experience in protein-based biomarker testing algorithms and analyses. Preferred knowledge/experience with protein based biotherapeutics. Strong familiarity with GxP regulations, applicable Regulatory Guidance, and Industry White Papers. Track record of peer-reviewed publications in journals focused on clinical translational and biomarker research. Expertise of standard technologies and new technology platforms used for biomarker assessments including NGS (genomics, transcriptomics), proteomics, RT-qPCR, FACS, and ELISA. Strong interpersonal skills including effective time management, organization and decision-making skills. Outstanding written/verbal communication and presentation skills. Excellent leadership and communication skills. TECHNICAL KNOWLEDGE REQUIRED: Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other equipment required: not applicable. Software Knowledge : Windows, MS Office (Outlook, Word, Excel, PowerPoint). Knowledge of other software required: GraphPad Prism, SoftMax Pro, MSD Workbench, and JMP INTERNAL AND EXTERNAL RELATIONSHIPS: Internal interaction with the Pharmacology, Vivarium, Biotherapeutics Development, Preclinical and Regulatory groups is required. External interaction with academic labs and CROs may be required. EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS: Physical Activities : On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply. TRAVEL : Travel may be required up to 5% of your time.
Requeriments :
Skills :
Areas :
Additional Info:
[Click Here to Access the Original Job Post]