CDx Development Staff Scientist at Roche in Tucson, AZ
POSITION
Summary:
Responsible for initiating, directing and executing scientific research, development and manufacturing process strategies to support new and existing companion diagnostic (CDx) products. Position will primarily involve testing new CDx markers to fulfill the established feasibility requirements of CDx, including specificity, sensitivity and stability of potential new products. Applies a wide variety of scientific principles and concepts to potential inventions, products and problems related to CDx portfolio. Plans and executes laboratory research. Maintains broad knowledge of state-of-the art principles and theories. Serves as an in-house and outside consultant, in particular acts as a technical liaison to project management group and may also be required to interact directly with pharma clients as necessary. Promotes and participates in the professional development of scientists and laboratory facilities. Uses professional concepts to contribute to the development of product or process principles and to achieve objectives in creative and effective ways.
Essential Functions:
Conceives, designs, conducts and leads advanced independent or multi-disciplinary research driven by strategic business needs in compound, assay, process, product, method or system integration development. Project goals are broadly defined; defines project milestones; responsible for timely project completion. Makes major contributions to strategic directions and projects through knowledge of technology and its creative applications. Drives activities for publication and/or patent potential. Conceives, plans, and executes projects related to the strategic needs of the company. Designs and executes experiments to test hypothesis related project outcomes; extracts the full relevance of scientific observations. Applies advanced scientific knowledge to multi-disciplinary projects. Assures experimental quality through sound experimental design; utilizes DOE; assists in the design of experiments for others. Participates or leads cross functional technical teams such as a failure investigation or core team. Develops and maintains internal and external contacts to maintain technical knowledge. Trains others using a variety of methods on the theoretical and practical basis of techniques, processes and products. Participates or leads in project planning, process updates and contributes to experimental design. Presents results of projects both internally and externally. Reviews and critiques presentation for others; presents complex technical data to large and diverse groups. Monitors work to ensure quality, and continuously promote Quality First Time. MINIMUM
Qualifications:
Formal Training/Education and
Experience:
Ph.D. in Science with 3
years or M.S with 5
years, or Bachelor's degree with 8
years relevant experience. Knowledge, Skills, and Abilities:
oExpert knowledge and application of scientific principles and concepts, particularly IHC (immunohistochemistry). oAbility to interpret IHC staining results on human tissue sections highly desirable. oProtein chemistry experience and antibody and epitope characterization techniques highly desirable. oApplies advanced technical writing skills to produce reports and documents; writes independently; evaluates the writing of others. oPrior experience with Pharmaceutical Companion Diagnostic (CDx) assay development on Roche automated platforms or equivalent. o Minimum of 6 years experience with various Roche/Ventana automated immunohistochemistry platforms or equivalent, including modifying staining protocols, instrument troubleshooting and maintenance. o Prior experience with cGMP level documentation practices and working in an FDA-regulated medical device environment.
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Summary:
Responsible for initiating, directing and executing scientific research, development and manufacturing process strategies to support new and existing companion diagnostic (CDx) products. Position will primarily involve testing new CDx markers to fulfill the established feasibility requirements of CDx, including specificity, sensitivity and stability of potential new products. Applies a wide variety of scientific principles and concepts to potential inventions, products and problems related to CDx portfolio. Plans and executes laboratory research. Maintains broad knowledge of state-of-the art principles and theories. Serves as an in-house and outside consultant, in particular acts as a technical liaison to project management group and may also be required to interact directly with pharma clients as necessary. Promotes and participates in the professional development of scientists and laboratory facilities. Uses professional concepts to contribute to the development of product or process principles and to achieve objectives in creative and effective ways.
Essential Functions:
Conceives, designs, conducts and leads advanced independent or multi-disciplinary research driven by strategic business needs in compound, assay, process, product, method or system integration development. Project goals are broadly defined; defines project milestones; responsible for timely project completion. Makes major contributions to strategic directions and projects through knowledge of technology and its creative applications. Drives activities for publication and/or patent potential. Conceives, plans, and executes projects related to the strategic needs of the company. Designs and executes experiments to test hypothesis related project outcomes; extracts the full relevance of scientific observations. Applies advanced scientific knowledge to multi-disciplinary projects. Assures experimental quality through sound experimental design; utilizes DOE; assists in the design of experiments for others. Participates or leads cross functional technical teams such as a failure investigation or core team. Develops and maintains internal and external contacts to maintain technical knowledge. Trains others using a variety of methods on the theoretical and practical basis of techniques, processes and products. Participates or leads in project planning, process updates and contributes to experimental design. Presents results of projects both internally and externally. Reviews and critiques presentation for others; presents complex technical data to large and diverse groups. Monitors work to ensure quality, and continuously promote Quality First Time. MINIMUM
Qualifications:
Formal Training/Education and
Experience:
Ph.D. in Science with 3
years or M.S with 5
years, or Bachelor's degree with 8
years relevant experience. Knowledge, Skills, and Abilities:
oExpert knowledge and application of scientific principles and concepts, particularly IHC (immunohistochemistry). oAbility to interpret IHC staining results on human tissue sections highly desirable. oProtein chemistry experience and antibody and epitope characterization techniques highly desirable. oApplies advanced technical writing skills to produce reports and documents; writes independently; evaluates the writing of others. oPrior experience with Pharmaceutical Companion Diagnostic (CDx) assay development on Roche automated platforms or equivalent. o Minimum of 6 years experience with various Roche/Ventana automated immunohistochemistry platforms or equivalent, including modifying staining protocols, instrument troubleshooting and maintenance. o Prior experience with cGMP level documentation practices and working in an FDA-regulated medical device environment.
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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