This is a technical position within the Bio analytical Sciences group. This group is responsible for developing, validating, and conducting bio-analytical methods related to large molecule bio-therapeutic drug development across all therapeutic areas of J&J, spanning nonclinical studies to post-market clinical development.
The Associate Scientist II may assist with all aspects of bio-analysis. Bio-analytical methods may include ligand binding assay formats, DNA Extraction methods and q-PCR methods.
The Associate Scientist II understands and executes ligand binding assay and qPCR method development experiments, validations, data analysis, and reporting as required. Participates in experimental data review, method validation, method transfer, reagent qualifications and method troubleshooting. The Associate Scientist II will utilize automated liquid handling systems as technology becomes available at JBIO-BBL. The Associate Scientist II also utilizes Laboratory Information Management Systems (LIMS), electronic lab notebook systems, and data analysis with SoftMaxPro (as needed). Maintains compliance/training in a regulated GLP/GcLP environment. May assist in writing standard operating procedures and technical reports. Works with critical chain project management methodology. Maintains routine lab operations/equipment and safe work conditions. Contributes to the development of a variety of biologic products relating to diverse human disease states. Responsible for good communication and organization skills, equipment ownership and maintenance in a GLP/GcLP lab environment, and GLP/GcLP compliance.
1. Executes experimental plans for bioanalytical method development, transfers, validations, bioanalysis and troubleshooting with day-to-day autonomy.
2. Other duties according to Performance Expectations.
PERFORMANCE EXPECTATIONS ACCORDING TO JANSSEN R&D (SCIENTIFIC CAREER LADDER):
The Associate Scientist II, within JBIO-BBL, will:
3. Set day-to-day objectives and perform more complex tasks and novel procedures
4. Work with day-to-day autonomy
5. Act as an individual contributor but may guide others on a team on processes, techniques or tasks
6. Recommend increasingly complex modifications to existing systems, processes, techniques or programs for improvement
7. Explain work with independent analysis and conclusions related to assigned tasks through written and oral communication
8. Interact with immediate supervisor and project team members/leaders
9. Perform assigned scientific experiments with decreasing level of supervisor’s assistance
10. Provide input and identify problems with scientific experiments, analyses/tasks in related areas
11. Maintain current laboratory equipment and operate analytical and other instruments
12. Assist in developing recommendations for improving standard procedures
13. Maintain accurate record keeping and experimental data with the use of statistical packages and standard databases
14. Draft technical reports and contribute to information management, manuscripts, patent applications, etc.
15. Communicate results to supervisor in a timely manner
16. Support the work of project members to accomplish team objectives on time and within budget
17. May place orders in purchasing systems or maintain supplies to proactively support projects
This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.
1. Attend in-house seminars and local/regional scientific meetings in own field
2. Present own work to members of department or external consultants as needed
EDUCATION & EXPERIENCE GUIDELINES:
Education: M.S. with 3-5 years of experience or a B.S./B.A. with 3-5 years of experience, performing progressively advanced duties at the Associate Scientist I level, or the equivalent training/experience
Experience within ligand binding assay and qPCR method development is highly desirable.
Significant Safety or Working Considerations:
•May work with potentially infectious samples of human and/or animal origin
•May handle hazardous chemicals
Janssen Pharmaceutica N.V. (7555)