Job Description Associate Scientist / ScientistPOSITION SUMMARY:
This is a technical scientific position within the Study Bioanalysis Team. The Study Bioanalysis Team is responsible for conducting bioanalytical methods related to large molecule biotherapeutic drug development across all therapeutic areas, spanning nonclinical studies to post-market clinical development.
The Bioanalysis Group performs the stat bioanalysis of clinical PK and sTE samples to evaluate the PK/PD of new biological therapeutics. This Bioanalysis Group also performs ADA and NAb analysis. This Scientist position is responsible for the following:
- Performs job duties with some supervision, with majority of interaction with direct supervisor and project team members
- Collaborates effectively with fellow project members following priorities, checkpoints and timelines in support of objectives set by direct supervisor.
- Explains work with independent analysis and conclusions related to assigned tasks through written and oral communication
- Executes the proper operation and maintenance of bioanalytical assays and laboratory procedures.
- Is a producer of top-level methods and robust experimental data
- Identifies discrepancies in experimental data and assists with troubleshooting assay performance problems
- Is up-to-date with the latest methods/techniques pertaining to functional area
- Has a keen eye on functional process and compliance, and takes responsibility for successful execution of bioanalytical activities and compliance
- Is savvy in the use of data management tools to record and retrieve data
- Sets day-to day objectives and performs complex tasks and novel procedures
- Communicates results to supervisor in a timely manner
Directly participates in the delivery of broader research efforts by acting as a flexible resource, supporting other functional areas and providing scientific input (e.g. assist Assay Development, Validation and troubleshooting, Assay Transfers).CORE RESPONSIBILITIES:
- May conduct the following:
- Independently set up bioanalytical runs
- Prepare samples manually or via Hamilton Liquid Automation
- Perform assay steps manually or via Hamilton Liquid Automation
- Track samples and reagents appropriately in Watson Laboratory Information Management System (LIMS) or Mosaic reagent management system
- Confirm physical and virtual inventory in Watson LIMS for sample return
- Critically review and interpret bioanalytical data (including the review of ELN experiments for peers and junior analysts)
- May create and place substances in Mosaic
- Perform bioanalysis on an as needed basis
- Maintain accurate record keeping and experimental data with the use of data analysis packages and standard databases
- Maintain real-time documentation in all applicable systems (Symyx ELN, Mosaic, Watson LIMS, OpenLab)
- Contribute bioanalytical expertise to the development of relevant systems or suggest improvements to these systems
- Author deviation memos or notes-to-file
- May write, review, and execute validation documents for Softmax Pro and/or Excel
- May create and review Symyx ELN templates
- May author/co-author technical reports (SOPs, BQSs, ISR/Para Vals)
- Critically review SOPs, BQS reports, technical reports and Validation/Qualification plans
- Maintain Good Laboratory Practice (GLP) compliance for all work and documentation
This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned OTHER RESPONSIBILITIES
(if any) :
- May present own work to larger group.
- In-depth understanding of methods at a functional level (e.g. describe function of reagents).
- Assist in drafting and executing peer reviewed posters, manuscripts, tech reports and patent filings.
Attend in-house seminars to support team goals.EDUCATION & EXPERIENCE GUIDELINES:Education:
M.S. with 1-5 years of relevant experience for Scientist or a B.S./B.A. with 1-5 years of experience for Associate Scientist, performing progressively advanced duties at the Associate Scientist I level, or the equivalent training/experienceExperience/Special Skills:
Experience with MesoScale Discovery®, GYROS®, Hamilton Liquid Automation platforms is a plus. Experience with the Watson Laboratory Information System and an electronic notebook is a plusSignificant Safety or Working Considerations:
- May work with potentially infectious samples of human and/or animal origin
May handle hazardous chemicals
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.