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22 days old

Associate Scientist II

Kelly Services
Spring House, PA 19477
Kelly FSP Science and Clinical is currently seeking an Associate Scientist II for a long-term engagement with one of our Global Pharmaceutical clients. This position is hybrid and onsite in Spring House, PA 3 days a week.


This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.


**Position Title** **: Associate Scientist II**


**POSITION 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 of J&J, spanning nonclinical studies to post-market clinical development.


This position is located within the Springhouse Bioanalysis Group that performs the bioanalysis of nonclinical PK and ADA to evaluate the PK/PD of new biological therapeutics. This Associate Scientist II position is responsible for the following:


1. Performs job duties with some supervision, with majority of interaction with direct supervisor and project team members

2. Collaborates effectively with fellow project members following priorities, checkpoints and timelines in support of objectives set by direct supervisor.

3. Explains work with independent analysis and conclusions related to assigned tasks through written and oral communication

4. Executes the proper operation and maintenance of bioanalytical assays and laboratory procedures.

5. Is a producer of top-level methods and robust experimental data

6. Identifies discrepancies in experimental data and assists with troubleshooting assay performance problems

7. Is up-to-date with the latest methods/techniques pertaining to functional area

8. Has a keen eye on functional process and compliance, and takes responsibility for successful execution of bioanalytical activities and compliance

9. Is savvy in the use of data management tools to record and retrieve data

10. Sets day-to day objectives and performs complex tasks and novel procedures

11. Communicates results to supervisor in a timely manner

12. 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 to Frontage Satellite Lab).


**CORE RESPONSIBILITIES:**


1. May conduct the following:

2. Independently set up bioanalytical runs based on nonclinical protocol

3. Coordinate with Trial Support to setup studies in Watson LIMS

4. Generate sample tube labels and provide the labels to the testing site

5. Track samples and reagents appropriately in Watson Laboratory Information Management System (LIMS) or Mosaic reagent management system

6. Confirm physical and virtual inventory in Watson LIMS for sample return

7. May create and place substances in Mosaic

8. Create the Bioanalysis Form and request sample lists for Bioanalysis

9. Critically review and interpret bioanalytical data (including the review of ELN experiments for peers and junior analysts)

10. Provide input for scientific experiments, analyze data and identify problems with scientific experiments in their own work or during peer review of colleagues experiments. Propose experiments for troubleshooting/identifying root cause.


+ Import and evaluate (regress) analytical run data

+ Select results and assess plate acceptance (pass/fail)

+ Identify samples for subsequent/repeat analysis

+ Identify reason for plate or sample failure (e.g. instrument issues, prep errors)

+ Identify technical errors in applicable systems (e.g. Watson LIMS template error, SoftMax Pro template error)


+ Critically review and interpret results


+ Identify the need for a deviation or note-to-file for appropriate documentation and may author applicable documents


1. 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, Softmax Pro, OpenLab)

+ Contribute bioanalytical expertise to the development of relevant systems or suggest improvements to these systems

+ Author and/or acknowledge deviation memos or notes-to-file via signature as appropriate

+ 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, Toxicology Technical Reports)

+ Critically review SOPs, BQS reports, Technical Reports and Validation/Qualification plans


1. Project Management


+ Provide task updates in Quickbase

+ Independently understand task priority


1. Independently troubleshoot equipment errors/issues and remediate

2. 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)_ :


1. Understand and present content of a journal club paper (with supervisor or mentors assistance).

2. May present own work to larger group (e.g. to BAS or BCP).

3. In-depth understanding of methods at a functional level (e.g. describe function of reagents).

4. Assist in drafting and executing peer reviewed posters, manuscripts, tech reports and patent filings.

5. Attend in-house seminars to support team goals.


**EDUCATION & EXPERIENCE GUIDELINES:**


**Education:** M.S. with 3-5 years of relevant experience or a B.S./B.A. with 4-8 years of experience, performing progressively advanced duties at the Associate Scientist I level, or the equivalent training/experience


**Experience/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 plus.


**Significant Safety or Working Considerations:**


+ May work with potentially infectious samples of human and/or animal origin

+ May handle hazardous chemicals


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-04-29 Expires: 2022-06-20

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Associate Scientist II

Kelly Services
Spring House, PA 19477

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