Scientist IV

Kelly Services - Spring House, PA3.9

Temporary
Seeking a Scientist IV for a 2 year assignment in Spring House, PA.

Job Description: Applying multiple years of clinical testing laboratory experience, this position has a leadership role in Bioanalytical sample testing activities in support of Clinical studies. Specifically, the successful candidate will have daily participation in PK/PD and biomarker analyses, review and approval of results in LIMS, method improvements and new method dev/val., and authoring/reviewing SOP, protocols and reports. There is an expectation of on-going contribution/ownership to process improvements targeting compliance, efficiency and productivity.

Major Duties Responsibilities: - Perform approver role in LIMS for Clinical sample testing activities. Manage inventory and testing status of clinical samples using LIMS data base systems. - Supervise and maintain laboratory activities in compliance with GMP, GLP or other appropriate regulations. - Responsible for any of writing/revising/reviewer role for SOP, protocols and reports. Assist in the review and reporting of data for submission to IND s and other regulatory submissions, pre-clinical and clinical study reports. - Support BLA documentation specific to Bioanalytical, Pre-approval inspection readiness, FDA audit SME for bioanalytical. - Analyte quantification method development, validation, method transfers and comparability. Method improvements to reduce total error and to establish stability of analyte, QC, immunoreagents and buffers. Qualification of new lots: Reference standards, new kits, new conjugates. - Mentor analysts, train new employees, and evaluate/anticipate equipment needs and lab maintenance issues. - On-going contributions and ownership of Lean Processes targeting Compliance, Efficiency and Productivity. - Review employee activities and evaluate their performance for any direct reports. - Perform other work related duties as assigned.

Other Duties: - Knowledgable of GLP required, knowledgable of cGMP strongly preferred. - Strong preference for experience with LabWare LIMS. - Skilled at scientific writing: protocols, reports and SOP, proven experience in method validation and method transfers. - Experience in training analysts. - Computer proficiency is essential in MS Word, Excel.

Required Minimum Education: 10+ years. Required Knowledge, Skills Abilities: - LabWare LIMS preferred, Proficient in MS Word and Excel. - 7+ years of people management experience. Preferred Minimum Education: PhD in Biochemistry, Cell Biology, Chemistry. Preferred Related Industry Experience: biotechnology or pharmaceutical. Preferred Knowledge, Skills Abilities: Knowledgable of QControl and QAssurance roles and responsibilities in GLP and GMP environment.

APPLY NOW!

For immediate consideration please call 732-246-0215 or email to gaut985@kellyservices.com

Why Kelly®?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations— providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly Services®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.