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21 days old

Scientist IV

Kelly Services
Spring House, PA 19477
Kelly is hiring a **Scientist IV** for one of our clients in **Spring House, PA**


+ 2 year contract

+ pay: negotiable

+ Remote for time being but will be onsite post COVID


Description:


The Clinical Team Bioanalytical (BA) Scientist Group serves as the BAS responsible scientist for execution of study bioanalysis for assigned clinical programs. Serves as an individual contributor for: development of BA strategies and BA plans for all phases of clinical programs, oversight of study BA timings and data review. The position serves as a primary BAS contact for interactions with internal functional teams (including Project Management, Trial Support and Laboratory Support) and clinical stakeholders [including Clinical Pharmacology and Pharmacometrics (CPP), clinical teams (CTs), cross-functional trial teams (CFTTs), Compound Development Teams (CDTs) and Chemistry, Manufacturing and Controls (CMC) teams] to ensure two-way communication of information necessary for delivering BASs regulatory submission-related projects. The position requires the use of experience in bioanalytical sciences to guide the formation of bioanalytical strategies and resolutions of project related BA issues. Technical leadership and project management requirements are below.


CORE RESPONSIBILITIES:

Clinical Team Bioanalytical Representative (Temp)

Serve as the subject matter expert on the science and process of study bioanalysis.

Accountable for documenting BA strategies (e.g. selection of analytes, desired assay attributes, applicable matrices, and validation strategies etc.) for all phases of clinical programs.

Accountable for documenting and communicating BA plans to clinical project teams.

Guide continuous validation strategies for product life cycle (e.g., for new indications, assay placement, combination studies, etc.)

Review and contribute to study protocol PK, target engagement, and immunogenicity sampling time points.

Educate stakeholders on rationale for BA strategies, assay design, and experimental progress (as appropriate).

Proactively communicate with clinical portfolio project leadership to ensure that operational and scientific needs of projects are met by team.

Contribute to centralized and streamlined communication tools and processes to enable consistency of communication and BAS information sharing with project stakeholders.

Serve as single point of contact for Cross Functional Trial Teams (for internal work) or to the appropriate partner representatives for collaborative studies (for external work), Project Managers and Compound Development Team (CDT) for bioanalytical related questions, concerns, issues, timelines, etc.

Review all supply agreements, study protocols and regulatory submissions pertaining to sampling and bioanalytical test, central lab SOWs, Data Flow diagrams, and Laboratory Manuals.

Communicate overall strategy of the projects to others

May serve as the liaison between team members and senior leadership


**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: 2021-03-31 Expires: 2021-05-01

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Scientist IV

Kelly Services
Spring House, PA 19477

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