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Precision Medicine Group

Principal Scientist (Bioanalytical)

Precision Medicine Group, Frederick, Maryland, United States, 21701


Precision for Medicine

is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe. Won't you join us today as a

Principal Scientist, Bioanalytical?

Position Summary:

The Principal Scientist supervises laboratory staff to support bioanalytical activities. Lead Bioanalysis and Biomarker projects through assay design and development, validation, and execution in a timely manner. Perform assays according to SOPs and support technology development in Ligand Binding platform.

Essential functions of the job include but are not limited to:

Design and perform experiments, independently and accurately analyze and present data

Provide high quality output with the ability to build efficiency into improving productivity metrics

Serve as Technical Lead in Ligand Binding Platform

Assist in establishing and improving all procedures and required SOP documentation

Responsible for assay troubleshooting and correcting routine scientific issues/problems

Identify, update and implement emerging laboratory techniques

Maintain and support lab safety practices and environment

Work collaboratively with other technical teams in resource sharing and providing technical expertise

Support new equipment operational qualifications and performance checks

Monitor Lab Service/R&D related project expenses

Act as a scientific resource externally to clients and internally

Assist with writing, reviewing and editing contract and grant applications/proposals as appropriate

Assist with writing and publishing papers, abstracts, techniques/or chapters to maintain the scientific standard and image of the company.

May present completed work at appropriate scientific meetings and in publications

Supervision of assigned laboratory staff to ensure efficient organization, development and execution of project(s)

Other duties as assigned

Qualifications:

Minimum Required:

Must have a Ph.D. in life sciences or relevant field in life sciences

At least 8 years of full-time post-doctoral laboratory experience

Other Required:

Strong background in various technology platforms such as Mesoscale Discovery, Quanterix, Luminex, ELISA.

Ability to troubleshoot and refine bioanalysis and biomarkers assays such as ADA, PK, Potency Assay, Cytokine and PD biomarker measurement

Experience in handling various sample matrix such as whole blood, plasma/serum, cell pellets/supernatant, urine and CSF

Excellent communication, interpersonal, and organizational skills required.

Must have the ability to organize and analyze data, as well as prepare technical reports.

Must possess strong computational skills, preferably experienced with Softmax, MSD BenchWork, Word, Excel, Power Point, GraphPad Prism

Excellent use of judgment and discretion required

Extended work hours may be occasionally necessary in order to meet business demands

Ability to lift and carry between 1-15 lbs.; Ability to lift up to 50 lbs. overhead with assistance; frequently required to sit, grasp, and use right/left finger dexterity; May be exposed to a cold freezer environment (Freezer temperatures range between -20ºC -196ºC)

Must be able to read, write, speak fluently and comprehend the English language

Preferred:

A solid understanding of current bioanalytical method validation standards

Experience supervising or mentoring scientists or technical personnel

Previous work experience in GLP or GCLP or CLIA regulatory compliance

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