Associate Research Scientist

Smithers•Gaithersburg, MD

4h•$75,000 - $100,000•Onsite

About The Position

Smithers PDS LLC (Pharmaceutical Development Services) brings new drugs to market by providing pre-clinical and clinical services for all phases of drug development. PDS works with customers to develop new methods, validate existing methods, as well as performing the assays necessary to analyze samples from patients on more than 100 clinical trials currently in different phases of the FDA regulated drug approval process. Our expert scientists perform large molecule bioanalysis, assay development, validation, and sample analysis at our GLP, GCP, and CLIA compliant laboratories. Smithers is seeking a talented Associate Research Scientist with expertise in bioanalytical assays (PK, ADA, Nab). The individual will be responsible for design, development and feasibility of new assays.

Requirements

BA/BS in Biological or Physical Sciences and at least 3 - 5 years of relevant experience, MS in relevant field and at least 1-2 years of experience
Understanding of bioanalytical assays (various design and platforms)
Experience supporting method validation studies
Experience with assay troubleshooting
Excellent oral and written communication skills
Proficient in advanced computer applications including MS Word, Excel, statistical programs, and Watson LIMS database
Able to work independently and manage priorities, as well as operate as a team member
Must be solution oriented and open to input
Must be able to comfortably and successfully operate in a dynamic environment with shifting priorities
Must be able to collaborate and partner at all levels of the organization to accomplish deliverables and meet quality standards

Nice To Haves

Prior CRO and GLP, GCP, and/or CLIA experience a plus
Experience with automated laboratory systems a plus
Experience in drafting SOPs a plus

Responsibilities

Design, development and feasibility of new assays.
Adherence to laboratory health and safety procedures
Adherence to Standard Operating Procedures (SOPs)
Adherence to applicable company policies and guidelines
Adherence to federal and/or local regulations, as applicable
Ensures appropriate reporting when there is reason to believe compliance with regulations, policies, guidelines, SOPs, quality, or other criteria are not being observed or enforced
Ensure materials and equipment are maintained
Assist with training and provide technical guidance to more junior scientists as needed