Scientist

Smithers•Gaithersburg, MD

3h•$70,000 - $85,000•Onsite

About The Position

Smithers PDS LLC provides bioanalytical services supporting drug development from discovery through approval and post-market surveillance. The Scientist performs data analysis and assays according to SOPs, while meeting applicable GLP, GCP, and/or CLIA requirements. The role also helps maintain laboratory areas, materials, and equipment. The Scientist conducts method transfer, development, validation, and sample testing in support of GLP studies; interprets data and prepares study summaries; and maintains secure experimental records and raw data. This is a salaried, exempt position. Employees typically work 40 or more hours to meet their responsibilities, and extended hours may be necessary to meet client deliverables. Overtime, weekend, and holiday work may be required. The position is based in Gaithersburg, Maryland, and offers a salary range of $70,000–$85,000 per year, commensurate with experience.

Requirements

Experience and knowledge of ligand-binding assays, such as ELISA or MSD, applicable to pharmacokinetic, biomarker, and immunogenicity studies.
Bachelor’s degree in biology, life sciences, or chemistry and at least 2 years of immunological assay experience; or a master’s degree in one of these fields and 1 year of immunological assay experience.
Experience in PK, ADA, and bioassays.
Excellent oral and written communication skills and strong organizational skills.
Proficiency with basic computer applications such as Microsoft Word and Excel.
Ability to multitask and produce quality analysis under strict deadlines.
Availability to work overtime, weekends, and holidays as required.

Nice To Haves

Knowledge of Watson LIMS and cell culture techniques.
Knowledge of CRO environments and experience with GLP, GCP, and/or CLIA.

Responsibilities

Adhere to laboratory health and safety procedures, SOPs, applicable company policies and guidelines, and relevant federal and local regulations, including GLP, GCP, GMP, and CLIA as applicable.
Independently perform assigned service tasks.
Perform method transfer, development, validation, and sample testing in support of GLP studies.
Interpret data and provide study data summaries.
Perform study activities in accordance with regulatory, GLP, protocol, and SOP requirements.
Maintain experimental records and raw data securely to protect data integrity.
Review and check data generated by other staff as assigned.
Represent the group in cross-departmental initiatives as needed.
Work safely with potentially hazardous substances and exercise universal precautions.
Work effectively in a team-oriented environment and independently when necessary.
Perform other assigned duties, including operational duties within areas of appropriate experience and training.
Attend continuing education courses as appropriate.