Scientist

Smithers•Gaithersburg, MD

5d•$70,000 - $85,000•Onsite

About The Position

Smithers PDS LLC (Pharmaceutical Development Services) assists in the development of new medicines by providing bioanalytical services for all phases of drug development from discovery through approval and post market surveillance. 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 PDS is seeking a Scientist to join our team in Gaithersburg, MD. The Scientist performs data analysis and various assays according to SOP with reliability while applying and meeting GLP, GCP, and/or CLIA requirements. This position assists with ensuring that the lab, materials, and equipment are maintained.

Requirements

BA/BS in biology, life sciences, or chemistry field and at least 2 years of experience in immunological assay; or
MS in biology, life sciences, or chemistry field and 1 year of experience in immunological assays; or
Knowledge of CRO and GLP, GCP, and/or CLIA experience preferred.
Experience in PK, ADA, and Bioassays
Excellent communication skills, both oral and written, and strong organizational skills.
Proficient in the use of basic computer applications such as MS Word and Excel.
Ability to multi-task and produce quality analysis while working under the pressure of strict deadlines.

Nice To Haves

Knowledge of Watson LIMS and cell culture techniques a plus.

Responsibilities

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 (GLP, GCP, GMP, CLIA, etc.).
Experience and knowledge of Ligand-binding assays (e.g. ELISA / MSD) applicable to Pharmacokinetic, Biomarker and Immunogenicity studies is required.
Independently perform service tasks as directed.
Perform analysis including method transfer, development, validation and sample testing in support of GLP studies.
Responsible for data interpretation and provide data summaries for studies.
Perform study activities to meet the regulatory, GLP, protocol, and SOP requirements.
Maintain the experimental records and raw data in a secure way to protect the integrity of the data.
Review and check data generated by other staff as assigned.
May represent group in cross departmental initiatives.
Work safely with potentially hazardous substances, exercise universal precautions.
Function effectively in a team-oriented atmosphere and work independently when necessary.
Perform other duties as assigned including operational duties in areas of appropriate experience and training.
Attend continuing education courses, as appropriate.