- 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.
- Knowledge of Watson LIMS and cell culture techniques a plus.
- Perform other duties as assigned including operational duties in areas of appropriate experience and training.
- BA/BS in biology, life sciences, or chemistry field and at least 2 years of experience in immunological assay development; 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.
- Overtime, weekend and holiday work as required.
- Attend continuing education courses, as appropriate.
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Scientist - Gaithersburg, United States - Smithers
Description
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.
Corporate Responsibilities:
#LI-MV2
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR c)
