Scientist

Smithers; Gaithersburg (MD); On-site; USD 70,000 - 85,000; Full time

Benefits offered by this job

Health insurance

Dental plan

Vision plan

401K retirement plan

PTO

Job summary

Smithers PDS LLC (Pharmaceutical Development Services) seeks a Scientist to join our Gaithersburg, MD team. The role centers on data analysis and performing assays in accordance with SOPs while meeting GLP, GCP, and CLIA requirements.

The incumbent will help ensure the lab, materials, and equipment are properly maintained and compliant. This exempt, salaried position typically expects 40+ hours, with extended hours as needed to meet client deliverable commitments.

Qualifications

• Experience with ligand-binding assays used in PK, biomarker and immunogenicity studies.
• Proficient data analysis and data interpretation for GLP studies.
• Familiarity with regulatory requirements (GLP, GCP, CLIA).

Responsibilities

• Perform analysis including method transfer, development, validation and sample testing for GLP studies.
• Provide data summaries and interpretations for studies.
• Maintain lab materials and equipment and ensure safe operation and compliance.
• Review data generated by team members and support cross-department initiatives.
• Work independently and in a team-oriented environment to meet client deliverables.

Skills

Ligand-binding assays

ELISA/MSD

Data analysis

GLP/GCP/CLIA knowledge

Watson LIMS

Education

BA/BS in biology, life sciences, or chemistry

MS in biology, life sciences, or chemistry

Tools

Watson LIMS

Job 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.

This position is salaried and is classified as an exempt position. Exempt employees typically work 40 hours or more to adequately perform their responsibilities. Extended work hours may be necessary to support the business in meeting client deliverable commitments.

The salary range for the role is $70,000 - $85,000 per year commensurate with experience. Smithers PDS has a comprehensive health insurance package including a choice of 3 medical plans, dental, vision, 401K retirement plan and PTO.

Corporate 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.).

Essential Position Responsibilities:

• 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.

Job 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.
• Overtime, weekend and holiday work as required.

Professional Responsibilities: (if applicable)

• Attend continuing education courses, as appropriate.

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