Scientist

Smithers PDS LLC; Gaithersburg (MD); Presencial; USD 70.000 - 85.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Dental and vision plans

401K retirement plan

PTO

Descripción de la vacante

Smithers PDS LLC (Pharmaceutical Development Services) in Gaithersburg, MD is seeking a Scientist to perform data analysis and various assays in a GLP/GCP/CLIA compliant laboratory. The role involves method development, validation, sample testing, and data interpretation to support regulatory submissions.

The ideal candidate has a BA/BS in biology or chemistry (MS preferred) and experience with immunological assays, plus strong communication and organizational skills.

Formación

• Experience with immunological assays and data analysis
• Strong communication and organizational skills
• Proficiency with MS Word and Excel
• Ability to multi-task and meet deadlines (GLP/GCP/CLIA)

Responsabilidades

• Perform data analysis and reporting per SOP while meeting GLP, GCP, and CLIA requirements
• Support method transfer, development, validation and sample testing for GLP studies
• Maintain laboratory records and ensure data integrity
• Collaborate with team to ensure compliance with SOPs and safety procedures
• Assist with equipment/materials maintenance and lab operations

Conocimientos

Immunoassays

Data analysis

Communication

Teamwork

Educación

BA/BS in biology or chemistry

MS in biology or chemistry

Herramientas

Watson LIMS

Descripción del empleo

If you are a job seeker with a disability and require a reasonable accommodation to apply for one of our jobs, you will find the contact information to request the appropriate accommodation by visiting the following our Accessibility Accomodation for Applicants page.

Scientist

• Posted on November 4, 2026

Locations

Showing 1 location

Gaithersburg, MD 20878, USA

• On-site
• Operations
• Full-Time
• Requisition #: SCIEN002449

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.).
• 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.
• 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.

#PharmaJobs

#LI-MV1

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.