Scientist

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

Benefits offered by this job

Health insurance

Dental and vision plans

401K retirement plan

PTO

Job summary

Smithers PDS LLC in Gaithersburg, MD is seeking a Scientist to perform data analysis and immunoassays in GLP/GCP/CLIA compliant labs, supporting PK, biomarker, and immunogenicity studies.

The role is salaried and exempt, requiring 2+ years of immunological assay experience; responsibilities include method transfer/validation, data interpretation, and maintaining study records. Salary range: $70,000-$85,000 with comprehensive benefits.

Qualifications

• BA/BS in biology, life sciences, or chemistry with 2+ years of immunological assay experience.
• MS in biology, life sciences, or chemistry with at least 1 year of immunological assay experience.
• Experience with CROs and GLP, GCP, CLIA environments preferred.

Responsibilities

• Perform Ligand-binding assays (ELISA/MSD) for PK, Biomarker and Immunogenicity studies.
• Transfer, develop, validate, and test methods for GLP studies.
• Interpret data and provide summaries for studies.
• Maintain study records and raw data with data integrity.
• Ensure compliance with SOPs, safety and regulatory requirements.

Skills

Immunoassays

Data analysis

Laboratory techniques

MS Word

MS Excel

Education

BA/BS in biology or chemistry

MS in biology or life sciences

Tools

MS Word

MS Excel

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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