Scientist

Job Title: Biotherapeutics Scientist Analytical Characterization
Location: Wayne, PA 19087
Duration: 1 Year (Possible Extension) (W2, No Benefits)

Position Summary:

The Scientist will support the development, optimization, and execution of analytical methods for the testing and characterization of biotherapeutics in both R&D and cGMP environments. The role involves performing analytical testing, method validation, data analysis, and client interaction while maintaining regulatory compliance and scientific excellence.

Key Responsibilities:

• Perform and troubleshoot analytical laboratory experiments for the characterization of biotherapeutics.
• Execute routine and advanced testing using methodologies such as:
• Chromatographic analyses (e.g., HPLC, CE, Process Residuals)
• ELISA/Immunoassay analyses
• Monosaccharide and Sialic Acid Analysis
• Amino Acid Composition and N-terminal Sequencing
• Utilize analytical software including Empower and Chromelion for data acquisition and interpretation.
• Analyze, evaluate, and integrate experimental data; prepare technical reports and regulatory-compliant documentation.
• Contribute to method development, qualification, validation, and transfer activities.
• Collaborate cross-functionally and interact directly with clients regarding project design, scheduling, and progress.
• Ensure all work meets cGMP, GLP, and safety standards.
• Assist in training junior staff, reviewing procedures, and improving SOPs and laboratory workflows.
• Participate in instrument qualification, calibration, and preventive maintenance programs.

Qualifications:

Education:

• Bachelor s degree in Chemistry, Biotechnology, or related scientific field required.
• M.S. or Ph.D. preferred.

Experience:

• Minimum 3+ years of relevant experience in a contract research, academic, or pharmaceutical environment.
• Hands-on experience in biotherapeutic characterization, analytical method development, and data interpretation.
• Working knowledge of cGMP and regulatory requirements in the pharmaceutical/biotech industry.

Technical Skills:

• Proficiency in HPLC, CE, Plate Reader, and spectrophotometry operations.
• Experience with LIMS and standard office applications (MS Word, Excel, Outlook).
• Strong analytical, documentation, and troubleshooting abilities.
• Excellent communication and collaboration skills.

Work Environment & Physical Requirements:

• Laboratory-based role; must adhere to safety and PPE protocols.
• Ability to remain stationary ~50% of the time and handle up to 50 lbs occasionally.
• Regular exposure to chemicals, biohazards, and laboratory equipment.
• May require overtime, weekend, or holiday coverage as needed.