Job Description
The Associate Scientist/Scientist – Biologic Analytical Development is responsible for the development and qualification of assays for biologic products.
Duties and Responsibilities

• Participate assay development and optimization for ELISA, flow cytometry, bioassay, PCR and CE for biologic materials.
• Prepare methods for the transition to a GMP QC environment
• Author method procedures and SOPs
• Maintain sample and data integrity at all times
• Use sophisticated laboratory instrumentation and computer systems to collect and record data.
• Perform equipment maintenance and calibrations as required.
• Maintain lab readiness for audits by both internal and external authorities.
• Execute qualification/validation of analytical methods per ICH & USP guidelines
• Required to work in the laboratory that has a certain level of noise and contains hazardous chemicals

Qualifications:

• BS or MS in a science related field, including but not limited to Chemistry, Pharmacology, food science, Chemical Engineering, Biology and Healthcare.
• 4-6 years of experience in a biologics laboratory with a BS or Master’s Degree and 2-4 years of related experience or Ph.D. and 2 years of related experience
• Knowledge of most laboratory equipment including but not limited to plate readers, cytometer, PCR & CE
• Experience in developing assays for a biological product
• Written communication skills require full competence in following detailed written instructions, creating/revising SOPs, protocols and reports
• Knowledge of chemical and biological safety procedures/precautions
• Proficient in Microsoft Office – Outlook, Word, Excel, Powerpoint