Summary

Designs, conducts, and interprets biological experiments to support development programs and identifies biological pathways and agents. Provides biological scientific support to technology and product development. Reviews scientific and technical summaries and provides recommendations for potential business applications.
 
Duties & Responsibilities:

• Performs detailed environmental monitoring, lab assays, and biomarker identification and development.
• Utilizes state-of-the-art knowledge to perform tasks efficiently.
• Performs biological indicator, growth promotion, endotoxin, and bioburden testing, as well as microbial identifications.
• Summarizes and conducts preliminary data interpretation, maintains accurate documentation, and ensures timely reporting.
• Provides scientific input based on current literature, and assists in writing abstracts and manuscripts.
• Utilizes computer software packages for data entry, literature searches, and data analysis.
• Operates and maintains laboratory equipment, including analytical and other instruments considered standard for area of expertise.
• Prepares standards, reagents, and controls according to established procedures.
• Works in an aseptic environment to ensure sterility and product safety in all biological testing and assays.

Requirements:

• Bachelor's or Master's degree in Biology, Microbiology, Biotechnology, or a related scientific discipline.
• Generally requires 2-4 years of work experience in biological testing or parenteral product development, preferably within a pharmaceutical or biotech environment.
• At least 1 year of experience working in an aseptic environment, performing sterile techniques and ensuring product integrity.
• Experience performing biological assays, including biomarker identification, growth promotion, endotoxin testing, bioburden testing, and microbial identification.
• Strong understanding and experience in the parenteral area, including the testing and validation of parenteral drug products, sterility and endotoxin testing, and quality control for injectable formulations.
• Familiarity with biological indicators and standard laboratory techniques in microbiology.
• Proven ability to operate and maintain laboratory equipment and analytical instruments related to biological testing.
• Experience using laboratory software for data entry and literature searches (e.g., LIMS, ELNs).
• Hands-on experience with environmental monitoring and biological testing procedures in a laboratory setting.
• Experience working with parenteral products, including sterility testing, container closure integrity testing, and quality assurance in the production and testing of injectable or parenteral drugs.