Principal Investigator

Essential Responsibilities

• Develop and validate biomarker, cell-based, immunogenicity, immuno- and enzymatic assays for support of preclinical, clinical and product release studies
• Work closely with clients to assure successful on time execution of assays, validation and sample analysis under GxPs
• Design and execute experiments efficiently
• Conduct routine analysis
• Present data and posters
• Perform statistical analysis
• Write reports and prepare SOPs
• May fulfill the role of Bioanalytical Project Manager
• Other duties as needed

Minimum Acceptable Qualifications

Education/Experience:

• Bachelor's degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than ten (10) years' experience in a scientific laboratory environment; or
• Master's degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than eight (8) years' experience in a scientific laboratory environment; or
• PhD in molecular biology, biochemistry, immunology, biotechnology, or related field not less than six (6) years' experience in a scientific laboratory environment

Skills:

• Ability to develop immunoassays in some or all of the following immunoassay platforms: ELISA, MSD-ECL, RIA, DELFIA, HTRF, and AlphaScreen
• Must work effectively within team to meet objectives under time constraints
• Ability to take direction well and multi-task
• Detail oriented and highly organized
• Excellent oral and written communication skills
• Proficient in the use of MS Excel and Word
• Demonstrated experience serving in a supervisor role and leading teams
• Knowledge and application of regulatory guidance to experimental planning and design
• Experience working in GxP environments and demonstrated knowledge of GxP regulations

Working Environment

• Primarily office environment
• Occasional laboratory environment
• Exposure to biological fluids with potential exposure to infectious organisms
• Rare exposure to skin and lung irritants, toxic materials, and hazardous waste
• Personal protective equipment required, such as protective eyewear, garments, and gloves
• Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets

Physical Demands

• Ability to work in an upright and/or stationary position for up to eight (8) hours per day
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab and office equipment
• Frequent mobility needed
• Frequent crouching, stooping, with frequent bending and twisting of upper body and neck
• Light to moderate lifting and carrying (or otherwise moves) objects including office supplies, laboratory equipment, laboratory supplies, and laptop computer with a maximum lift of 20 pounds
• Ability to access and use a variety of computer software
• Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
• Frequently interacts with others to obtain or relate information to diverse groups
• Requires multiple periods of intense concentration
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
• Ability to perform under stress and multi-task
• Regular and consistent attendance