Essential Responsibilities:
- Serve as lead scientist on assay development project
- Serve as lead scientist on validation
- Present data to clients
- Independently write plans and reports for validation
- Responsible for prompt identification and notification of deviations
- Perform assays according to GLP guidelines
- Follow GLP guidelines for validation of assays
- Run assays independently
- Prepare worksheets independently
- Analyze and interpret data
- Prepare summary tables
- Peer review raw data
- Prepare buffers
- Troubleshoot assays
- Design assay runs independently
- Write SOPs
- Write plans/reports for sample analysis
- Order and keep accurate inventories of supplies for laboratory needs and forecast future needs based on projected project needs
- May serve as principal investigator on a project
- May prepare and submit deviations
- Manage project timelines/scheduling
- Manage budget and revenue for projects
- Communicate with client
- Train analysts/junior scientists
- Develop assay independently
- Ability to assist with definition of project scope and proposal preparation (SME)
- Prepare and review scientific training materials
- Set up studies in LIMS system
- Other duties, as assigned
Additional Responsibilities:
- Other duties as needed
Minimum Preferred Qualifications - Education/Experience (Scientist I):
- Bachelor’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than six (6) years’ experience in a scientific laboratory environment; or
- Master’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than four (4) years’ experience in a scientific laboratory environment; or
- PhD in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than 2 years’ experience in a scientific laboratory environment
Minimum Preferred Qualifications - Skills:
- Ability to develop immunoassays in some or all of the following immunoassay platforms: ELISA, MSD-ECL, RIA, DELFIA, HTRF, and AlphaScreen
- Ability to carry out routine tasks accurately, following strict methodology to carry out analysis, preparing samples and maintaining and operating standard laboratory equipment
- 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
- IA role: Experience with execution of PK/biomarker/ADA assays
- CB role: Experience with execution of potency/NAb assays
Working Environment:
- Primarily 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 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 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
Position Type and Expected Hours of Work:
- This is a full-time position
- Some flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook
- Occasional weekend, holiday, and evening work required
- Occasional travel required