Scientist II - ADA/PK

Essential Responsibilities:

Serve as lead scientist on assay development projects
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 II):

Bachelor’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
Master’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
PhD in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than four (4) years’ experience in a scientific laboratory environment
 

Demonstrated hands-on experience with the Gyrolab platform
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  
Experience with execution of PK/biomarker/ADA 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