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- 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
- Other duties as needed
- 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
- 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
- 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
- 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
- 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
- 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
Scientist I/II - Durham, United States - BioAgilytix
Description
Join our team as a Scientist I or II, leading the development and validation of Anti-drug Antibodies (ADA) and Pharmacokinetics (PK) assays, playing a vital role in bringing innovative therapies to market.
We're actively seeking candidates experienced in ELISA and MSD techniques to drive this mission forward.In this role, you'll thrive in a dynamic, milestone-driven environment, contributing to data generation and the evaluation of medicine performance within specific contexts.
Our commitment to data integrity and quality is unwavering, and you'll be instrumental in upholding these standards within a tightly regulated setting.
Essential Responsibilities:
Additional Responsibilities:
Minimum Preferred Qualifications - Education/Experience (Scientist I):
Minimum Preferred Qualifications - Education/Experience (Scientist II):
Minimum Preferred Qualifications - Skills:
Working Environment:
Physical Demands:
Position Type and Expected Hours of Work: