Scientist I/II - ADA/PK Durham, NC Lab Operations /FT /On-site
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At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.
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:
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 - 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
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
BENEFITS AND OTHER PERKS
Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (9 scheduled; 5 floating), 401k with Employer Match, Employee Referral Program
COMMITMENT TO EQUAL OPPORTUNITY
BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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