Scientist I/II - ADA/PK

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, 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.

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 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

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.