Scientist II - ADA/PK

BioAgilytix; Durham (NC); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401k with Employer Match

Paid Time Off

Job summary

BioAgilytix in Durham, NC seeks a Scientist II to lead the development and validation of Anti-drug Antibody (ADA) and PK assays that support drug development. The role emphasizes hands‑on Gyrolab work, immunoassay development, and adherence to GLP/GxP in a regulated lab.

The successful candidate will drive assay development, data generation, and client communication while mentoring analysts and ensuring data integrity within milestone-driven timelines.

Qualifications

• Bachelor’s degree with not less than eight (8) years’ experience in a scientific laboratory environment; or
• Master’s degree with not less than six (6) years’ experience; or
• PhD with not less than four (4) years’ experience in a scientific laboratory environment.
• Hands‑on Gyrolab platform experience.
• Develop immunoassays across ELISA, MSD‑ECL, RIA, DELFIA, HTRF, AlphaScreen.
• Supervise and lead teams; strong regulatory guidance awareness.
• Experience in GxP environments and PK/biomarker/ADA assays.

Responsibilities

• Lead assay development projects.
• Lead validation activities.
• Present data to clients.
• Write validation plans and reports.
• Follow GLP guidelines for assays and validation.
• Run assays and prepare worksheets.
• Analyze and interpret data; prepare summary tables.
• Peer review raw data and troubleshoot assays.
• Train analysts and junior scientists.

Skills

Gyrolab platform experience

Immunoassay development

Supervisor / leadership

GxP / GLP knowledge

PK/biomarker/ADA assays

MS Excel & Word

Education

Bachelor’s degree with 8+ years experience

Master’s degree with 6+ years experience

PhD with 4+ years experience

Tools

MS Excel

LIMS system

Job description

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 Antibody (ADA) and Pharmacokinetic (PK) assays that play a vital role in bringing innovative therapies to market. We're seeking candidates with demonstrated hands‑on experience using the Gyrolab platform, along with experience performing ELISA and/or MSD assays in a regulated bioanalytical laboratory. In this role, you'll thrive in a dynamic, milestone‑driven environment, contributing to assay development, data generation, and the evaluation of therapeutic performance. Our commitment to data integrity and quality is unwavering, and you'll play an instrumental role in upholding these standards within a highly regulated setting.

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

Additional Qualifications

• 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

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.

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