Scientist I - ADA/PK

BioAgilytix; Durham (NC); On-site; USD 90,000 - 135,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

FSA

Paid Time Off

Parental Leave

401k Match

Referral Program

Job summary

BioAgilytix in Durham, NC is seeking a Scientist to lead the development and validation of ADA and PK assays, driving data generation and interpretation under GLP-regulated conditions. You will work on diverse drug modalities and present findings to clients, contributing to life-saving therapeutics.

The role requires ELISA and MSD experience, strong written and verbal communication, and the ability to train analysts while maintaining rigorous standards and deadlines in a fast-paced team.

Qualifications

• Bachelor/Master/PhD with lab experience in immunoassay platforms and GLP environments.
• Ability to develop immunoassays across multiple platforms with rigorous method validation.
• Strong written and verbal communication; experience guiding teams and projects.

Responsibilities

• Lead assay development projects for ADA and PK assays.
• Validate assays and present data to clients.
• Write plans and reports for validation and sample analysis.
• Manage project timelines, budgets, and client communications.
• Train analysts and supervise junior scientists.

Skills

Immunoassay development

Team leadership

GxP regulatory knowledge

PK/biomarker/ADA assays

Education

Bachelor’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field

Master’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field

PhD in molecular biology, biochemistry, immunology, biotechnology, or related field

Tools

ELISA

MSD-ECL

LIMS

MS Excel

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 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 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 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 - 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
• 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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