Scientist III - 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. \n Essential Responsibilities Serve as Bioanalytical Project Manager on a project (BPM)/Principal investigator (PI) May prepare and submit deviations Manage project timelines/scheduling Manage budget and revenue for projects Communicate with client Train analysts/junior scientists Develop assays independently Ability to assist with definition of project scope and proposal preparation (SME) Prepare and review scientific training materials (e.g. BAL University) Set up studies in LIMS system Serve as lead scientist on assay dev 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 & interpret data Write SOPs and plans/reports for sample analysis Order and keep accurate inventories of supplies for laboratory needs and forecast future needs based on projected project needs

Minimum Acceptable Qualifications:

Education/Experience Bachelor's degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than 12 years' experience in a scientific laboratory environment; or Master's degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than ten (10) years' experience in a scientific laboratory environment; or PhD in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than eight (8) years' experience in a scientific laboratory environment

Minimum Acceptable Qualifications:

Skills Ability to develop immunoassays in some or all of the following platforms: ELISA, MSD-ECL, RIA, DELFIA, HTRF, and AlphaScreen Experience in AAV/gene therapy (preferred) Work effectively within team to meet objectives under time constraints Ability to perform under stress 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 Preferred experience working in GxP environments and demonstrated knowledge of GxP regulations Ability to use a variety of computer software Working Environment Primarily GLP regulated laboratory environment 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 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 \n

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.