Scientist III - ADA/PK

BioAgilytix • Durham, NC

7d • Onsite

About The Position

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.

Requirements

• 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
• Ability to develop immunoassays in some or all of the following platforms: ELISA, MSD-ECL, RIA, DELFIA, HTRF, and AlphaScreen
• 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

Nice To Haves

• Experience in AAV/gene therapy (preferred)
• Preferred experience working in GxP environments and demonstrated knowledge of GxP regulations

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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees