Principal Investigator (CMC/GMP)

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.

• Serve as lead scientist on assay development, validation, and sample analysis project
• Follow GMP guidelines for validation of assays and sample analysis
• Independently write plans and reports for validation and sample analysis
• Responsible for prompt identification, submission, notification, and review of deviations
• Design and run assay run independently
• Analyze, interpret, and summarize data
• Troubleshoot assays
• Write SOPs
• Order and keep accurate inventories of supplies for laboratory needs and forecast future needs based on projected project needs
• Manage project timelines/scheduling
• Manage budget and revenue for projects
• Communicate with client, including presenting data, updating timeline, and notifying issues
• Prepare and review scientific training materials
• Train analysts/junior scientists
• Assist with definition of project scope and proposal preparation (SME)
• Other duties, as assigned

• Bachelor’s degree in laboratory-based sciences, including chemistry, pharmaceutical science, 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 laboratory-based sciences, including chemistry, pharmaceutical science, molecular biology, biochemistry, immunology, biotechnology, or related field with not less than ten (10) years’ experience in a scientific laboratory environment; or
• PhD in laboratory-based sciences, including chemistry, pharmaceutical science, molecular biology, biochemistry, immunology, biotechnology, or related field with not less than eight (8) years’ experience in a scientific laboratory environment

• Ability to develop analytical assays in some or all of the following platforms for biomolecule analysis: HPLC/UPLC, CE, LC-MS, DLS, AUC, ddPCR/qPCR/RT-qPCR, Protein/DNA sequencing, Western Blot, flow cytometry, Cell-based Assay, ELISA, and MSD-ECL
• Experience in cell culture, transduction, transfection, DNA and protein sequencing
• 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 GMP environments and demonstrated knowledge of GMP regulations
• Ability to use a variety of computer software
• Previous GMP/QC Lab experiences preferred

• Primarily GMP 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

• 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
• 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.