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Scientist (CMC/GMP)

Employer
BioAgilytix Labs
Location
Durham County, NC
Closing date
May 15, 2022

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Sector
Science
Organization Type
Corporate
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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 that need them. Essential Responsibilities • Serves as lead scientist on assay development, validation, and sample analysis project for support of CMC characterization, stability and release testing • Follows GMP guidelines for method validation and sample analysis • Independently writes plans and reports for validation and sample analysis • Responsible for prompt identification, submission, notification, and review of deviations • Designs and runs assay run independently • Analyzes, interprets, and summarizes data • Troubleshoots assays • Writes standard operating procedures (SOPs) • Orders and keeps accurate inventories of supplies for laboratory needs and forecast future needs based on projected project needs • Manages project timelines and scheduling • Manages budget and revenue for projects • Communicates with client, including but not limited to presenting data, updating timeline, and notifying of issues • Prepares and reviews scientific training materials • Trains analysts/junior scientists • Assists with definition of project scope and proposal preparation; serves as subject matter expert (SME) • Other duties as assigned Minimum Acceptable Qualifications Education/Experience: The education and experience requirements for a Scientist I, II, and III are as follows: • Scientist I: Bachelor's degree in laboratory-based sciences, including chemistry, pharmaceutical science, molecular biology, biochemistry, immunology, biotechnology, or related field and not less than six (6) years' related laboratory experience within an industry lab; or Master's degree in laboratory-based sciences, including chemistry, pharmaceutical science, molecular biology, biochemistry, immunology, biotechnology, or related field and not less than four (4) years' related laboratory experience within an industry lab; or PhD in laboratory-based sciences, including chemistry, pharmaceutical science, molecular biology, biochemistry, immunology, biotechnology, or related field with not less than two (2) years' related laboratory experience within an academic or industry lab • Scientist II: Bachelor's degree in laboratory-based sciences, including chemistry, pharmaceutical science, molecular biology, biochemistry, immunology, biotechnology, or related field and not less than eight (8) years' related laboratory experience within an industry lab; or Master's degree in laboratory-based sciences, including chemistry, pharmaceutical science, molecular biology, biochemistry, immunology, biotechnology, or related field and not less than six (6) years' related laboratory experience within an industry lab; or PhD in laboratory-based sciences, including chemistry, pharmaceutical science, molecular biology, biochemistry, immunology, biotechnology, or related field with not less than four (4) years' related laboratory experience within an academic or industry lab • Scientist III: Bachelor's degree in laboratory-based sciences, including chemistry, pharmaceutical science, molecular biology, biochemistry, immunology, biotechnology, or related field and not less than 12 years' related laboratory experience within an industry lab; or Master's degree in laboratory-based sciences, including chemistry, pharmaceutical science, molecular biology, biochemistry, immunology, biotechnology, or related field and not less than ten (10) years' related laboratory experience within an industry lab; or PhD in laboratory-based sciences, including chemistry, pharmaceutical science, molecular biology, biochemistry, immunology, biotechnology, or related field and not less than six (6) years' related laboratory experience within an industry lab Skills: • Ability to develop analytical assays in all or some the following platforms for biomolecule analysis: High Performance Liquid Chromatography (HPLC)/ Ultra Performance Liquid Chromatography (UPLC); capillary electrophoresis (CE); Liquid chromatography-mass spectrometry (LC-MS); dynamic light scattering (DLS); analytical ultracentrifugation (AUC); ddPCR/qPCR/RT-qPCR; protein/DNA sequencing; western blot; flow cytometry; cell-based assays; enzyme-linked immunoassay (ELISA); and Meso Scale Discovery Electrochemiluminescence (MSD-ECL) • Demonstrated experience in cell culture, transduction, transfection, DNA and protein sequencing • Ability to 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 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) • Paid Holidays (9 scheduled; 3 floating) • 401k with Employer Match • Employee Referral Program (up to $10k) • Free Coffee, Tea, Fruit, and Snacks • Discounted Vending Machines (25 cents for everything!) • Team Wellness Challenges/Events 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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