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Scientist (Gene and Cell Therapy)

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

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Sector
Science, Life Sciences, Cell and Molecular Biology
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 who need them.

The Scientist, Gene and Cell Therapy is responsible for bioanalytical method development, validation, and sample analysis for the extraction and quantitation of specific nucleic acids for CMC, preclinical and clinical studies supporting the pharmaceutical development of cell and gene therapies.

Essential Responsibilities
  • Perform bioanalytical method development, validation, and sample analysis for the extraction and quantitation of specific nucleic acids for CMC, preclinical and clinical studies supporting the pharmaceutical development of cellular and gene therapies, according to GxP principles
  • Supervise and train analysts and junior scientists and troubleshoot assays
  • Manage material, equipment and instrumentation
  • Identify, monitor and manage external providers for sourcing of molecular-biology specific reagents (e.g., oligonucleotides) and activities (e.g., plasmid production and linearization)
  • Order and keep accurate inventories of supplies for laboratory needs and forecast future needs based on projected needs
  • Analyze and interpret data, prepare summary tables and review raw data
  • Write SOPs, study plans and reports
  • Provide client satisfaction, quality and on-time delivery of BioAgilytix services
  • Communicate with clients, as needed
Additional Responsibilities
  • Other duties as needed
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 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
  • Scientist II:
  • Bachelor's degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than eight (8) years' experience in a scientific laboratory environment; or
  • Master'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
  • PhD in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than four (4) years' experience in a scientific laboratory environment
  • Scientist III:
  • 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
  • Not less than two (2) years' experience in GxP environments
Skills:
  • Expertise in molecular biology techniques and in analysis software
  • Proficiency in more than one of the following techniques: nucleic acid extraction, real-time PCR, digital droplet PCR, branched DNA assays, nanostring
  • Demonstrated ability to develop and validate robust nucleic acid extraction methods from multiple, complex biologic matrices
  • Demonstrated ability to develop and validate specific quantitative PCR assays to support CMC, preclinical and clinical development of cell and gene therapies
  • Demonstrated ability to analyze samples according to GxPs
  • Familiarity with automation and Laboratory Information Management (LIMs) systems
  • Experience working in GxP environments and/or demonstrated knowledge of GxP regulations
  • Knowledge of regulatory guidance and ability to apply them to experimental planning and design
  • Acute attention to detail and organizational skills
  • Ability to multi-task and to work well under time pressure
  • Ability to work effectively in a team to meet objectives under time constraints delivering the best quality
  • Experience serving in a supervisory role
  • Excellent oral and written communication skills
  • Fluency in English; with proficiency in additional languages preferred
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 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 and 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), 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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