Demo

Scientist I - Cell & Gene Therapy

BioAgilytix
Durham, NC Full Time
POSTED ON 1/24/2025
AVAILABLE BEFORE 3/24/2025

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.


Become a key contributor to our team as a Scientist I, supporting the development and validation of PCR assays that are instrumental in bringing innovative cell and gene therapies to market. We are actively seeking candidates with exposure to ddPCR and qPCR techniques with the ability to perform assays independently in a CRO/CDMO environment. In this dynamic role, you will thrive in a milestone-driven environment, actively contributing to data generation while providing scientific input.



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As a Scientist I, your day-to-day activities will include:
  • Run PCR assays independently with a primary focus on ddPCR and qPCR
  • 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
  • Prepare worksheets independently
  • Analyze & interpret data
  • Prepare summary tables
  • Peer review raw data
  • Prepare buffers
  • Troubleshoot assays
  • Design assay runs independently
  • Responsible for prompt identification and notification of deviations
  • Write SOPs
  • Write plans/reports for sample analysis
  • Order and keep accurate inventories of supplies for laboratory needs and forecast future needs based on projected project needs
  • Perform assays according to GxP guidelines
  • Follow GxP guidelines for validation of assays


These are skills needed to be successful:
  • 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
  • A knack for designing efficient and impactful experiments
  • Experience or familiarity working in a regulated environment, with a thorough understanding of Good Documentation Practices
  • Independence, enthusiasm, openness and adaptability
  • Effective communication skills
  • Motivation and an ability to inspire others to do their best work and drive results
  • Excellent customer service skills (internal and external)


Minimum Preferred Qualifications - Education/Experience (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


The benefits of joining our team:
  • Broad exposure to a wide variety of protein therapeutics (enzymes, gene & cell therapy, multifunctional therapeutic, oncolytic virus)
  • Access to a network of expert bioanalytical scientists to collaborate with and grow
  • Continued development and growth, international sites exposure and contacts
  • Exposure to cutting-edge bioanalytical technologies
  • Highly competitive healthcare coverage (HDHP with HSA; PPO), dental and vision
  • Competitive Paid Time Off (4 weeks per year) Paid Holidays (9 scheduled; 5 floating)
  • 401k with Employer Match


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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.

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