Beken Bio, Inc.
Director of Laboratory Operations
Beken Bio, Inc., New Orleans, Louisiana, United States, 70123
Overview
Beken Bio is a biotechnology startup on a mission to revolutionize early cancer detection. Our flagship program focuses on a novel liquid biopsy test for ovarian cancer using extracellular vesicles (EVs). As we move our diagnostic test from R&D into the critical validation and commercialization phase, we are building a nimble, high-impact team to make precision oncology accessible to patients. Responsibilities
Lead the technical operations of the laboratory during the critical transition from R&D to clinical validation of a new diagnostic assay. Supervise and mentor laboratory testing personnel, ensuring competency, adherence to CLIA regulations, and high-quality results. Implement and maintain laboratory procedures, quality control, and quality assurance protocols. Oversee the validation, verification, and documentation of new laboratory-developed tests in compliance with CLIA and state regulations. Collaborate with the Laboratory Director and R&D team to optimize protocols, streamline workflows, and troubleshoot assay development challenges. Contribute to regulatory readiness, including preparation for inspections and audits. Participate in strategic planning for laboratory expansion, automation, and scale-up as the company grows. Wear multiple hats: participate in hands-on bench work, process design, and operational planning as needed. Qualifications
Education:
Bachelor’s degree (or higher) in a laboratory science (Clinical Laboratory Science, Microbiology, Biochemistry, Molecular Biology, or related field). Experience:
Minimum 1 year of experience in a high-complexity clinical laboratory setting. Experience:
Demonstrated experience supervising lab staff and implementing laboratory procedures. Experience:
Experience with assay validation, clinical testing, or LDT development is highly desirable. Certifications:
Certified Clinical Laboratory Scientist (CLS/MLS) through a recognized body (ASCP, AMT, or equivalent). Certifications:
Louisiana State Licensure (or eligibility to obtain) Skills:
Strong understanding of CLIA regulations and quality management systems. Skills:
Excellent problem-solving, organizational, and communication skills. Skills:
Comfort working in a dynamic startup environment, wearing multiple hats, and contributing across operational, technical, and strategic aspects. Preferred Qualifications
Master’s degree in a laboratory or molecular diagnostics field. Experience transitioning assays from R&D to clinical use, including clinical validation studies. Familiarity with molecular diagnostics, oncology testing, and lab automation. Seniority level
Director Employment type
Full-time Job function
Research, Analyst, and Information Technology Referrals increase your chances of interviewing at Beken Bio by 2x Get notified about new Director Laboratory Operations jobs in
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Beken Bio is a biotechnology startup on a mission to revolutionize early cancer detection. Our flagship program focuses on a novel liquid biopsy test for ovarian cancer using extracellular vesicles (EVs). As we move our diagnostic test from R&D into the critical validation and commercialization phase, we are building a nimble, high-impact team to make precision oncology accessible to patients. Responsibilities
Lead the technical operations of the laboratory during the critical transition from R&D to clinical validation of a new diagnostic assay. Supervise and mentor laboratory testing personnel, ensuring competency, adherence to CLIA regulations, and high-quality results. Implement and maintain laboratory procedures, quality control, and quality assurance protocols. Oversee the validation, verification, and documentation of new laboratory-developed tests in compliance with CLIA and state regulations. Collaborate with the Laboratory Director and R&D team to optimize protocols, streamline workflows, and troubleshoot assay development challenges. Contribute to regulatory readiness, including preparation for inspections and audits. Participate in strategic planning for laboratory expansion, automation, and scale-up as the company grows. Wear multiple hats: participate in hands-on bench work, process design, and operational planning as needed. Qualifications
Education:
Bachelor’s degree (or higher) in a laboratory science (Clinical Laboratory Science, Microbiology, Biochemistry, Molecular Biology, or related field). Experience:
Minimum 1 year of experience in a high-complexity clinical laboratory setting. Experience:
Demonstrated experience supervising lab staff and implementing laboratory procedures. Experience:
Experience with assay validation, clinical testing, or LDT development is highly desirable. Certifications:
Certified Clinical Laboratory Scientist (CLS/MLS) through a recognized body (ASCP, AMT, or equivalent). Certifications:
Louisiana State Licensure (or eligibility to obtain) Skills:
Strong understanding of CLIA regulations and quality management systems. Skills:
Excellent problem-solving, organizational, and communication skills. Skills:
Comfort working in a dynamic startup environment, wearing multiple hats, and contributing across operational, technical, and strategic aspects. Preferred Qualifications
Master’s degree in a laboratory or molecular diagnostics field. Experience transitioning assays from R&D to clinical use, including clinical validation studies. Familiarity with molecular diagnostics, oncology testing, and lab automation. Seniority level
Director Employment type
Full-time Job function
Research, Analyst, and Information Technology Referrals increase your chances of interviewing at Beken Bio by 2x Get notified about new Director Laboratory Operations jobs in
New Orleans, LA . We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr