Beken Bio
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.
Position Overview We are seeking a
General Supervisor
with a blend of technical expertise, leadership experience, and entrepreneurial spirit. This is a hands‑on, multifaceted role in a dynamic startup environment where you will oversee the transition of a diagnostic test from research into a fully validated, CLIA‑certified laboratory‑developed test (LDT). The right candidate will embrace the challenge of helping to shape laboratory operations, oversee clinical validation, and contribute to building scalable processes in a fast‑moving, innovative company.
Key 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.
Required 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
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Position Overview We are seeking a
General Supervisor
with a blend of technical expertise, leadership experience, and entrepreneurial spirit. This is a hands‑on, multifaceted role in a dynamic startup environment where you will oversee the transition of a diagnostic test from research into a fully validated, CLIA‑certified laboratory‑developed test (LDT). The right candidate will embrace the challenge of helping to shape laboratory operations, oversee clinical validation, and contribute to building scalable processes in a fast‑moving, innovative company.
Key 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.
Required 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
#J-18808-Ljbffr