As a part of Clinical Trials Scientific Affairs, the Senior Principal Scientist will lead method selection, development, validation, and implementation. The Senior Principal Scientist is required to keep up to date with new methods, applications and regulation while providing technical support at the bench, method validation and/or method improvement. The Senior Principal Scientist will report to the Vice President of Clinical Lab Operations.
RESPONSIBILITIES
Oversee the development, validation, and implementation of new tests and procedures to ensure the clinical laboratory meets the needs of all clients.
Ensure appropriate technical methods are utilized. Works with the Laboratory Director to develop protocols and oversee laboratory instrument selection, evaluation, validation and implementation.
Mentor staff on scientific and regulatory aspects of testing to ensure esoteric test understanding.
Review client protocols, prepare proposals and quotations to assist the business development team. Advise as necessary.
Assist the Laboratory Director in the selection of new instrumentation globally.
Provide advice on methodology, instrumentation and costs for new assays
Act as a subject matter expert for Clinical Trials Analysts, Business Development and ACM clients.
Draft client communications regarding testing issues or changes.
Provide scientific, technical and regulatory support on interpretation of laboratory data as required.
Perform result trending for studies following endpoints.
Technical writing and/or scientific review of Bioanalytical reports for clients as applicable.
Mentor R&D staff on bioanalytical study management and report writing.
Prepare scientific data, including sample stability, method information, reference ranges, etc. to support test menu development.
Partner with the Laboratory Director to provide test catalog oversight, review and approvals for changes.
In conjunction with laboratory management and Laboratory Director, periodically review laboratory and quality control/assessment data to ensure accurate and precise results are continually produced, and participate in the ACM Global inter-laboratory correlation and standardization process.
Oversee the training of staff in new techniques as necessary.
Participate in continuous professional improvement and maintain knowledge of industry trends to assist in building new capabilities/service lines
Write and review Standard Operating Procedures (SOPs) and relevant documentation as necessary.
May participate in internal/external client and regulatory audits.
Promote and support a culture of regulatory compliance and audit-readiness within ACM Global Laboratories
Ensure all methods and validations are done according to all applicable regulatory standards and guidelines, including but not limited to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), College of American Pathologists (CAP), UK Medicines and Healthcare Products Regulatory Agency (MHRA), US Food and Drug Administration (FDA), International Organization for Standardization (ISO), etc.
REQUIRED QUALIFICATIONS
Ph.D. in Biomedical Sciences, such as Chemistry, Biology, Immunology, etc. required
8 years of experience in a regulated analytical testing environment required (GCP/GLP).
PREFERRED QUALIFICATIONS
Active experience working within a Central Laboratory environment, in particular in clinical chemistry and/or hematology departments - 2 years should be within a laboratory specialty
2 years of laboratory supervision experience preferred
Experience in Good Clinical Practice (GCP) required
Experience in Good Laboratory Practice (GLP) desirable
Experience with College of American Pathology (CAP), UK Medicines & Healthcare products Regulatory Agency (MHRA), and/or US Food & Drug Administration (FDA) preferred
Experience in quality improvement implementation preferred
US ONLY: Eligibility to obtain NYS Certification of Qualification in Clinical Chemistry, Diagnostic Immunology, Endocrinology, and/or Hematology preferred.
US ONLY: Board Certification in one of the following areas preferred:
ABB - American Board of Bioanalysis
ABCC - American Board of Clinical Chemistry
ABFT - American Board of Forensic Toxicology (limited to individuals with a doctoral degree)
ABHI - American Board of Histocompatibility and Immunogenetics
ABMGG - American Board of Medical Genetics and Genomics (formerly known as American Board of Medical Genetics (ABMG))
ABMLI - American Board of Medical Laboratory Immunology
ABMM - American Board of Medical Microbiology
NRCC - National Registry of Certified Chemists (limited to individuals with a doctoral degree)
EDUCATION:
PhD (Required)
PHYSICAL REQUIREMENTS: M - Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects; Requires frequent walking, standing or squatting.
PAY RANGE: $100,000.00 - $130,000.00
The listed base pay range is a good faith representation of current potential base pay for successful applicants. It may be modified in the future. Pay is determined by factors including experience, relevant qualifications, specialty, internal equity, location, and contracts.
Rochester Regional Health is an Equal Opportunity / Affirmative Action Employer. Minority/Female/Disability/Veteran
