Senior Principal Scientist
The Senior Principal Scientist will report to the Director of Scientific Affairs, and will be responsible for management and execution of analytical technical activities and ensure their quality for ACM Clinical Laboratory, Inc. Responsibilities will include development of comprehensive policies and procedures for test and analyzer evaluation, development, validation and implementation. This position will work closely with the Scientific Affairs, Proposals and Business Development to ensure ACM Global Laboratories’ can provide high quality clinical insights to our clients, impacting patients around the world.
STATUS: Full Time
LOCATION: ACM Global Laboratories - Headquarters (160 Elmgrove Park, Rochester, NY)
DEPARTMENT: Clinical Trials
SCHEDULE: Monday - Friday, Days
- PhD in Biomedical Sciences, such as, Chemistry, Biology, Immunology, etc. required.
- 10 years of experience in a laboratory environment required.
- 4 years of experience in a clinical laboratory preferred.
- 2 years of laboratory supervision experience preferred.
- Experience in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and/or Good Clinical Laboratory Practice (GCLP) preferred.
- Experience with College of American Pathology (CAP), Medicines & Healthcare products Regulatory Agency (MHRA), and/or Food & Drug Administration (FDA) preferred.
- Eligibility to obtain NYS Certification of Qualification in Clinical Chemistry, Diagnostic Immunology, Endocrinology, and/or Hematology preferred.
- 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)
- Method & Test Development. Oversee the development, validation, and implementation of new tests and procedures to ensure the clinical laboratory meets the needs of all clients, especially non-FDA approved assays to support Clinical Trial clients. Ensure appropriate technical methods are utilized. Develop protocols and oversee laboratory instrument selection, evaluation, validation and implementation. Advise on selection of new instrumentation globally. Prepare scientific data, including sample stability, method information, reference ranges, etc. to support test menu development. Participate in Continuous Professional Development and any other activity needed to ensure continuing registration as a Clinical Scientist or Laboratory Director, and keep abreast of new developments in the Biomedical Sciences and Clinical specialty and advise on new initiatives as appropriate.
- Quality. Provide scientific and technical support on interpretation of laboratory data as required. Establishing and signing off acceptance of reference ranges. Review and approve validation studies of each test for clinical use. In conjunction with the laboratory manager, 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. Supervise the training of staff in new techniques as necessary. Work with the QA department in writing and reviewing Standard Operating Procedures and relevant documentation as necessary. Participation in all activities that seek to ensure compliance with GCP guidelines and CAP accreditation. Comply with policies for the safe, secure and confidential processing and storage of patient and other laboratory information.
- Client Relations. Review client protocols and prepare proposals and quotations to assist the business development team. Advise as necessary. Liaise with Proposals and Business Development and the VP of clinical operations to advice on methodology, instrumentation and costs for new assays to be introduced into the laboratory to assist in the development of quotations. Provide test analytical information and participate in conference calls and meetings with clinical trials analysts, business development and ACM clients.