The Research & Development Specialist will be responsible for execution of analytical technical activities and ensure their quality for ACM Global Laboratories. Responsibilities will include development of comprehensive policies and procedures for test development, method validation and implementation.

STATUS: Full Time

LOCATION: Rochester, NY - Elmgrove

DEPARTMENT: Clinical Trials

SCHEDULE: Days

ATTRIBUTES

• BS degree in life science field required
• Minimum of 3 years laboratory experience required
• Medical Laboratory Technology license preferred
• Experience with EP evaluator preferred

RESPONSIBILITIES

• Validation. Facilitate assay development, conduct instrument validations and implement new testing to meets the needs of all clients, including FDA and non-FDA approved assays to support Clinical Trial clients. Develop validation plans, validation summary reports, stability study summary reports, correlation plans and correlation summary reports to meet regulatory requirements. Responsible for the identification, collection and preparation of specimens for validations, correlation and stability studies. Train staff to perform newly validated techniques and assays.
• Quality & Compliance. Prepare standard operating procedures for newly developed test procedures and relevant documentation as necessary. Comply with policies for the safe, secure and confidential processing and storage of patient and other laboratory information.
• Scientific Affairs. Research / identify suppliers of laboratory consumables and equipment options for new tests to support clinical trials opportunities. Perform laboratory testing using various laboratory techniques as necessary. Prepare scientific data, including sample stability, method information, reference ranges, etc. to support Scientific Affairs. Participate on teleconference calls with clients and formulate written responses to clients effectively as needed.