SUMMARY
The Research and Development Specialist is responsible for the design, development and validation of analytical procedures, including the study management of method development, validation and investigational studies, ensuring effective implementation.
RESPONSIBILITIES
- Develop validation plans, validation summary reports, stability summary reports, correlation plans and correlation summary reports to meet regulatory requirements.
- Provide supporting information to Scientific Affairs in the evaluation of appropriate testing and/or methodology.
- Liaise with technical staff on feasibility of testing for new study requirements.
- Provide pricing as needed to the Proposals team.
- Select appropriate test methods; research and identify suppliers of laboratory consumables and equipment options for new tests to support clinical trial opportunities.
- Facilitate assay development, conduct instrument validations and implement new testing to satisfy the needs of clinical trials protocols, clients and regulatory requirements.
- Be responsible for assay/panel pre‑validation and validation and correlation testing worldwide.
- Ensure all methods and validations comply with applicable regulatory guidelines, including GCP, GLP, GCLP and CAP.
- Investigate and take corrective action for assay troubleshooting and proficiency testing failures.
- Assess the impact of manufacturer/vendor communications and complete associated documentation.
- Provide study management and direction of laboratory teams for the implementation of analytical method validations.
- Offer consultation and technical support to clinical trials clients and operational staff.
- Manage communications (meetings, calls, audits, etc.) with clients and formulate required responses.
- Prepare SOPs for newly developed test procedures and relevant documentation as necessary.
- Document and own any quality documentation (Note to File, Quality Event, CAPA, deviation, change control) within required time frames.
- Participate in activities ensuring compliance with GCP guidelines and accreditation schemes (e.g., CAP).
- Prepare documentation for and participate in internal and external audits (client and regulatory).
- Comply with policies for the safe, secure and confidential processing and storage of patient/client data and other laboratory information.
REQUIRED EXPERIENCES
- BSc (or equivalent) or higher in a relevant scientific subject.
- Minimum of 4 years’ experience within a laboratory environment.
- Proven experience with external client interactions and managing deliverables from a laboratory, scientific, or technical standpoint.
- Demonstrable experience managing validation activities within a laboratory setting (clinical laboratory experience highly preferred).
- Strong analytical, problem‑solving and communication skills.
- Highly organized with the ability to manage multiple projects simultaneously.
- Ability to interpret complex technical information and translate findings into clear recommendations.
PHYSICAL REQUIREMENTS
Work is sedentary, with occasional walking or standing. Exerting up to 10 pounds of force occasionally. Work involves sitting most of the time, but may include brief periods of walking or standing.
LEGAL DISCLOSURES AND RELATIONSHIP
Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.
At ACM Global Laboratories, we understand that every project we work on, every task we complete impacts patients and their families. Our dedication to being purposefully patient‑driven is reflected in the high‑quality work provided by our teams every day around the globe.
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