1035 O'Brien Drive
Industry: Clinical & Scientific
Job Number: 16304
Senior Coordinator/Project Manager, Assay Development
Our Assay Development team is looking to bring onboard a Senior Coordinator/Project Manager. This individual will support the Assay Development team through development and performance of Assay Development (AD) systems, policies, processes, and procedures to ensure that team activities are scheduled and coordinated within the team, with other functions, and with external contractors.
Core Duties and Responsibilities:
- Attends project team meetings and provides input on timeline feasibility, adjusts departmental, Analyst, and Assay timelines to meet changing needs, fosters communication with various stakeholders such as the Preclinical, Clinical, QC, and PD groups
- Attends teleconferences with CROs, keeps in-house minutes, checks on progress of action items from both parties; may participate in technical audits of CROs
- Works with group scientists to write and finalize SOWs, SOW revisions, MSAs, CDAs, and timelines for CROs
- Coordinates development of and training on departmental SOPs, STMs, work plans, and data reporting forms
- Tracks billing for services by outside vendors (CROs) and help Accounting reconcile invoices with work performed
- Responsible for monitoring continuous improvement of departmental processes and procedures.
- May assist in review and updating of Laboratory Notebooks.
- Oversees the duties of the Lab Coordinator in Sample Management
- Oversees preventative and routine maintenance, calibration, and vendor qualification of laboratory equipment and instrumentation as needed.
- Ensures sufficient inventory of materials, supplies and equipment in the laboratory for performance of duties.
Position Requirements and Experience:
- At least five years of biotechnology industry experience, preferably in an analytical testing laboratory.
- Project Management training is desired
- Supervisory experience preferred
- Experience with sample management
- Experience with database organization
- Experience with fast paced workflow involving independent teams
- Experience with oversight of CRO relations a plus
- Experience with Bioanalytical Assays is a plus