Robin Blake Email & Phone Number

Holliston, Ma, Us

Massachusetts, United States

 Aligns the Tissue Procurement operation activities with company’s goals and objectives. Identify, hire, train and manage Tissue Donation Specialists in the job requirements for the tissue donation programs. Planning, coordination, and oversight of the daily operations of the Tissue Procurement procedures.  Ensure compliance with established SOPs in the execution of all aspects of the tissue programs, including all qualified site personnel and internal resources. Conduct training of internal resources, TBMD and personnel at the qualified donation sites as changes are made and/or as required. Ensure programs comply with Good Tissue Practices, FDA requirements, AATB and state/local regulations/standards through communications with Regulatory Affairs and periodic review of Regulatory Binders at the qualified donation sites. Assist in the execution of corrective measures to remedy deficiencies cited in audits of the tissue programs. Responsible for ensuring all appropriate tissue program documents are current and updated as required and that documentation is consistently produced with a high level of accuracy and clarity. Assist in the development of Operations Donor Services financial strategies by estimating, forecasting, and anticipating requirements, trends, and variances; aligning monetary resources; developing action plans; measuring and analyzing results; initiating corrective actions; minimizing the impact of variances. Coordinate the file reviews with the Tissue Bank Medical Director (TBMD) and/or designee. Provide needed records and supplies to the tissue donation sites and schedule the timely auditing of completed forms. Audit donation sites for Donor medical records and assessment records and site audits. Assist in the identification, qualification and initiation of new donation sites. Assist in the communication and management of activities related to Tissue Recovery Agencies.

Massachusetts, United States

• Responsible for cross-functional project planning, budgeting, management, and implementation of high impact and high visibility Corporate projects within an FDA regulated (i.e., Biologics and Medical Device) advanced cell-based therapeutic industry.• Key liaison between project teams and all levels of management to secure appropriate resourcing, project definition, capital appropriations and alignment among Team members to ensure clarity regarding accountability for deliverables and timelines.• Lead project manager to facilitate multiple short to long term Corporate initiatives to achieve timely implementation of critical materials and process changes related to membrane and plastics technologies, sterile barrier pouches, efficiencies in aseptic processing, risk mitigation strategies, stability studies, and material/process validations. • Key organizer and driver of Design Control (DHF) activities. Including but not limited to; timeline creation, information gathering, status updates, sign off coordination, etc. • Worked in conjunction with the Director of Project Management to established Portfolio Management Office (PMO) within the Organization• Responsible for the Initiation, Planning, Execution, Monitoring and Completion of multiple concurrent projects • Create, monitor, changed and closed project timelines though Microsoft Project Software• Deliver routine project status reports and updates, including metrics to track progress at Executive Steering Committee meetings.• Project Manager for new product (Gintuit) including, clinical trials, PLI, BLA preparation/submission/approval and launch• Manage war room activities during FDA inspections (local offices and Team Biologics)• Proficient in: Microsoft Office: Project, Excel, PowerPoint

Certificate Of Project Management, Project Management

Bachelor Of Science (Bs), Biology, Chemistry, Psychology

Activities and Societies: Sigma Sigma Sigma National Sorority - Held Vice President and Membership Recruitment Positions