Tracee Gruber
Denver,CO
Summary
Highly experienced Executive with 20+ years in Operations, Manufacturing, Quality, and Regulatory. Expert in FDA - CFR 21 Part 1271 and Part 820 Regulations, AATB - Standards for Tissue Banking, and EBAA - Medical Standards. Skilled in ISO 11137, 13408, 13485, 9001, and 14644. Results-driven leader experienced in developing network strategy and facilities, leading diverse teams, and designing new products and logistical plans.
Overview
28
28
years of professional experience
Work History
Chief Operating Officer
Lucina BioSciences, LLC
Denver, USA
01.2019 - Current
- All aspects of a startup company with respect to the design and launch of a new tissue bank for the Distribution of HCT/P products to new customers, Acquisition/Recovery, Processing, and Manufacturing
- Developed relationships with physicians, hospitals, and OB/GYN facilities to execute MOUs for birth mother’s rights to donate their placenta and to transplant newly launched products
- Establish a tissue bank for planning and inventory control, cost management, write and submit reports on cost analysis, budget, trending all training, facilities, employment development, safety, quality assurance, FDA/ISO/AATB compliance, and performance management
- Responsible for the management oversight of the facility, equipment, maintenance, and manufacturing processes to ensure that the organization is fully compliant with FDA CFR Title 21, Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals, FDA CFR Title 21, Part 1271 Human Cells, Tissues and Cellular and Tissue-Based Products, USP Pharmaceutical Compounding - Sterile Preparations, and federal, state, and local laws and regulations, where applicable
- Primary responsibilities include, but are not limited to:
- Collaborate with the CEO in setting and driving organizational vision, operational strategy, and hiring needs
- Translate strategy into actionable goals for performance and growth, helping to implement organization-wide goal setting, performance management, and annual operating planning
- Oversee company operations and personnel productivity, building a highly inclusive culture, ensuring team members thrive and organizational outcomes are met
- Developing and implementing strategies, procedures, and business plans needed to enhance company growth
- As the Officer for the FDA managed, performed, and successfully completed all inspections and audits with no 483’s nor observations
- Working closely with Lucina’s CSO to develop and manufacture new products to be on the cutting edge of the tissue bank industry
- Validate processes in addition to working with patent attorneys to write, design, and implement Lucina process patents
- Excellent communication skills, task-driven to meet timelines, and multitasking while overseeing two facilities and a buildout of the Lucina facility of ISO 5 cleanrooms
- Designed and performed various equipment qualifications and processing and sterilization validations
- Writing and implementing all company administrative, quality, safety, and operations policies and procedures
- Acquiring and maintaining relationships to drive extensive and sustainable growth through the hospitals (CEO and legal), birth tissue providers (OB/GYN), other birth tissue processing agencies, and tissue recovery partners for the placental tissue
- Identifying and qualifying all suppliers for the business
- Conduct all internal and external audits
- Handle all regulatory licensing for all states as well as FDA
- Negotiating contracts with all hospitals, birth tissue acquisition providers, processors, laboratories, and all other vendors providing services to the tissue bank
- Drive the company to achieve and surpass sales with our distribution partners
Director, Medical Eye Bank of Maryland
KeraLink International (Formally Tissue Banks International)
Baltimore, USA
03.2016 - 12.2016
- Ran the operations of one of the largest eye banks on the East Coast
- Ensured relationships were at the highest level to be able to provide transplantable corneas domestically and internationally
- Designed the new eye bank facility and (4) ISO 5 cleanrooms to merge the corporate office with the leading eye bank of Tissue Banks International
- Selected and ordered new equipment for the facility
- Designed and performed various equipment qualifications and processing and sterilization validations
- Trained staff on new equipment and processes
- Wrote and implemented processing policies and procedures
- Managed the event, complaint, and CAPA system
- Developed new processing and manufacturing techniques and successfully trained technicians on DSAEK, ALK, and DMEK cornea graft preparation
- Created a new method for preparing DMEK cornea grafts for transplant
- Handled regulatory licensing for all locations
- Established and maintained multiple tissue recovery agency relationships across the nation
- During my reign, we had successful site inspections
- Build relationships with C-Level executives at the hospitals, family aftercare, and call centers of the recovery agencies
- Worked as the primary liaison between funeral homes, coroners’ offices, and medical examiners for the acquisition agreements with all Recovery Partners across the US
- Established and maintained multiple organ, ocular, and tissue recovery partner relationships across the nation
- Tracked and trended all musculoskeletal, cardiovascular, skin, and cornea contamination and error rates
- Set the standard for each partner on donor numbers, organized the training with Tissue Banks International, national trainer when errors were higher than the set goal
- Managed relationships between Evaluating, Processing, and Releasing eligible tissue for transplant and R&D
Director of Operations
Winter Institute for Simulation Education and Research (WISER), University of Pittsburgh Medical Center
Pittsburgh, USA
08.2009 - 01.2011
- Responsible for fostering relationships within the healthcare and DOD in the advancement of healthcare simulation and education to improve patient safety, education, mentorship, systems design, and research to enhance the high-quality delivery of healthcare
- Introduce the UPMC methodology of simulation and instruction to the DCMT by utilizing the expertise of WISER
- Development of Curriculum and documentation management
- Grantsmanship – Having intense focus, solid research, great attention to detail, and clear, concise language
Associate Director, Recovery Services & Eye Division
Center for Organ Recovery and Education (CORE)
Pittsburgh, USA
08.2008 - 08.2010
- Handled the day-to-day operations of the clinical staff of the most extensive cross-trained Organ Procurement Organization (OPO)
- Negotiated contracts with all partners and vendors
- Responsible for ensuring metrics were achieved and developing/implementing corrective action plans as needed to achieve goals
- Managed a team of over 80 plus employees from three departments
- Was one of three AOC’s (Attending on Call) making decisions on what organ went to what patient per UNOS guidelines and working with transplant surgeons through the call center, in addition to making final decisions on all tissue, and corneal recoveries
- Worked closely with the CEO and COO daily in making decisions about cadaveric tissue recovery, DCD organ donors and brain-dead donors
- Was responsible for all R&D programs and cutting-edge practices that led CORE over 5M their first year with a new full thickness skin recovery which provided the capability to expand onsite operating rooms
- Oversight of an ocular recovery/processing center to ensure corneal transplants were met
- Managed the donor eligibility and tissue suitability department, biologics manufacturing department, and human allograft distribution department
Licensed Mortician and Funeral Director
Schimunek Funeral Home
Baltimore, USA
03.1997 - 01.2001
- Professionally handled the details of burials, cremations, and funerals
- Responsible for embalming, dressing, and preparing the deceased for viewing
- Prepared legal documents for the deceased and their families
- Secure the death certificate with the respective counties and make sure the family has the documents they need to proceed with insurance
- Arrange funeral services for the deceased at the request of families
- Having knowledge with religious, cultural, and regional customs to provide a meaningful funeral, wake, or graveside service
Education
B.A - Communications
University of Pittsburgh
Associates - Humanities
University of Pittsburgh
Embalming and Funeral Directing -
Pittsburgh Institute of Mortuary Science
Skills
- Leadership
- Integrity
- Commitment to excellence
- Teamwork
- Problem-solving
- Adaptability
- Goal-Oriented Mindset
- Strong Partnership Skills
- Manufacturing Expertise
- Strategic Partnership Development
- Supply Chain Management
- Budgeting and forecasting
- Quality Control Expertise
- Identify New Revenue Opportunities
- Operational Efficiency
- Product Strategy Development
- Commitment to Professional Standards
Timeline
Chief Operating Officer
Lucina BioSciences, LLC
01.2019 - Current
Director, Medical Eye Bank of Maryland
KeraLink International (Formally Tissue Banks International)
03.2016 - 12.2016
Director of Operations
Winter Institute for Simulation Education and Research (WISER), University of Pittsburgh Medical Center
08.2009 - 01.2011
Associate Director, Recovery Services & Eye Division
Center for Organ Recovery and Education (CORE)
08.2008 - 08.2010
Licensed Mortician and Funeral Director
Schimunek Funeral Home
03.1997 - 01.2001
B.A - Communications
University of Pittsburgh
Associates - Humanities
University of Pittsburgh
Embalming and Funeral Directing -
Pittsburgh Institute of Mortuary Science
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