LEONARD M. HERNANDEZ
North Bergen, NJ 07047
Mobile: 201-***-**** Email: ***************@***.***
SUMMARY OF QUALIFICATIONS
Accomplished project/product manager, marketing analyst and technical writer with a unique background in sales,
marketing and scientific manufacturing environments. Proven expertise in conceptualizing ideas and processes to
optimize efficiencies in stem cell and tissue manufacturing environments. Experience with AABB, AATB, FDA, ISO,
OSHA, cGMP, cGTP, GLP, GCP and 21CFR regulations, with a focus in blood banking and clinical manufacturing
environments.
PROFESSIONAL EXPERIENCE
BEL-ART PRODUCTS INC., Pequannock, New Jersey
Product/Category Manager (2007-Present)
Reporting directly to the Vice President of Sales & Marketing
Product Management of 4000 in-house manufactured products that service the science industry which includes the
complete line of Sterileware® products and Spinbar® Magnetic Stirring Bars.
Responsible for product line category management and gap identification.
Prepare detailed product management plans, financial reports, market analysis, trend analysis, forecasts, and
Statements of Work (SOW) for potential new products.
Conduct market research on potential new product lines.
Chaperone new products through the approval process and through major distribution channels.
Liaise between suppliers and companies on purchased and distributed materials.
Communicate with regulatory consultants regarding company products that are OSHA or FDA regulated.
Interact with the Engineering, Operations and Customer Service departments to discuss technical details of
products and product launch schedules.
Develop promotions and new product advertisement campaigns, websites listings and new product literature.
Present new products at trade shows.
Create catalog copy, tag lines, and products names for all marketing materials.
Communicate with end users on all product related issues, including technical support.
Train Sales Representatives on company products and sales techniques.
ACCUREG, INC., Ft. Lauderdale, Florida
Regulatory Consultant (Present)
Sr. Project Manager/Regulatory Consultant (2007)
Reporting directly to the President
Communicated directly with clients to ensure project work flow, progress and client satisfaction.
Developed and maintained project (resource and task allocation) schedules for extended client projects.
Prepared detailed project management plans, confidentiality agreements, master agreements, Statements of Work
(SOW), project proposals and project metrics
Managed allocation of tasks to personnel to ensure projects are completed on time and within budget.
CELGENE CELLULAR THERAPEUTICS, Cedar Knolls, New Jersey (2001 – 2006)
Stem Cell Manufacturing Supervisor (2003 – 2006)
Consulted with sales and marketing teams in connection with the development of new product names. Result:
Assisted in the development of product names such as Biovance and Accelagraft.
Developed and implemented an inter-departmental cross training program for laboratory technicians, which
resulted in operating cost-savings.
Completed a one (1) year gap analysis on an approved process for a patented laboratory technique.
Conducted process improvement studies and created financial reports for each manufactured product.
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Supervised staff on a daily basis, conducted yearly employee reviews and assigned daily work schedules. Result:
Produced a hard working team of technicians who consistently met goals and timelines required for research and
development purposes.
Trained newly hired technicians at the Baton Rouge, LA site. Result: This training accelerated the launch of the
newly constructed site, and helped to build the bank of stem cells for research purposes.
Created multiple Standard Operating Procedures (SOPs) and batch records which led to ISO Certification in 2005.
Managed extensive process improvements for improving techniques, yields, manufacturing times and processing
equipment.
Initiated all CAPAS/Non-Conformances, OOS/OOT reports, investigations and change control forms.
Implemented procedures for shipping bio-hazardous materials off site for testing, in accordance with IATA
regulations
Recommended the use of a laser to cut a tissue based wound covering. Result: The use of this laser cut the
amniotic tissue based wound covering more accurately and in a fraction of the time.
Stem Cell Laboratory Technician III--Acting Supervisor (2003)
Member of the Stemlab design team which validated a custom electronic computer database that provided the
storage of manufacturing and clinical information, streamlined laboratory processes and enabled the company to
reach its maximum production possibility frontier.
Isolated and cryo-preserved placental stem cells. Result: Helped the company to build up their placental stem cell
bank of research and development material used for clinical trials to discover future medical applications.
Trained all newly hired technicians on processes and procedures required to increase production of research and
development material. Created the first SOP for the company on isolating and cryopreserving placental stem cells.
Research Associate (2001- 2002)
In conjunction with Dr. Robert Hariri, HLA typed blood samples from ALS patients involved in clinical trials
with umbilical cord blood stem cells and placental stem cells. Result: Patients were transfused with non-matched
allogeneic umbilical cord blood stem cells. The HLA typing data provided the company with possibilities of
future medical applications of umbilical cord blood.
Custom designed equipment used for processing placental stem cells. Result: This design saved the company
thousands of dollars in hiring an outside professional engineer.
Managed, reported and presented clinical trials data to upper management on a weekly basis to facilitate
development of FDA-approved products.
Stem Cell Laboratory Technician I (2001)
Isolated and cryopreserved umbilical cord blood stem cells. Result: A high quality standard was established for
the company, and the number of stored umbilical cord units rapidly increased.
EDUCATIONAL EXPERIENCE
Nova Southeastern University, Ft. Lauderdale, FL (2006 – 2008)
Master of Business Administration (MBA)
Rutgers University, New Brunswick, NJ (1998 – 2002)
BS in Biotechnology / Minor in Biochemistry
SKILLS & RELATIVE COURSES
Bilingual: English & Spanish
Microsoft Office
The Dale Carnegie Course
Licensed New Jersey Realtor Associate
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