Forward-thinking Manager with more than 15 years of manufacturing, technical, and small scale experience in both parenteral and diagnostics environments. Collaborative with dedication to partnering with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings.
Skills
Verbal and written communication
Bench and Process Scale Chromatography
Column Packing up to 1 meter diameter.
Unicorn Software
HPLC / UHPLC
LIMS Software
Work History
Manager, Viral Clearance DSP, 03/2018 - Current W.R. Berkley Corporation – New York, NY,
Manage a team of highly skilled technicians in carrying out the execution of client scale-down processes for Phase I through Phase IV Viral Clearance studies.
Under my leadership, the Viral Clearance DSP Team has increased the number of executed client studies from an average of six per year to over fourteen per year with minimal increase in headcount and without loss of quality.
Prepare client protocols, final reports, risk assessments, investigations, deviations when needed as well as the drafting of a majority of the RFPs and quotations for service that are sent to clients.
Oversee the calibration and preventative maintenance program for 26 AKTA FPLC systems used in the execution of client executed and WuXi executed viral clearance studies.
Provide technical support to clients on downstream purification process with regards to Viral Clearance studies.
Oversee the accurate completion of batch records and other required documentation according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs.
Compile data highlighting key metrics to report information, determine trends and identify methods for improving process flow and On Time Delivery results.
Continuously improving operational planning and operations frameworks to enhance resource utilization and reduce waste of materials and time.
Execute regular process updates to reduce discrepancies and enhance overall quality across multiple viral clearance teams and other internal stake holders.
Develop and maintain relationships with key accounts clients through continual communication and feedback throughout the execution of studies.
Prepared and recommended long-range plans for the combining of the Viral Clearance, DSP and AKTA Maintenance teams into a single functional group.
Manage the continuous Cross-training of existing employees in the department to maximize team agility and performance.
Member of the Automation and New Technology Team tasked with evaluating new processes (continuous chromatography) and equipment to increase overall Testing Group throughput and reduce operating costs.
Present posters at scientific conferences and coordinate with sales and marketing departments to give presentations to key clients and potential new clients on WuXi Viral Clearance services.
Developed four new applications for Tosoh Process Chromatography Media and HPLC columns.
Assisted customers with technical issues and in implementing new products into their manufacturing and analytical processes.
Presented scientific posters and papers to technical conferences.
Evaluated new technologies developed by Tosoh as well as potential OEM manufacturers.
Product Manager, Process Chromatography Media , 01/2013 - 08/2016 Tosoh Bioscience – City, STATE,
Produced all sales and marketing materials for new and legacy products for use by Tosoh Business Development Managers such as Product overviews, Application Notes, Sales Presentations, Web Pages, Catalogues, etc.
Executed the launch of seven new products over the course of three years and drove the increase of market share of all products year over year.
Engaged with current and potential customers on the benefits of using Tosoh resins versus those of our competitors; focusing on value proposition and the benefits that can accrue by choosing Tosoh resins.
Planned and coordinated a minimum of five trade shows each year.
Coordinated three to five off site product seminars at neutral locations across the US each year.
Developed business plans to expand product portfolio through acquisitions of companies, technologies, or product collaborations.
Established and streamlined the annual marketing and advertising budget to maximize ROI for all products.
Established Tosoh's presence in the South American market (Brazil), and worked to introduce Tosoh resins into non-biopharmaceutical applications such as foods and petrochemicals.
Member of the Tosoh Bioscience Global Marketing Team
Technical Specialist, Process Chromatography Media, 08/2010 - 01/2013 Tosoh Bioscience – City, STATE,
Developed new downstream applications for Tosoh process chromatography media.
Assisted customers with technical issues and with the integration of new products into their development pipeline.
Traveled to customer sites across the US to assist with large scale column packing and to assist with troubleshooting of technical issues that required hands on experience.
Presented 12 scientific posters and papers at technical conferences.
Traveled extensively with Tosoh Business Development Managers to present technical data to existing and potential new customers.
Technical Manufacturing Technician II, 02/2004 - 02/2010 Fujirebio Diagnostics Inc. – City, STATE,
Growth and purification of over 25 antibodies and antigens that are used in medical diagnostic kits, as well as for sale as Rare Reagents. As the senior technician in the Bioprocessing Lab, it was my responsibility to ensure that all equipment was properly validated and functioning within established parameters.
Installed and validated multiple AKTA Explorer chromatography systems and designed and developed the requisite process transfer protocols for all existing products to be moved to these new systems.
Developed an alternative manufacturing process for multiple products that resulted in a marked reduction in processing costs and time.
Designed, developed, and executed the transfer of manufacturing processes from an outside client into the OEM pipeline.
Wrote new and edited existing batch records, SOPs, and other support documents as needed.
Education
Bachelor of Science: Business Management , Expected in 10/2001 - University Of Phoenix - King Of Prussia, PA, GPA:
No Degree: Biological And Physical Sciences, Expected in - Shippensburg University Of Pennsylvania - Shippensburg, PA GPA:
Course work towards a degree in Biology completed through Junior Year. However, I had to withdraw due to financial issues.
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Resume Overview
School Attended
University Of Phoenix
Shippensburg University Of Pennsylvania
Job Titles Held:
Manager, Viral Clearance DSP
Senior Technical Specialist
Product Manager, Process Chromatography Media
Technical Specialist, Process Chromatography Media