Solutions-focused Chemical/Product Development Engineer specializing in the Biotech/Medical Device industry eager to contribute technical proficiencies as well as dynamic project management skills toward supporting the employer in optimizing results.

 

 

         Excel in conducting broad-based research experiments, analyzing complex data, and interpreting and presenting results; highly skilled in sterilization validation and ISO 11137 compliance.

         Adept at IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification).

         Exemplary ability to quickly master new roles, tasks, technologies, challenges and responsibilities.

         Strong knowledge in various sterilization techniques and biocompatibility test methods.

         Display a collaborative work ethic, outstanding communication and interpersonal skills, and a superior level of initiative and self-management.

         Solid abilities in laboratory safety management, personnel training, and project management.

         Strive to optimize product performance, quality, and reliability through novel processes and materials.

 

 

AxoGen Inc., 2006 to 2009  

Product Development Technician

         Applied significant project management expertise toward preparing and presenting new technology assessments to executive management, vital to future product development in peripheral nerve repair.

         Played an integral role in design, development, and execution of strategy which doubled manufacturing throughput and reduced cost by 20%.

         Expertly created design validations, performed PQ testing, established criteria for inspection documentation, and formulated new processing components specifications.

         Demonstrated sharp leadership skills in coordinating and steering NCR and CAPA investigations.

         Navigated strict compliance with regulatory requirements and good manufacturing practices through proficiency in SOP documentation and batch records administration.

         Improved product development efforts by innovatively co-developing an allograft tracking system complete with corresponding specifications, inspection documents, and operating procedures.

         Seamlessly cooperated with quality and regulatory team, manufacturing, and product development staff to expedite product launches and process development activities.

 

Vistakon, Johnson & Johnson Vision Care Inc. (Kelly Scientific), 2005 to 2006 

Research Associate     

         Expedited and streamlined work processes by 15% through expertise in identifying and implementing procedural improvements and assisting in completing NCR investigations.

         Qualified Labware LIMS/ Empower interface to automate transfer, review and release of data in a paperless e-signature environment.

         Spearheaded validation of equipment through execution of IQ/OQ/PQ procedures, compiled Operator Instructions, and edited validation documents.

         Planned, coordinated and meticulously documented contact lens compatibility studies with contact lens solutions for submission to Japanese regulatory agency, Shonin.

         Demonstrated sterling leadership capabilities in training, coaching and supervising personnel in proper use of lab equipment.

 

Continued

 

 

Professional Experience continued                                                           Yyyyyy x. yyyyyy, Page 2 of 2

 

Baxter Healthcare, (Kelly Scientific), 2005

Validation Associate

• Participated in analyzing, creating and executing validation protocols for integration testing of bloodlines for dialysis treatment administered via Baxter Arena Machines.
• Relied upon to specify, install, and test equipment, perform IQ/OQ/PQ, analyze results, and prepare validation documentation.
• Conducted thorough process studies and exhibited considerable talents in statistical analysis.

 

Mount Sinai Medical Center, 2002 (summer)

Research Assistant    

• Recognized and acknowledged in a published paper for research contributions in Desnick lab.
• Completed several experiments with blood, cell culture, and tissue culture, leveraging various biochemical methods to support molecular genetics, pharmacogenomics, and functional genomics research projects.
• Utilized statistical analysis to explore chromosomal linkage and modes of inheritance.

 

Schick Wilkinson Sword, Energizer Holdings Inc., 2000 to 2001

Co-op Chemical Engineer

• Continually optimized product development activities by troubleshooting, analyzing and optimizing extrusion and injection molding performance of novel polymer blends.
• Resourcefully initiated and conducted comprehensive studies for claims substantiation of additive agents used in lubricating strip.
• Inspected and tested raw and finished polymeric materials to ensure strict quality control.

 

Polytechnic Institute, 1999 (summer)

Research Assistant

• Exercised keen investigative abilities to diligently conduct experiments in polymer science and engineering, and explore sol-gel reactions of reactive silanes as corrosive-preventative surface modification treatments.

 

Prior background includes role as Financial Advisor for E1 Asset Management, 2005

 

 

B.S., Chemical Engineering, Rensselaer Polytechnic Institute, Troy, NY, 2003

Six Sigma Green Belt

CAPA, FMEA, Process Validation, Design Validation, DOE, GMP, GLP

Kepner-Tregoe Problem Solving and Decision Making

Testing for Medical Products and Devices Workshop: Wuxi Apptec

 

 

Microsoft Office Suite (PowerPoint, Word, Excel), Microsoft Project, Microsoft Visio, SolidWorks, Maple, Matlab, LABView, Minitab, Simulink, Mathematica

 

 

Member, American Association for the Advancement of Science

Member, American Institute of Chemical Engineers

Recipient, ACS Award for Outstanding Laboratory Performance in Analytical Chemistry Course

 

 

 

 

 

 

Date

 

 

Hiring Agent Name

Title

Company Name

Address

City/State/Zip Code

 

Dear__________________:

 

I am currently seeking a challenging career opportunity in a Chemical Engineering capacity and am submitting my resume for your review.  In advance, thank you for your time and consideration.

 

As indicated in the accompanying resume, I bring to you an outstanding background in product development and optimization, exceptional talents in quality control and assurance, and excellent abilities in biotechnology, equipment validation, and medical-based research. To complement these qualifications, I offer solid planning, documentation, prioritization, and communication skills.

 

As a proactive contributor to your organization, you will find me to be a highly motivated professional committed to supporting you in achieving your objectives through superior self-initiative, unparalleled resourcefulness, and well-honed leadership attributes. I am extremely confident that I could be a valuable asset to <insert name of organization>, and look forward to interviewing with you in the near future. 

 

Sincerely,

 

 

 

Yyyyyy x. yyyyyy