Engineer Process

DONALD R FONTES

* *** ******* ******, ***********, MASSACHUSETTS 01581

508-***-**** [H] | 508-***-**** [C] | *******@*****.***

SUMMARY

Process Engineer / Lab Manager with more than 15 years of experience in cell culture, process development, and raw materials testing in the biotech industry.

HIGHLIGHTS

Process Engineering Lab Management

• CHO Cell Culture Process Development

• Viral risk mitigation investigations • Provide users with all aspects lab needs (warm rooms, gases, equipment set-up)

• Bench and small scale protein therapeutic processes • Cell Culture and training database administration

• Lab materials ordering

• Raw materials investigations • SOP generation and administration

• YSI, BGA, ViCell, Osmometer use • Lab set-up and commissioning

EXPERIENCE

GENZYME CORPORATION, Framingham, MA 1996-2011

Process Engineer II - Laboratory Management

Provided laboratory services and supplies to department members and outside users to ensure timely completion of experiments/studies.

• Selected to a team to design and commission a new laboratory to double small scale cell culture capacity and add eight pilot scale (40L) reactors.

• Configured warm-room and lab space for cGMP-like operation for serum testing, preventing stock-out of qualified serum stoppage of production.

• Improved ordering/stocking of lab supplies. Ensured supplies were always available as department doubled in size.

• Maintained/revised the Plateau training database. Ensured that all personnel were properly trained to safely and effectively perform laboratory functions.

Process Engineer II - Raw Materials

Investigated the effect of changes to raw material sourcing and processing on cell culture growth and productivity.

• Investigated the UVC treatment of medium for viral inactivation. Demonstrated that the UVC treatment had no adverse effect on CHO cell growth or productivity.

• Developed a growth promotion assay for gamma irradiated serum for use with CHO cell lines that was more robust and more accurate than the previous assay.

• Supported cell-culture based investigations into the potential root cause of Myozyme and Cerezyme bioreactor failures, identifying that the root cause of the failure was viral contamination.

• Supported cell-culture based investigation into the potential root cause of a Fabrazyme bioreactor failure, determining that the root cause was not a viral contamination.

Process Engineer I/II - Process Development

Developed cell culture processes for the manufacture of therapeutic proteins.

• Developed a modified roller-bottle seed train method for Myozyme which was more robust than the conventional spinner method, providing a shorter growth phase duration and increased productivity.

• Worked with a four-person team to develop Myozyme process limits, preventing minor excursions from declaring a batch unusable.

• Worked with a team to complete the Fabrazyme process development at the 10L scale. Delivered the process by the target date, ensuring the first submission to the FDA.

• Maintained the in-house cell culture database. Ensured the experiments were created / terminated to correctly reflect current lab work.

Process Engineer I / AIM SCADA Administrator (1996-1999)

Maintained and configured the AIM database system to provide operational during the Allston plant’s testing and validation phases.

• Controlled and maintained the AIM SCADA system. Ensured real-time, accurate data from the Allston plant was available for analysis.

• Configured the majority of the database tags reported. Increased initial database configuration threefold. Created calculations to reduce WFI usage during reactor cleaning.

GTE GOVERNMENT SYSTEMS, Westborough, MA / Needham, MA

Software Engineer

USAF Officer

Missile Launch Officer / Computer Programmer

EDUCATION

Master of Science, Management, UNIVERSITY OF NORTHERN COLORADO

Bachelor of Science, Microbiology, UNIVERSITY OF MASSACHUSETTS

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