Fred Drewe 9294 Scenic Bluff Drive Austin, TX 78733 512-200-5390 docnzym@yahoo.com OBJECTIVE A position in the biotechnology field where innovation and the capacity to learn new technologies and techniques is required. Where the need to have the courage and confidence to take risks and to learn from mistakes is highly desirable. EXPERIENCE Product Development, Process Improvement, & Product Transfer Highly self-motivated and able to work individually or as part of a group effort Developed over a hundred new protein products from initial research to transfer to manufacturing. Derived from many sources. Plants, animal, human and cultured cells Many protein products were derived from the same batch significantly reducing the cost of the source material and initial purification steps Techniques used in the development included tangential filtration, large and small scale column chromatography, EIA/ELISA, Western Blots, Protein/DNA/RNA extractions and miniculations , proteomics, and microarrays, RT-PCR/qPCR and cell culture were also used for generating sources for proteins Involved in the improvement of existing purification procedures by using new equipment and techniques not excluding chromatography media, chromatography supports, and ultrafiltration equipment. Assay development from inception to final validation. Protein Biochemistry Purification procedures have always been developed or improved using the latest techniques while not forgetting the classic ones such as calcium phosphate Stabilization of protein based products for liquid storage conditions, lyophilization and use in calibrators and controls. Various techniques used including pseudo substrates or products Scale has ranged from less than a liter up to 15,000 liter batches. One product derived from a fermentation process was of the volume of about 125,000 liters per week Able and willing to work on several projects at a time with efficiency and thoroughness Documentation/Standards Responsible for the development and implementation of ISO9000/13485 and GMP/GLP based quality systems at several companies Development of hundreds of documents to support raw material procurement, analytical procedures, purification processes, and final product QC Analytical Skills Extensive assay development experience including enzyme kinetics based on UV, Visible, Fluorescence detection, immunoassays, HPLC, GC, CE, and MS based ones Development of long term stable controls and calibrators to go with both existing and new assay procedures and products Responsible for the maintenance of the major analytical instruments and training of personal for the use on such during the majority of my employment Problem Solving & Trouble Shooting Problem solving abilities ranging from the recovery of incorrect batches due to lack of QC approval to fast product development. Finished developing a hypertension protein purification procedure and its testing within a six week period. Called upon numerous times to determine how to correct a mistake in batch formulation to non conforming stages in a upstream or downstream procedure. Laboratory Management Training of employees in Quality System regulations, instrument maintenance and calibration, and the manufacturing of products was a routine part of my jobs. Supervision experience in both the research area and manufacturing. Able to coordinate the efforts of product development staff with the manufacturing staff and QC/QA departments. Able to function at a high level both independently and within a cross-functional team effort. Able to do both of these in the same period of time. PROFESSIONAL EXPERIENCE DBS Biosolutions Lee Biosolutions Inc Drewe Browning Strickler Inc Consolidated Technologies Inc (part of ThermoFisher) Aalto Scientific Inc Beckman Instruments ICN Biochemical/Radiochemical EDUCATION PhD in Biochemistry 1984 Minor in Physical Organic Chemistry University of California, Riverside Riverside, CA COMPUTER SKILLS Proficient in MS Office, MS Project and other Project Management software, Creative Suite, Minitab, DOE and other statistical/data handling software MEMBERSHIPS American Chemical Society American Association of Clinical Chemists American Association for Advancement of Sciences American Society for Quality