Lead the daily cell culture activities in a clinical trial manufacturing operation.Author / update on the job (OJTs) documents, mentor and train less experienced team members.

Lead the daily cell culture activities in a clinical trial manufacturing operation.Author / update on the job (OJTs) documents, mentor and train less experienced team members.

Clinical production of monoclonal antibodies and enzymes in stirred vessel and single use bioreactors.36L benchtop scale Bioreactor process: thawing, scaling up (utilizing roller bottles and spinner flasks), building, and autoclaving vessels. Routine daily sampling, viral sampling, daily harvest retain assay test coordination, and end of production sampling. Production of research grade and GMP therapeutic proteins at 500L scale utilizing the 500L Hyclone SUB. Thawing, scaling up (utilizing shake flasks, wave bioreactor, and 100L SUB), preparation of the SUB vessels and probes, daily sampling, end of production, harvest clarification. 50L SUB perfusion process operations. Author / update SOP’sMetrology lead for the CTM-USP group. Successfully ensured calibrations, preventative maintenance, and vendor services have been completed on time. Coordinated the Metrology Global harmonization and data management project for CTM-USP.

Commercial Cell Culture Development team member. Compound and produce media and buffer, sterile filtration and fill components in a GLP environment. Assay component metabolites to assure compliance with specifications. Build and aseptically process cell culture equipment. cGMP Therapeutic Products Laboratory Support.

Communicated directly with customers to ensure that products were in compliance with all technical paper specifications, resulting in fewer down stream quality issues.Coordinated the planning, production and sales efforts for developing new products and implemented new additive technology, yielding up to a 25% increase in customer product throughput.Maintained statistical database and analyzed product properties, resulting in tighter process control.Developed commercial trials, established product specifications, documented results, and performed on site customer technical support and product claim investigations to assure successful future production and retention of key North American customers.Spearheaded the team that brought to market the first 100% recycled print base paper in the laminate industry.Maintained all physical specifications, color standards, and formation standards for each grade. Implemented color search database, enabling quicker product recipe formulation and expedited customer quotes.Supported customer service with order entry, confirmation, and product shipment releases. Administered company Forest Stewardship Council certification, resulting in 100% product line transfer for key customers and successfully maintained compliance in accordance with the FSC chain of custody specifications. Verified chain of custody certification for both suppliers and customers.

Supervised four quality assurance technicians in a manufacturing environment. Responsibilities included hiring, training, and periodic performance evaluations of technicians.Developed and maintained standard operating procedures, yielding consistent data.Performed new product research and successfully developed two hundred twenty-seven grades of paper for commercial production. Provided technical assistance while conducting new product trial grade runs. Controlled laboratory inventory supplies and chemical reagents

Evaluated and insured the quality of new dyestuffs, chemicals, and pulps. Analyzed the manufactured product, utilizing Technical Association of Pulp and Paper Industry test methodology. Support Sales Staff, interface with customers, and performed laboratory work / color matching to satisfy new product inquiries.Maintained New Product Inquiry Database and color standards database for the spectrophotometer Instruments

Analyzed water and soil samples for the presence of inorganic compoundsutilizing Environmental Protection Agency/ASTM methodology.

Assist staff members in the response to customer complaints and inquiries by written, verbal,and on-site communications concerning water quality.Responsibilities included, but were not limited to: monitoring/data entry ofchemical quality test data.Assisted in performance of Water Supply Sanitary Surveys, tracking ofEnforcement Actions, and the collection of water quality samples