David Willow Email & Phone Number

Formulation and manufacturing process development of therapeutic proteins.-Characterization of various prototype formulations using biophysical and biochemical techniques.-Solved technical problems related to the stabilization of liquid and lyophilized formulation proteins.-Planned, conducted, and interpreted routine and non-routine experiments.-Documentation including experimental reports. -Presented technical data that contribute to external publications.-Worked in a cross-functional team that supported multiple areas of product development and optimization.-Design product stress scenarios and analyze products at set time points to generate stability data.-Develop testing procedures for new products, instruments, and FDA required material specifications. -Recorded experimental data electronically using eLN.

Built equipment to fill processing kits and sterilized using an autoclave. -Operated systems to perform micro, ultra and sterile filtration.-Extracted target proteins from genetically modified cells via homogenization.-Utilized column chromatography to isolated and purify specific proteins.-Inoculated and fermented frozen working seed to specific concentration then inactivated for filtration.-Clarified fermentation broth after flocculation using centrifugation in addition to cellulose or carbon filtration. -Maintained real-time documentation according to cGMP documentation practices. -Purified polysaccharides via fractionation by t-mixing with IPA or ethanol followed by centrifugation.-Performed in-process checks and assisted in developmental work pertaining to production methods-Followed cGMP guidelines and utilized aseptic techniques to manufacture a sterile vaccine of the highest quality.-Maintained communication with managers, facilitators, and technicians to safely meet production goals-Troubleshoot and worked to correct mechanical, logistical, and scheduling issues-Controlled manufacturing equipment via automated systems or manual operations in compliance with safety, company, and government regulations.-Cleaned, assembled, operated, disassembled, and maintained all production equipment.-Initiated and documented corrective actions as required to meet production schedules including deviation reports when necessary.

Communicate between customers, production, and product release to facilitate and ensure the end customers' needs were met for each product-Forecast and prepare all purchase orders for necessary materials for continuous production and site upkeep-Prepared all necessary QA/QC and shipment paperwork for scheduled shipments to ensure 100% accuracy -Created spreadsheets to illustrate production schedule, inventory, release status, pending orders, and delivery dates -Work with QA/QC to identify and resolve customer complaint issues, if needed ensure a proper investigation, assist in execution of CAPA's and follow though on our commitments.-Resolved purchasing issues concerning billing, services rendered, or products received-Solicited sales of new or additional material to new and existing customers-Evaluated cost effectiveness of current vendors and recommend new vendors when appropriate for cost, quality or supply reasons-Provided project management and daily site operation support for the General Manager and Managing Director

Stroudsburg, Pa

Assisted in developing and modifying procedures for testing methods-Validated and qualified new equipment and production procedure (IQ/OQ/PQ) -Trained new chemists on all procedures and instrumental analysis-Oversaw operation of all employees to meet deadlines through utilization of teamwork and time management -Calibrated and maintained all laboratory instruments (HPLC, UV-Spec., Scales, Thermometers, Autotitrator, FT-IR, AA Spec. and Pipettes) -Tested and documented all information pertaining to lab investigations- Reviewed documentation of SMF, batch record, and FG testing for product release approval.

Stroudsburg, Pa

-Prepared all buffers and testing solutions -Performed sterile sampling of all stabilities, raw material, in-process material, and finished goods-Tested all material through instrumental analysis and wet chemistry-Documented procedures, calculations, and results as per U.S.P.