A highly motivated, results-oriented senior project manager with extensive experience in the fast-paced cGMP biopharmaceutical facility environment. Expertise in leading cross-functional teams, developing strategy and facilitating technology transfer of cell culture and purification processes from the development labs to manufacturing. In depth understanding of optimization, scale-up and characterization of upstream and downstream processes. Experience in the development and implementation of process validation plans. Experience in analytical assay development, validation and transfer. Proficiency in a variety of analytical techniques including molecular biology methods. Noted for having exemplary skills in prioritizing and planning work to complete all projects efficiently and on budget. Consistently acknowledged by management as a true team member, excellent communicator and outstanding performer.
July 2012 to December 2012
Plant operations expert supporting technical writing staff for technical documentation to meet new guidelines and FDA requirements. Working collaboratively with SME’s, project managers and technical writers to develop, maintain and modify corporate standards, production records and manufacturing procedures for process and equipment.
Senior Project Manager
January 1999 to July 2011
Developed strategy and facilitated technology transfer of processes from development labs to GMP manufacturing facilities. Coordinated development, clinical, commercial and process validation campaigns for manufacturing of various recombinant proteins. Led multifunctional teams and acted as liaison between manufacturing, the quality and regulatory units and the development groups. Chaired associated meetings, prepared agendas and minutes. Provided stakeholders with timely project updates. Ensured that project goals and milestones were achieved. Provided support for regulatory submissions. Generated timelines, tech transfer documents, campaign summary reports and project close-out analysis. Coordinated investigations into process deviations and implementation of CAPAs. Led the Raw Materials Technical Team to manage technical aspects of raw materials issues. Member of task force for raw material related issues, supplier qualification and change control. Expertise in MS Project, Trackwise, LIMS, SAP, JMP.
• Spearheaded technology transfer from development to commercial manufacturing for four critical new biopharmaceuticals: BAP (Alzheimer’s), BMP (bone growth), Enbrel (rheumatoid arthritis) and FIX (Hemophilia).
• Managed technology transfer of numerous novel biopharmaceutical processes from development laboratory to clinical manufacturing meeting demand requirements for delivery of drug substance for clinical trials.
• Revised and implemented tech transfer procedures in alignment with Future State Design recommendations to assure a successful transfer program.
• Made critical contributions to the effort to streamline the technical transfer process which resulted in the ability to achieve successful transfers with more aggressive timelines.
• Created risk-based strategies for technical assessment of raw material and component change controls and recommended further action.
• Achieved high competency level in the development and optimization of Bill of Materials format for biopharmaceutical processes which enables optimum, cost-effective procurement of materials.
• Authored CMC raw material section of IND filings for numerous products.
Scientist - Mammalian and Microbial Cell Sciences
May 1992 to January 1999
Acted as prime lab resource on analytical issues, providing high quality analytical support. Advanced training in HPLC methodology. Expertise in protein purification chromatographic techniques. Proficiency in basic cell culture and cell line development methods and in a variety of molecular biology techniques (PCR, ELISA, blots, gels). Responsibilities included: assay development and validation; recommending new procedures and approaches towards better evaluation of the cell culture process steps and purification of proteins; operating and maintaining analytical equipment and supplies; recommending the purchase of new equipment; training lab personnel; interfacing with other groups on analytical issues; delivering written reports and oral presentations.
• Significantly increased the scope of analytical procedures available to the lab, increasing productivity and consistency of recovery and clarification processes.
• Made critical contributions to a number of Genetics Institute’s development projects; developing and supporting the rhIL-11 fusion protein assay - a crucial component of Phase III development effort.
• Conducted small-scale process development experiments to evaluate potential improvements to the manufacturing process.
• Transferred, optimized and supported assays to evaluate cell line and cell culture development.
Research Scientist - Membrane Chromatography Dept
Conducted research on applications of membrane chromatography leading to new products; assisted manufacturing, Quality Control and Marketing in establishing procedures; delivered written reports and oral presentations on technical developments and feasibility studies; worked on scale up prototypes for protein purification; provided support to Sales and Marketing before, during and after product launch via seminars, workshops and posters; trained sales representatives.
• Performed evaluation study of Amicon and competitor technology in supporting market introduction of a new line of products
• Performed feasibility studies on several applications leading to new products
Co-founder of Amicon's Analytical Services Group providing the Company with routine and non-routine support services and methods development using a collection of specialized instruments such as HPLC, GC, IR, FTIR, Elemental Analyzer, Surface Area and Particle Size Analyzer, etc. Provided instrumentation maintenance and acted as liaison to outside vendors for characterization beyond the Group's capabilities. Identified and procured new instruments.
• Developed a test method for Molecular Weight cut-off determination of ultrafiltration membranes by Gel Permeation Chromatography, which significantly improved the quality of produced membranes.
• Designed and organized a system of operating the Analytical Services Department
Master of Science in Environmental Engineeering
Fluent in Polish and Russian