OBJECTIVE
Associate Director in pharmaceutical development is seeking a challenging position that will utilize advanced skills in the process development, manufacture, technology transfer, validation, quality assurance and regulatory issues for Pharma or medical devices
SUMMARY OF QUALIFICATIONS
Quality & Regulatory
Wrote, reviewed and approved manufacturing documents to achieve compliance including Master Device and Drug Records, SOPs, batch records, investigation reports, CAPA, OOS, non-conformances, change control, deviations, package inserts and MSDSs. Coordinated validation efforts to address FDA guidelines for facility registration including master plan, protocol development, FMEA, QbD and PAI. Instructed personnel on cGMP and ISO 9001 compliance including documentation requirements, SOP training, Quality agreements/Quality Directives and routine audits of facility. Wrote technical sections of CMC, BLA and PMA documents for FDA regulatory submissions. Successfully discussed and defended technical issues with FDA auditors, internal and external site inspectors.
Manufacturing
Technical manager for bacterial fermentation, protein purification, cell banking, reagent manufacture and in-process quality control areas. Prepared production schedules based on forecast and inventory supply using material resource planning tools such as 4th Shift and SAP. Supported start-up of manufacturing facilities in Puerto Rico, Switzerland, England, Spain and NJ including transfer of technology to middle management and unskilled labor. Supervised pilot plant to produce materials for clinical studies (Phase 1-3).
Development
Extensive experience in developing and scaling-up protein purification processes for new biopharmaceutical and in-vitro diagnostic products. Very knowledgeable in chromatography, cell/broth separations, DNA, virus and endotoxin removal, protein folding methods, pilot plant bacterial fermentations, reagent manufacturing, cell banking procedures, small molecule dosage forms, clean rooms and analytical characterization. Scaled-up, optimized and tech transferred large-scale process steps to achieve greatest purity, yield and throughput. Author or co-author on eleven patents and publication.
Supervision and Management
Supervised, guided and led staff up to 14 people on two shifts, including B.S., M.S. and Ph.D level scientists in development, manufacturing, validation and compliance activities. Prepared and maintained department budgets to meet overall financial objectives. Developed department goals and executed staff performance reviews.
PROFESSIONAL EXPERIENCE
ASSOCIATE DIRECTOR/QUALITY EXPERT, 2006 to Present NOVARTIS PHARMACEUTICALS, East Hanover, NJ
Technical Research and Development, Quality Assurance Group
Quality; Evaluate quality and regulatory CMC documentation of new small molecule dosage forms (solid, liquid, sterile, inhalation)) used for toxicology and Phase 1-3 clinical studies for compliance with cGMP and FDA guidelines. Department Project Leader for oncology and respiratory projects including API sourcing, drug substance and drug products for human use clinical studies including status control, issuance of Certificates of Analysis and oversight of Quality Agreements. Evaluate and approve procedures for validation including cleaning, analytical methods, technical transfers and process as well as specifications, deviations and change control documents. Manage process investigations and coordinate resolution and follow-up activities. Lead Pre-approval/Inspection Management (PAI) preparation and audits. Review and approve registration stability protocols and development stability reports.
Inspection: Perform audits and inspection of vendors, suppliers and services to evaluate suitability for use by Novartis groups. Evaluate new business prospects for technical and GMP issues by performing due diligence of business capabilities. Oversee compliance activities of drug substance and drug product for solid, liquid, sterile and inhalation dosage forms at external manufacturing sites.
Supervisory: Lead project teams on quality assurance activities for review of documentation associated with the manufacture, testing and release of drug substance and drug product batches. Subject matter expert for biological and sterile manufacturing issues.
GROUP LEADER, 1992 to 2006 ROCHE MOLECULAR SYSTEMS, Branchburg, NJ
Bioprocessing Department, Technical Operations Group
Manufacturing: Leader of group responsible for the batch production of in-vitro diagnostic enzymes (AmpliTaq), kit reagents and nucleic acid controls for the PCR product line. Technical manager for bacterial cell banking, fermentation, protein purification, DNA/RNA and bulk formulation areas conducted in clean room environment. Developed, optimized, and led the technology transfer of new and improved manufacturing processes and analytical procedures. Produced enzymes for Human Genome sequencing project. Member of team directing the design, start-up and validation of new multi-purpose facility.
Quality: Initiated and led validation program for protein manufacturing area. Developed master plan, equipment qualification protocols and process validation strategies. Initiated projects for test method validation of in-process assays to comply with FDA regulations. Led team on adopting quality assurance objectives to achieve compliance including management of process and analytical investigations, CAPA, OOS, SOP training, change control and non-conformances. Project manager for purchase of new process equipment including equipment selection, design, FAT, SAT and start-up. Internal auditor to enforce cGMP and ISO 9001 compliance. Wrote, reviewed and approved CMC submissions for rDNA products. Member of audit team representing department on cGMP and technical issues during FDA, Team Biologics, internal, external site inspections.
Supervisory: Scheduled work assignments for 9 staff scientists. Designed and monitored work to ensure accuracy and efficient job performance. Appointed as Site Radiation Safety officer with responsibility for administering all radioactive work within NRC guidelines.
PRINCIPAL SCIENTIST, 1988 to 1992 JOHNSON & JOHNSON - ORTHO PHARMACEUTICAL, Raritan, NJ
BioProcess Development Department
Development: Led process development team in analyzing process conditions for the purification of Erythropoietin (Procrit) derived from mammalian CHO cells. Implemented critical process changes to better control chromatography separation procedures in the Manufacturing: Technology transfer leader on the start-up of clean room cell culture purification manufacturing area in Puerto Rico. Trained and instructed site personnel on scaled-up purification procedures. Advised and trouble-shoot process failures and variable performance for manufacturing plant in Slough, England. Presented strategies on bioprocess scale-up at InterPhex USA workshop.
Quality: Wrote, reviewed and executed process validation protocols for purification steps. Organized data and wrote final reports. Appointed as liaison for manufacturing issues pertaining to non-conformances, SOP training, investigations and CAPAs for commercial bat...
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