Paul Bemis Email & Phone Number

Compton, CA, US

Waltham, MA, US

Provides strategic leadership and management for the Chromatography & Proteins global manufacturing network's quality organization (six sites). Responsible for developing, implementing and maintaining a robust quality management system to meet regulatory requirements and exceed industry standards. Collaborates closely with senior.

Waltham, MA, US

• Provide strategic direction and management to a staff of approximately 40 quality individuals across three sites in California. Repligen Corporation develops and commercializes bioprocessing technologies and systems.
• Successfully maintain compliance to ISO 9001 for all aspects of the QMS including but not limited to Internal & External audits, Nonconforming Materials, CAPA and Validation systems
• Coordinate multi-site harmonization plans with the Repligen Global QMS system
• Partner with cross-functional stakeholders to develop, implement and conduct training on continuous improvement initiatives that drive Quality programs to ensure maximum productivity
• Advance, implement and monitor Quality programs, policies and procedures to ensure compliance with GxP standards, ISO standards and corporate policies
• Establish and maintain a positive working relationship with customers while managing corrective actions aiding the reduction of complaints

Seal Beach, CA, US

Site Head of Quality for the Seal Beach immunotherapy Manufacturing Facility (IMF) Responsible for all site Quality Assurance, Quality Systems, Compliance and Quality Control Laboratory areas, with a staff of 54.Dendreon is a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy. Dendreon’s flagship product, PROVENGE.

Chestnut Ridge, NY, US

Oversee all quality and compliance functions for the site.

Chestnut Ridge, NY, US

• Oversee quality systems and compliance activities for site. Responsible for key quality systems - Documentation Control, Change Control, Training, Audits, Complaints, Field Alerts and Recalls. Develop and maintain key.
• Implemented ComplianceWire for training program
• Created and Implemented a Train-The-Trainer program and updated the On-The-Job (OJT) training system.
• Implemented MasterControl document management system for SOP’s, Work Instructions, Forms, Protocols and Reports.
• Site representative/team leader in multiple global quality projects: Supplier Quality, Auditor Qualification, Data Integrity, Inspection Readiness, Change Control and Corporate Quality Policies.
• Develop and maintain key quality metrics for the site; Host site Quality Review Board meetings

Chestnut Ridge, NY, US

Responsibility/oversight for review and approval of all production deviations, laboratory deviations and corrective/preventive actions (CAPAs). Manage QA Analytical team. Established a product monitoring program (Product Scorecards) using statistical software (JMP) to trend product performance. Drafted and implemented procedure to outline the program.

Chestnut Ridge, NY, US

• Oversee laboratory operations to insure a smooth transition in department management with no impact to the business. Focus on safety and quality/compliance improvements within the organization.
• Responsible for direct oversight of Quality Control Laboratory operations, with a staff of 2 managers, 4 group leaders and 30 chemists.
• Organized and executed a 5-S (Sort, Straighten, Shine, Standardize and Sustain) activity to improve safety, compliance and efficiency.
• Significantly reduced deviation rate through effective root cause analysis and targeted preventive actions
• Significant reduction in testing backlog through establishing dedicated resources and instruments for high volume products and re-organizing lab instruments, prep work space and supplies for optimum efficiency.
• Implemented SMART-QC software to facilitate gathering and reporting of Key Performance Indicators for the laboratory.

Chestnut Ridge, NY, US

• Successfully transitioned into an ‘individual contributor’ role with no direct reports.
• Responsible for direction, review and approval of all commercial laboratory and production deviation investigations.
• Implemented the ‘Product Scorecard’ program which incorporates the use of statistical software (JMP) to trend product performance over time. Present to management on regular basis.
• Provide hands-on training and oversight for the investigation process to insure effective root cause analysis and targeted, effective preventive actions.
• Successfully presented and defended all investigations reviewed by FDA inspectors during site audit – no 483’s issued related to the investigations or the investigation system.

Tel-Aviv, IL

• Responsible for In-Process Quality Assurance, Label Control/Issuance, Labeling Artwork Review/Approval, Raw Material Disposition, Vendor Management, and Retain Management areas, with a staff of 15, at a solid dosage.
• Provide audit support for all regulatory and partner audits to insure compliance and cGMPs.
• Directed and implemented a risk-based approach for internal auditing of manufacturing, packaging and warehouse operations.
• Site leader for Teva global ‘Right, the First Time’ (RFT) initiative.
• Successfully represented the quality assurance department as the Subject Matter Expert (SME) for Global SAP implementation. Intimately involved with testing cycles, fielding questions, providing guidance and training.
• Identified affected documents and completed necessary updates (SOP's, Forms, Work Instructions, etc) for SAP go-live.

US

• As a result of diligence, a mentoring management style and a very cooperative work ethic, led the QA Raw Materials group to far exceed all performance goals. Successfully managed QA support for go-live of a new.
• Provided excellent service to all customers, including key projects such as SAP implementation, RFID pilot, and various projects related to manufacturing of new products at the site.
• Effectively led the Raw Materials group in achieving a 100% disposition of all raw materials within 2 business days of file receipt for the last 2 years---far exceeding the established goal of 80%.
• Ensured that all raw material and component specifications were current and in compliance with both vendor commitments and Cephalon requirements.
• Completely designed and set up the new label control areas in building 700. Managed all aspects of the label cage including ordering and installation of all necessary equipment. Successfully completed all necessary.

US

• Quickly developed skills necessary to take a leading role within several keys areas of the department such as: Review of raw material files and disposition of raw materials, conducting effective investigations and.
• Cross-trained in the finished products section of QA in areas such as finished product investigations, in-process inspections, and batch record review.
• Reduced the number of deviations for preprint lidding end of lot reconciliation as well as the average variance for preprint lidding EOL from 6.04% (Jan. – Apr. 2004) to 2.65% (May - Oct.2004).
• Successfully closed 95 open deviation reports for 2003 (91 investigations closed in the first 3 months of 2004).
• Effectively managed the 2004 deviation reports (97.56% completed and 89.76% closed as of Oct.2004).

Taught English to students of all age levels and abilities ranging in age from kindergarten through college as well as business professionals. Developed curriculum and interactive class exercises that were age and ability appropriate. Key Achievements:Designed curriculum appropriate for each class level from kindergarten thru college as well as materials.

Assisted the Principal Investigator in the design, implementation and performance of new protocols and procedures as well as the modification of existing techniques for chromatographic and mass spectrometry instruments in a forensic research laboratory. Made advanced statistical calculations, analyzed and interpreted data and prepared reports summarizing.

Logan, Utah, US

Supervised the care of research animals in a Biohazard Safety Level 3 facility (BSL-3); performed animal surgery and collected animal tissues and specimens for laboratory analysis. Conferred with Principal Investigator regarding the procedures and techniques to be followed in conducting research and recommended modifications as needed. Used spreadsheet.

Master Of Business Administration (M.B.A.)

Bachelor Of Science (Bs), Wildlife, Fish And Wildlands Science And Management

Pre-Veterinary Studies