Quality Control Manager

BRIAN WEISS

Bridgewater, NJ *****

908-***-**** ************@*****.***

SUMMARY

Extensive experience in validation, manufacturing and engineering for FDA regulated products within a GMP

environment. Recognized for success in areas of personnel management and project coordination with

excellent intrapersonal, multitasking and presentation skills.

PROFESSIONAL EXPERIENCE

ROCHE MOLECULAR SYSTEMS, Branchburg, NJ 1988-2014

Validation Manager, Validation Services and Support (2005 – 2014)

• Supervision, training and delegation of validation projects for employees and contractors

• Authoring and approving validation documents for process validation, cleaning validation, master

validation plans, new supplier qualification, and equipment qualification

• Gap analysis of existing manufacturing procedures and implementation of improved processes

• Validation of new products through technology transfer and contract manufacturing

• Design of pre-validation experiments, statistical process control (SPC), risk assessment (FMEA) and

root cause analysis

• Member of cross functional team to oversee deviations, non-conformances, investigation reports and

CAPA and responsible for justification of validation strategy for audits and inspections

Manufacturing Manager, Production (1999 – 2005)

• Management of production personal responsible for commercial manufacturing

• Process development and scale up of new R&D processes to full scale production

• Authoring and reviewing batch records and associated SOPs for large scale production

• Management of technical operations sub-group for troubleshooting production problems

• Process improvement to allow for increased efficiency and decreased cost

• Coordination and management of training programs for GMP compliance and operator safety

• Process monitoring through trend analysis and establishment of specifications

Principal Scientist, Engineering Support (1996 – 1999)

• Design, purchase and implementation of capital equipment for scale up of bulk manufacturing and

filling/packaging

• Evaluation of new technology for acquisition and evaluation of OEM vendors for the outsourcing of

bulk production, quality control and filling/packaging

• Coordination of Corporate Engineering and outside contractors during installation and alteration of in

house utilities and systems such as HVAC, distilled water and environmental control

• Design and supervision of laboratory construction and renovation in Production Suite

• Supervision of preventive maintenance program for all production equipment

Senior Scientist, Production (1991 – 1996)

• Supervision of production staff responsible for PCR Bulk Reagents in clean room environments

• Coordination of daily laboratory activities including production scheduling and issue resolution

• Writing batch records, SOPs and investigation reports in accordance with cGMP

• Review and approval of completed batch records, calibration documents and training logs

• Supervision of inventory control system involving the storage, issue and destruction of all production

raw materials

BRIAN WEISS

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ROCHE MOLECULAR SYSTEMS, Branchburg, NJ

Scientist, Process Development (1988 – 1991)

• Production, scale up, troubleshooting and testing of Hepatitis EIA product line

• Development of large scale polystyrene bead coating apparatus

• Scale up of Drugs of Abuse controls for Cobas X

• Antibody screening for Therapeutic Drug Monitoring product line using Cobas FARA/MIRA

IMMUNOMEDICS INC., Newark, NJ 1987 – 1988

Scientist, Research and Development

• R & D of monoclonal antibody diagnostic products from concept to launch

• Development of EIAs for HAMA (human anti-mouse antibody) and CEA

• Evaluation of prototypes and products for acquisition

• Writing research directions and QC directions for raw materials, components and kits

• Organization, compilation and evaluation of clinical trial data

• Maintenance of stability for development products

• Writing of package insert and 510(K)

WARNER LAMBERT COMPANY, Diagnostics Division, Morris Plains, NJ 1983 – 1987

Biochemistry Supervisor, Quality Control (1985 – 1987)

• Supervision of staff responsible for the testing of clinical chemistry products and serum controls

• Evaluation and approval of data required for raw material, component and kit release

• Using in process data to calculate batch concentration and provide manufacturing with the necessary

adjustments

• Initiation and supervision of stability programs for components and kits

• Product troubleshooting by trend analysis of historical data

Analyst, Quality Control (1983 – 1985)

• Generation of QC test data from diagnostic kits, components and controls

• Raw material chemical analysis in accordance with USP using AA, IR, UV/VIS and Karl Fisher

• Exclusively responsible for all immunochemical testing related to EIA product line

SOMERSET MEDICAL CENTER, Somerville, NJ 1982 – 1983

Medical Technologist, Hematology, Chemistry, Blood Bank

• Performance of automated and manual testing on patient specimens to determine the diagnosis and

treatment of disease

• Maintenance, calibration and troubleshooting of clinical instrumentation

• Supervision and instruction of medical technology students

EDUCATION

M.S. Biochemistry, Fairleigh Dickinson University, Teaneck, New Jersey

B.S. Medical Technology, Kean University, Union, New Jersey

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