MICHAEL P. DOMENICI
San Francisco,USA
Summary
Accomplished professional with over 40 years of experience in Diagnostic Reagent Manufacturing, Research & Development, and Biopharmaceutical Fields. Known for driving quality assurance, value-added activities, and cost reduction initiatives. Skilled in team building, emphasizing efficiency, communication, and professional growth. Proficient in ISO9000, ICH, EU, FDA regulations, filling & labeling operations, and Good Manufacturing Practices. Results-oriented achiever with proven ability to exceed targets and drive success in fast-paced environments. Combines strategic thinking with hands-on experience to deliver impactful solutions and enhance organizational performance.
Overview
46
46
years of professional experience
Work History
DIRECTOR QUALITY ASSURANCE
Gilead Sciences
03.2023 - Current
- Foster and manage resources and workload balance within a group of Quality professionals to ensure development and commercial programs meet timelines and quality & compliance expectations in an equitable manner.
- Coach and mentor staff to drive independence, development, and performance.
- Review and approve transfer and technical reports for the treatment of Hepatitis D.
- Revise BLA filing and approve risk assessments for complex events.
- Participate in cross functional teams transferring technology to contract manufacturing site.
- Review and approve audit reports for contract sites.
ASSOCIATE DIRECTOR QUALITY ASSURANCE
Gilead Sciences
11.2019 - 03.2023
- Review and approve validation documents for injectable products fill/finish.
- Oversee Contract Manufacturing Sites (CMO), review deviations, change controls and process improvements.
- QPTL for Bulevirtide, oversee BLA filing, incorporating MYR processes under Gilead.
- Responsible for medical device used with Gilead product for administration of drug.
- Quality Assurance Functional Site Lead for contract sites
- Oversee the serialization process for AmBisome product, onsite coordinator at PCI for Gilead
- Perform audits, write risk assessments and assess all compliance observations for each CMO
- Point person for recent FDA CDER inspection at CMO (JHS)
SENIOR MANAGER QUALITY ASSURANCE
Gilead Sciences
10.2014 - 11.2018
- Review and approve manufacturing master batch records, executed batch records, in-process/finished product quality control data for timely disposition of drug product intended for human use
- Prepares lot disposition reports, reviews planned changes, deviations, analytical reports, laboratory investigations, change controls, method and process validation protocols and reports for management review.
- Review and improve existing quality procedure workflows and identify areas of improvement for efficiency. Draft or revise applicable written procedures.
- Interface directly with contract manufacturers, alliance partners and manage quality related issues by leading investigations and identifying corrective actions.
- Present Quality Metrics to Senior Leadership Team on performance of Contract Manufacturing sites
GMP OFFICER
Novartis Corporation
06.2013 - 10.2014
- Responsible for commercial Tobramycin (capsule technology) product release.
- Provides general oversight to operations on the shop floor, supporting operators and support staff as needed to identify and address product quality and compliance issues as they arise.
- Perform random verifications of routine operational requirements, both on a product/batch level as well as on a process level.
- Change Control reviewer and approver for Quality Engineering
QUALITY ASSURANCE TECHNICAL SPECIALIST
Amgen Corporation/Boehringer-Ingelheim, Ben Venue Site
03.2007 - 06.2013
- Review, approve Piping and Instrumentation Drawings for WFI, Clean Steam, Gases and HVAC Systems
- Oversee the Contract Manufacturing of Vectibix Drug Product and Substance
- Perform investigations and corrective actions in the Aseptic Fill and Manufacturing Areas utilizing Trackwise
- Review and approve validation protocols (Clean Steam, WFI and HVAC)
- ISO 5 qualified for Plant Quality Assurance for Fill Finish
- Oversee all “shutdown” activities in fill and manufacturing areas and authored several protocols
- Change Control reviewer and approver for Quality Assurance
- Participated in internal/external audits and regulatory inspections
- Review, approve URS, FAT’s, and Commissioning Documents for Bosch MHI2020 at Ben Venue
MANAGER-DOCUMENTATION AND INVESTIGATIONS
Chiron/Novartis Corporation, Biopharmaceutical Division
07.2005 - 10.2006
- Program manager for the investigation and closure of manufacturing deviations
- Responsible for the review of Filling and Inspection documents
- Improved first time quality from 50% to 90% within the Filling and Inspection areas
- Sponsored and Implemented KAIZEN teams to improve productivity within Inspection area.
- Attended Silver Belt Training, streamlined document review process within Parenteral Operations
MANAGER- VISUAL INSPECTION
Chiron Corporation, Biopharmaceutical Division
07.2003 - 06.2005
- Responsible for the inspection of all parenteral and clinical products manufactured at Chiron Biopharma
- 24-hour operation hired and organized department to inspect 18 million vials/year
- Revised training program and improved inspection process. Planned and promoted training activities related to product quality
- Reduced operator errors and cycle time
- Developed and analyzed data and product specifications to determine present standards and establish proposed quality and reliability expectancy of finished product
- Investigate and close customer complaints
MANAGER - COMPLIANCE AND DOCUMENTATION
Chiron Corporation, Biopharmaceutical Division
07.2000 - 06.2003
- Responsible for filling and finishing operations for the Clinical Manufacturing Facility for Batch Record Review and Discrepancy Reports and Investigations
- Assist with Training and Development of Operators, Supervisors, and Managers ON GMP’s, SOP’s, HVAC Safety and Monthly Area Inspections and Corrective Actions
- Assisted and participated in recent audits of the manufacturing facility
- Revise, streamline, and implement record processes with QA and Manufacturing management
- Collaborate with cross functional groups in order to upgrade, improve, and create more efficient organization and throughput of product through the facilities.
- Closed discrepancy reports that resulted in a savings of $250,000 of Men C Product
- Participate in weekly production meeting with cross-functional groups to ensure timely fill schedules and finishing of product.
- Support and provide back up for Filling and Finishing Managers as needed
- Familiar with the European Agency For The Evaluation Of Medicinal Products (EMEA)
- Member of the Chiron Internal Compliance Audit Team
- Implemented Lock Out/Tag Out Program at Chiron Corporation
MANAGER - PARENTERAL OPERATIONS
Chiron Corporation, Biopharmaceutical Division
11.1998 - 07.2000
- Responsible for managing the filling & lyophilization process of all injectable products
- Manage the activities of all three shifts, which include three supervisors and twenty fill operators
- Streamlined the fill process by improving efficiencies and reducing staff requirements, which resulted in cost savings of $500,000
- Familiar with TL Filler, Bosch Washer, and steam sterilizers
- Coordinated the transfer of Meningitis C Vaccine from Process Development to Parenteral Operations
- Key participant and respondent in recent FDA and UK Medicines Control Agency Audits
- Coordinated and managed the Contract Manufacturing of MedImmune Synagis
MANAGER – FILLING AND LABELING
Chiron Corporation, Blood Testing Division
03.1997 - 11.1998
- Coordinated and managed downstream Filling and Labeling activities for Nucleic Acid Diagnostics, Antigens, Peptides, and Conjugates. Proficient with aseptic filling techniques and operation of Class 100 facilities
- Responsible for the validation of all activities within all Class 100 fill suites
MANAGER - MANUFACTURING DEVELOPMENT
Chiron Corporation, Biopharmaceutical Division
07.1996 - 03.1997
- Managed the manufacturing development processes, implementation, and operations for new and existing products
- Assisted in FDA Audits for subsequent approval of HCRA3 Antigen and RIBA HCV final packaging
- Responsible for the creation and maintenance of procedures and batch production records in accordance with GMPs and Regulatory Compliance
- Developed and maintained all filling and packaging production schedules
- Maintained departmental budget and utilization of capital acquisitions
- Responsible for hiring and management of direct and indirect personnel
PROJECT LEAD - FILTRATION VALIDATION
Syntex/Behring Diagnostics Incorporated
10.1996 - 02.1997
- Developed and executed validation activities for diagnostic reagents, tank design, and product process mapping.
- Created and developed validation protocols for the following filtration areas: Bacterial Challenge Testing, Filter Integrity Testing, Filter Validation, Testing, and Qualification
- Familiar with Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) for Filtration Integrity Testing.
SUPERVISOR - TECHNICAL MANUFACTURING
Syntex Corporation
06.1991 - 10.1996
- Supervised up to ten professionals in the Manufacturing, Filtration, and Quality Testing areas of Emit Reagents for DuPont Co
- Extensive knowledge of process validation for reagent manufacturing
- Created and implemented improvements in manufacturing, through experimental design and data analysis, which resulted in a 50% reduction in direct labor and a reduction of 40% in staffing requirements.
- Implemented human relations’ techniques for Behring Operations Division by direct customer site visits and utilization of professional speakers from various marketing and sales departments.
- Served as Safety Chairperson for the Cupertino Operation Division. Efforts resulted in a 50% reduction in the number of accidents. The frequency, severity, and time loss due to injury was minimized from 25 days to 1 day.
- Proficient with GMPs and ISO9000
CHEMIST I – PRODUCTION/RESEARCH & DEVELOPMENT
Syntex Corporation
03.1979 - 05.1991
- Developed and devised procedures necessary for powder and liquid formulated assays.
- Trained new personnel.
- Created and revised batch records as well as writing procedures for the use of the Karl Fischer Moisture determination instrument.
- Devised polyclonal antibody purification techniques.
- Coordinated the transfer of the Fertility Assay Penetrak from Syva to Serono Co.
- Proficient with the following powder processing equipment: Co-mill, V-blenders, Loss on drying balance and Vacuum dryers
- Participated in analyzing field complaints with the Syva Customer Service Group.
Education
MBA - Accounting And Finance
University of Phoenix
San Francisco01.2004
Bachelor of Science -
University of San Francisco
San Francisco, CA01.1994
Skills
- Relationship building
- Strategic planning
- Verbal and written communication
- Decision-making
- Team management
- Change management
- Negotiation
- Contract and vendor management
- Financial management
- Contract negotiation
- Problem-solving
- Coaching and mentoring
Languages
German
Professional Working
Timeline
DIRECTOR QUALITY ASSURANCE
Gilead Sciences
03.2023 - Current
ASSOCIATE DIRECTOR QUALITY ASSURANCE
Gilead Sciences
11.2019 - 03.2023
SENIOR MANAGER QUALITY ASSURANCE
Gilead Sciences
10.2014 - 11.2018
GMP OFFICER
Novartis Corporation
06.2013 - 10.2014
QUALITY ASSURANCE TECHNICAL SPECIALIST
Amgen Corporation/Boehringer-Ingelheim, Ben Venue Site
03.2007 - 06.2013
MANAGER-DOCUMENTATION AND INVESTIGATIONS
Chiron/Novartis Corporation, Biopharmaceutical Division
07.2005 - 10.2006
MANAGER- VISUAL INSPECTION
Chiron Corporation, Biopharmaceutical Division
07.2003 - 06.2005
MANAGER - COMPLIANCE AND DOCUMENTATION
Chiron Corporation, Biopharmaceutical Division
07.2000 - 06.2003
MANAGER - PARENTERAL OPERATIONS
Chiron Corporation, Biopharmaceutical Division
11.1998 - 07.2000
MANAGER – FILLING AND LABELING
Chiron Corporation, Blood Testing Division
03.1997 - 11.1998
PROJECT LEAD - FILTRATION VALIDATION
Syntex/Behring Diagnostics Incorporated
10.1996 - 02.1997
MANAGER - MANUFACTURING DEVELOPMENT
Chiron Corporation, Biopharmaceutical Division
07.1996 - 03.1997
SUPERVISOR - TECHNICAL MANUFACTURING
Syntex Corporation
06.1991 - 10.1996
CHEMIST I – PRODUCTION/RESEARCH & DEVELOPMENT
Syntex Corporation
03.1979 - 05.1991
MBA - Accounting And Finance
University of Phoenix
Bachelor of Science -
University of San Francisco
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