Manager Manufacturing
Resume:
Wilhelm Dwyer
Daly City, Ca. *4015
*********@*******.***
Experience:
Solstice Neurosciences, Inc. South San Francisco, Ca. - Senior
Manufacturing Associate (07/04 - Present)
Primary responsibilities:
. Reviewed and audited batch production records for FDA, EU
regulatory agencies
. Prepared product by process of fermentation, recovery,
purification, and dilute bulk
. Lead associate responsible for all areas of manufacturing
production
. Performed analytical testing and sampling.
. Followed strict cGMP operating procedures while in class 10,000,
and 100,000 environments
. Ensured the safe production and delivery of manufactured drug
product
o Worked closely with other cross functional departments to
attain compliance
. Actively and successfully assisted and performed in regulatory
inspections with FDA, EU, CDC, and various Asian governmental
agencies
. Created, established, implemented and executed manufacturing
SOP's
. Performed on site inspections of manufacturing plant to attain
compliance
Other related duties:
. Assisted and performed Quality Control in-process sampling
. Assisted Supply Chain and Materials Management with product
shipment and compliance
. Served as a liaison for the Manufacturing/Facilities group
. Served as a liaison to the Environmental Health and Safety
manager. Assisted EH&S department with the timely maintenance
and troubleshooting of safety equipment and trained associates
in the use of safety equipment
. Assisted EH&S in maintaining compliance with all manufacturing
related activities and equipment
. Perform CAPA's and FUA's for deviation investigation and
resolution
. Performed Validation of fermentor and Gettinge and Steris-Finn
Aqua autoclave systems, and MFCS, UFDF - IQ, OQ, PQ.
. Assisted and performed engineering related duties for the
Engineering department
Process Improvements:
. Located, implemented and facilitated the manufacturing team to
create a data acquisition program to monitor and record
bioreactor process. Implemented and executed the use of a Multi
Fermentor Control System (MFCS), trained associates in the use
of the MFCS
. Located, implemented, and facilitated a new Ultra Filtration
System unit for the improvement of recovery operations. Trained
and qualified associates in the use of the UFDF
. Located, implemented, performed setup and training
procedure/protocol of new Integrity testing devices
Acquired skills
. Strong knowledge and experience with FDA, EU, PMDA Japan, and
KFDA
. Dangerous goods shipment training: IATA, Ground & Air Shipments
of UN3373 Biological Substance, Category B
Hillside Autohaus, LLC, Colma, Ca. - Operations Manager (04/11 - 7/14)
Logistics:
. Located, negotiated and secured business location for repair
operations.
. Successfully negotiated lease terms with Property Manager
. Negotiated with vendors and supplier regarding purchasing of
mechanical equipment, office equipment and established new
accounts with product vendors and suppliers.
. Performed new hire interviews and payroll services.
. Established and executed the following:
o Banking and Payroll system
o Accounts Receivable
o Accounts Payable
o Company guidelines and bylaws
. Performed IT related functions:
o Secured and implemented World Wide Web address and Web
server
o Wireless computer system
o Wireless diagnostic equipment and printers
o Email creation and password setup and maintenance
Leadership:
. Participated in management team process to develop vision and
mission statements.
. Human Resources
o Payroll
o Timecard
. Employee conflict resolution
o Served as liaison between management and employees to
perform conflict resolution
. Accounting and administrative duties
. Financial budgeting and forecasting
o Successfully trimmed initial equipment related debt down
from a 5 year term to 3 years
o Attained and secured new accounts
o Increased revenue and sales flow
o Performed financial cost saving measures
. Maintained a compliant facility
lan Pharmaceutical South San Francisco, Ca - Lead Manufacturing Associate
(04/02 - 07/04)
Primary responsibilities:
. Preparation, set-up and operation of the fermentor system.
. Media preparation
. Maintained a clean and compliant production facility
. Annual batch record and SOP review and revisions
. Lead trainer for all manufacturing associates.
. Served as a liaison to the Environmental Health and Safety
department to ensure safety and compliance.
. Assisted materials management with the timely distribution of:
o Raw materials for production
o Hard goods for production
o Bulk shipment
. Assisted in facility maintenance projects
. Performed equipment validation procedures for all manufacturing
process equipment
Kaiser Permanente, Redwood City, Ca. - Pharmacy clerk (01/97 - 08/99)
Primary responsibilities:
. Assist clients with the proper receipt of prescribed medicine
. Received, processed, and performed data entry on prescription
refill requests
. Assisted and proactively helped clients with the troubleshooting
of lost or mislabeled prescriptions
. Performed basic accounting
. Assisted in routine pharmacy maintenance duties.
Education:
Golden Gate University - Undergraduate Business Management, Graduation
Spring 2016
City College San Francisco - Associate in Science
Archbishop Riordan High School - Diploma, College Preparatory Classes
Certificates and Achievements:
. IATA Dangerous goods, Category A & B shipment certified
. Certified Clean room Technician
. Basic CPR and First Aid certification
. ASE Refrigerant Recovery and Recycling certification
References: Available upon request
Contact this candidate