Contact Us

505-207-7740

U.S. Cit, // Currently MO // will relocate
B.A. Chemistry, University of Kansas, PC competent in BASIC, DOS, MS applications and HTML.
Non-sterile oral and topical preparations, biological filling, sterile-aseptic products, ophthalmics, ALP form/fill/seal packing operations.
Logistics, manufacturing, GMP compliance and product development, preparing CMC documentation, negotiating contractual supply agreements, scheduling production and logistics, and resolving product related QA/QC issues, installation, validation and re-commissioning of idled pharmaceutical manufacturing plant, all phases of raw material and finished product testing, QA/QC issues, developing and approving raw material specifications, documenting manufacturing processes as well as determining finished product specifications.

WORK HISTORY

February 2015 to Present: ACTING VICE PRESIDENT, MANUFACTURING:
Responsible for logistics, manufacturing, GMP compliance and product development manufacturing for start-up firm developing nonsterile oral and topical preparations. Responsibilities include identifying and qualifying contract manufacturing and testing providers, preparing CMC documentation, negotiating contractual supply agreements, scheduling production and logistics, and resolving product related QA/QC issues.
Solely responsible for developing and approving raw material specifications, documenting manufacturing processes as well as determining finished product specifications. Responsible for fulfilling commercial deliveries, enrolling stability samples in test programs and complete process validation and packaging designs in anticipation of FDA requirements.
Support new drug applications via API sourcing, establishing specifications, documenting manufacturing processes and determining finished product specifications. Responsible for manufacturing stability batches, enrolling stability samples in test programs and complete process validation and packaging designs in anticipation of NDA approval and product launch.

September 2012 to December 2014: ACTING DIRECTOR QA/QC
Responsible for installation, validation and re-commissioning of idled pharmaceutical manufacturing plant. Authored all validation documents, SOP’s and batch record, established document control procedures and retention. Hired and trained all departmental employees and training of operating personnel. FDA point of contact for preapproval inspection(s).

Independent Contractor: January 2009 to Present
Domestic and international assignments regarding cGMP compliance, FDA mediation and remediation, API manufacturing, process validations, document preparation and various types of FDA submissions. Locations included high risk travel on several continents.

January 2001 to December 2008: DIVISION VICE PRESIDENT, MANUFACTURING:
January 2001 to December 2008 responsible for logistics, manufacturing, GMP compliance and product development manufacturing for pharmaceutical division. Inc. Responsibilities include identifying and qualifying contract manufacturing and testing providers, negotiating contractual supply agreements, scheduling production and logistics, and resolving product related QA/QC issues.
Coordinates manufacturing aspects of pharmaceutical new drug applications such as raw material sourcing, establishing specifications, documenting manufacturing processes and determining finished product specifications. Responsible for manufacturing stability batches, enrolling stability samples in test programs and completing pre-submission manufacturing validations such as AET, aseptic filter qualification, container closure, cleaning validations, assembling aseptic process validation (APV) package, etc.

January 1991 to January 2001: DIRECTOR, PHARMACEUTICAL OPERATIONS:
January 2000 dual responsibility for pharmaceutical operations and sterile biological production at two sites. Coordinated process validation, start-up of new biological filling facilities and significantly improved aseptic operations. Directed international pharmaceutical product transfers from German to USA manufacturing sites.
PLANT MANAGER: March 1993 responsible for 120 personnel and operation of KS facility including Quality Control, Production, Plant Engineering and Environmental Hygiene functions. Site engaged in the production of sterile pharmaceutical injectable, non-sterile liquid and solid pharmaceutical dosage forms. Responsible for FDA, EPA, and OSHA regulatory compliance, budget setting and management of $9,000,000 annual expenditure. No adverse FDA findings or actions during tenure, awarded two OSHA exemptions for regulatory compliance and successfully completed multiple environmental inspections.
DIRECTOR, PRODUCTION: January 1991 responsible for all pharmaceutical production at the Elwood, KS site. Established new parenteral production suites including approval of Class 100 clean room design, construction and validation. Authored and/or approved operational validation protocols, SOP’s and batch records, qualified aseptic operations and obtained FDA recertification for GMP compliance February, 1992.

Ophthalmics: May, 1989 to January, 1991 UNIT DOSE BUSINESS MANAGER:
Responsible for installation, validation and operation of 5 ALP form/fill/seal machines and packing operations. Authored validation documents, SOP’s and batch records. Hired and trained all departmental employees including 3 supervisors, 4 maintenance mechanics, logistics and 20 operating personnel. Production beginning October, 1989 totaled 100,000,000 sterile unit dosages by January, 1991.

1979 to 1989: Same employer
February, 1987 to May, 1989: STERILE FILLING MANAGER:
Responsible for operation of 9 aseptic filling lines, equipment/component preparation and product inspection. Directed 110 employees and production of approximately 310,000,000 sterile injectable dosages of vials, ampule, large and small volume prefilled syringes.

January, 1979 to February, 1987 SECTION SUPERVISOR/SUPERVISOR/CHEMIST: in diverse sterile injectable plant. Responsible for all phases of production including formulating, equipment/component preparation, aseptic filling, lyophilization, terminal sterilization, inspection and packing of approximately 250,000,000 injectable dosages of vials, ampules and syringes. Improved lyophilization performance, organized technical presentations regarding steam sterilization and lyophilization. Significantly reduced bulk product losses in formulation. Experienced in conducting all phases of raw material and finished product testing.

FOR FULL RESUME CALL 505-207-7740 or email Jobs@pharmaboard.com