ANTHONY D. HAYES

**** ******** **** •SAN ANTONIO, TX 78249

PHONE: 210-***-**** • EMAIL: abgfqe@r.postjobfree.com

OBJECTIVE

A PMP certified project manager attempting to obtain a challenging management position that will

utilize my strong interpersonal, organizational, problem solving and leadership skills.

EMPLOYMENT

BOEHRINGER -INGELHEIM, BEN VENUE FACILITY- BEDFORD, OHIO 2009-2012

Sr. Project Manager (2009-2012)

Lead and manage global cross-functional project teams for generic and branded

parenteral products. Manage projects from conception to commercial launch. Manage

projects for humans and animals. Manage remediation projects for facilities and products.

Manage process improvements using lean six sigma tools. Develop and manage project

budgets. Provide business analysis, business process mapping and technical design to

improve the development and launch of new products. Managed third party contractors.

Filing CBE, ANDA, IND, NDA and sNDA submissions. Host clients during site visits.

Managed, developed and mentored junior Project Managers.

• Lead team in establishing a stage gate process for drug development

• Developed drug process development training guide for Project Managers

KV PHARMACEUTICAL – ST. LOUIS, MISSOURI 2007-2009

Sr. Project Manager (2008-2009)

Lead five cross-functional project teams within the Sustainable Compliance Program

while the company was under a Consent Decree. Coordinated remediation activities of

four facilities and one product to ensure cGMP Compliance. This included facility

modifications, product and process improvements. Manage process improvements using

lean six sigma tools. Managed project budgets. Managed, developed and mentored junior

Project Managers.

Project Manager (2007-2008)

Lead and managed global cross-functional project teams for both branded and generic

semi-solid, capsule and tablet products. Organizing and executing new product

development from concept to commercial launch. Managed project budgets.

Managed third party contractors. Filing CBE, ANDA, IND and NDA submissions.

• 3 ANDA Submissions in 1 month

• Recognized in October 2007 for “Outstanding Accomplishments” in the Scientific

Affairs department

• Lead team in establishing project selection process for generic products

MERIDIAN MEDICAL TECHNOLOGIES – ST. LOUIS, MISSOURI 1999-2007

Project Manager (2003 – 2007)

Team lead in the development of new medical device products, line extensions and process

improvements. Host clients during site visits. Manage process improvements using lean

six sigma tools. Execute formulation, filling, packaging and validation studies for new

parenteral products. Write and perform product compatibility and mixing studies. Define project

requirements and timelines to ensure timely completion of company defined goals. Develop and

monitor project budgets. Implement specifications, protocols and final reports consistent with

project requirements. Write protocols for formulation, filling, inspection and packaging

departments. Investigate process failures. Filed NDA submissions.

• Team lead for a terminally sterilized migraine drug

• Applied Lean Manufacturing tools to provide efficient flow of components

into the sterile processing building and product out of the sterile processing

building.

• Obtained Green Belt Certification

Sterile Product Manufacturing Senior Supervisor (2000-2003)

Oversaw the manufacturing of parenteral drugs from component/equipment prep to packaging.

Created and/or modified SOP’s to reflect new processes or improvements. Wrote and reviewed

batch records. Investigated and wrote non-conformance reports (NCR’s). Trained, evaluated and

motivated employees. Conducted weekly departmental meetings. Interfaced with clients during

the manufacturing of their product. Managed 2 junior supervisors and 35 union employees.

Collaborated in the execution of factory and site acceptance tests for new equipment.

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Assisted the validation department in performance installation and operational

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qualifications.

• Point person for the manufacturing area during FDA audits.

Ensured that all aspects of manufacturing followed cGMP guidelines.

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• Interfaced with vendors to provide effective process improvements.

• Worked in partnership with a cross-functional team in order to reduce the EpiPen glass defect

rate.

• Member of the Aseptic Processing Area team whose responsibilities were to identify and correct

issues within the aseptic core.

• Setup training program for mechanics and operators

Sterile Product Manufacturing Supervisor (1999-2000)

Oversaw the filling of parenteral drugs. Created and/or modified SOP’s to reflect new

processes or improvements. Wrote and reviewed batch records. Investigated and wrote

non-conformance reports (NCR’s). Trained, evaluated and motivated employees.

Conducted weekly departmental meetings. Interfaced with clients during the

manufacturing of their product. Managed 35 direct reports.

EDUCATION

Master of Business Administration Degree

(Marketing Concentration) - obtained in 2000

Webster University - St. Louis, Missouri

Bachelor of Science Degree, Biological Sciences - obtained in 1997

Illinois State University - Normal, Illinois

CERTIFICATIONS

PMP

Green Belt

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