Project Manager Engineer

Angela Elliott 510-***-****

[pic]

**** ****** ***, ****** ******, CA 94546

**********@*****.***

OBJECTIVE

Obtain a management position within the scientific community where I can

use my education and experience to achieve corporate goals of the company.

ACCOMPLISHMENTS

. Maintained Compliance of 2 Final Product Filling Facilities with

Limited Staff

I served as Manager of Filling Department for approximately two years. A

new Manufacturing Filling Facility was opened, and due to high product

demand, the closure of the first Facility was delayed. The company had a

hiring freeze prohibiting the hiring of additional employees or

contractors. Thus I had to ensure compliance of both facilities with

limited staff. Ensuring the compliance of the validated state required

performing revalidation testing at the industry required frequency and

ensuring the sterility compliance of the aseptic manufacturing facility via

the performance of NLT 2 media fills for the year in both facilities.

These activities to ensure compliance had to occur while the facility was

producing product. Thus there was a lot of coordination and working around

the clock. The action plan included cross training of scientist from other

process streams, modifying work schedules to meet product shipment due

dates, and personally executing many of test functions to ensure that the

Final Product Manufacturing equipment or Processes remained in its

qualified state.

. Developed Product Device Testing

On 3 separate occasions a shipment of device components from our vendor did

not pass sterility testing. In order to secure the launch of a new device,

an in process control needed to be put in place onsite to verify the

integrity of the components before use in production. The development and

implantation of the in process control was accomplished within a very

aggressive time period allowing for the launch of the new product device.

The device had to pass container closure integrity testing. The device had

to be in compliance with the sterility requirements of injectable drug

devices. The device type for the injectable drug now accounts for 70% of

sales for the Pharmaceutical division.

. Developed Assay to detect Chromosomal Aberrations

As a member of the Lawrence Livermore National Laboratory Research team,

worked with a sister lab in China to develop a method for accurately

identifying chromosomal aberrations. The identification method was

Fluorescent in Situ Hybridization (FISH). The FISH method was a quick way

for researchers and clinicians to evaluate the radiation dosage levels

appropriate to treat expecting mothers that had cancer. The dosage level

had to be so precise as to be destructive the cancerous cells without being

detrimental to the unborn fetus.

WORK EXPERIENCE

. Senior Manger Process Validation, Bayer Health Care, Berkeley, CA

2010 - Present

Provide validation strategies with respect to regulatory requirements and

commitments. Responsible for generating Validation related TRDs in CTD

Format (Module 3). Work with Global Biologics Department to

transfer/leverage small scale studies to full Process Validation projects.

Plan and assign work to staff based on project deadlines with input from

customers, such as QA CMC Specialists, Project Mangers, and Regulatory

Affairs. Present during regulatory inspections and draft observation

responses that relate to the compliance of the entire manufacturing process

(API, final product, packaging and shipping). Review and /or revise

documents during license renewals. Prioritize validation activities based

on overall plans and resource availability. Develop and control the

validation budget, including the transfer of expenses to projects and AFEs

as required. Maintain budget goals and present to senior VPs and Finance

Group at quarterly budget meeting. Serve as the authority in compliance

with domestic and international regulations.

. Validation Manager, Bayer Health Care, Berkeley, CA

2008- 2010

Coordinated, supervised, and directed all validation activities for

processes, equipment and utilities associated with new, modified or

existing facilities onsite. I managed 6 full time scientists and 7

contractors. I provided validation strategies with respect to regulatory

requirements and commitments. Prioritized validation activities based on

overall plans and resource availability.

. Scientist: Bayer Health Care, LLC, Berkeley, CA

2005 - 2008

Generated and executed protocols. Interpreted data and wrote final

reports. Reviewed and generated discrepancy reports, SOPs, Change Control

Requests (CCRs), and Regulatory agency documents. I served on cross-

functional project teams as the validation representative.

. Eight Count Staffing and Training Center, Emeryville, CA

2003 - 2005

As owner of Eight Count Staffing and Training Center, I spearheaded all

aspects of the business; inclusive of teaching group exercise classes,

hiring personnel and training new instructors. I also included marketed

and sold services to local health clubs and corporate fitness centers

(e.g., Club One, Clif Bar, YMCA). I developed informational brochures and

a company website. Conducted market research to identify competitors and

set pricing. Eight Count Staffing turned a profit within 4 months due the

use of contractors and a partnership with YMCA.

. Project Management - Contractor, Genentech, Vacaville, CA

1997-2003

As the Project Manager, I led the establishment and maintenance of project

scope, budget, timeline and resource requirements for various cross-

functional projects at the Genentech Manufacturing Facility. I provided

leadership to subcontractors for various interdisciplinary projects

relating to the startup of the facility.

PUBLISHED WORKS/AWARDS

Published "Chromosome Translocations: A Biomarker for Retrospective

Biodosimetry" A fast and reliable method to detect radiation exposure.

(12/97)

Selected by Bayer Board of Directors to attend Bayer Leadership Program in

Pittsburgh, PA. Selection to this program acknowledges successful work

performed and identifies strong and enlightened leaders to meet future

business goals. (12/09)

EDUCATION

12/2007 Master of Business Administration, Mills College, Oakland,

CA.

5/1996 Bachelor of Science, University of California, Biology,

Berkeley, CA.

PROFESSIONAL SKILLS

Quality Engineer Tool: Six Sigma and Lean and Black Belt

Negotiation Tools: Shell Negotiation and the Seven Elements Plans

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