Montgomery Street, San Francisco, CA94105609 Johnson Ave., 49204, Tulsa, OK
H: (555) 432-1000
C:
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Date of Birth:
India:
:
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Professional Overview
Possess 29+ years of experience in the drug safety/pharmaceutical research industry, including 3 years as a project/technical expert in DSRD, 6 years of supervisory experience in DSRD, at least one year in production with emphasis on microbiology and quality control release testing for Pharmaceutical Production and 27 years of toxicology/ formulation experience, which includes the preparation and delivery of various dosage forms. Experienced in the preparation and quality review of; protocols, batch records, data transfer (including communication with contracted resource organizations), preparation records for pre-clinical studies, authoring standard operating procedures (including member of the Groton DSRD site standard operating procedure committee) as well as sourcing/purchasing of required equipment and raw materials. I am also proficient with the use of many computer systems as well as fully trained in computer system validation. Significant career accomplishments are: the initiation and set up of a formulation department, assisting in the development and validation of a GLP compliant data collection system, and the recipient of a team of the year award for a marketed pharmaceutical. I am currently interested in furthering my career growth within the Pfizer pharmaceutical industry.
Core Qualifications
GLP requirements, Communication, Flexibility, Ability to organize and meet time-frames, Pharmaceutical math and various calculations including concentration and dosage, Ability to meet customer needs. Have the ability to supervise a diverse staff. Computer Skills include; Word Suite including document preparation, spreadsheet, presentation, resource scheduling and computer validation.
LANGUAGES - English
Accomplishments
Significant
career accomplishments are: the initiation and set up of a formulation
department, assisting in the development and validation of a GLP compliant
data collection system, and the recipient of a team of the year award
for a marketed pharmaceutical.
Education
Bachelor's Degree: Management, Expected in April 2011 - University of Phoenix - , GPA: Management
Bachelors of Science: , Expected in 1992 - SUNY PLATTSBURGH STATE - PLATTSBURGH, NY GPA:
Associate Degree: , Expected in - - , GPA:
AAS: Medical Laboratory Technology, Expected in 1986 - SUNY - Canton, NY GPA: Medical Laboratory Technology
Experience
Toxicology Technician, 03/2010 - Current Harris County – Katy, TX,
As a formulation technician, I prepare and also oversee formulation preparations for small molecule, biological, vaccine, diet, capsule, and medical applications along with significant expertise in aseptic manufacturing of injectable dosage forms.
These functions required knowledge of laboratory equipment and procedures as well as the understanding of dosage form uses.
I am the system administrator for the electronic inventory system utilized by the formulation group in Groton.
I communicate with study personnel for my assigned studies or other studies for which I have a role and periodically assist in communications with CRO's when required in support of contract study needs or questions as well as assist in routine investigation and troubleshooting of departmental processes.
I communicate regularly with the quality assurance group to ensure site procedures comply with regulatory requirements.
I am responsible for sourcing materials and ordering materials required by the formulations group.
I have been a member of the Groton DSRD SOP committee since May 2010.
Research Scientist I, 2009 - 03/2010 Danaher – Grand Island, NE,
Biotechnology/Pharmaceuticals I held this position for 15 months prior to transitioning to my current Pfizer technical position.
I was responsible for the preparation of protocols and formulations directions for the preparation of general toxicology, safety pharmacology and reproductive toxicology formulations for in house GLP studies as well as for CRO's.
I was responsible for sourcing required equipment and materials.
I was also the was responsible for setting up and ensuring that required project stability studies were conducted and authored the stability reports for inclusion in study reports.
I was responsible for communications with all on site study directions, project teams and support staff in support of the portfolio needs.
I provided technical oversight for the manufacture of all toxicology formulations.
I Evaluated equipment needs and process variables to ensure formulation preparations were of the highest quality possible.
I Determined quantities of API required to, conduct drug safety studies.
I was also responsible for the scheduling of studies and workloads within the Formulation group.
Scientist II, 2002 - 11/2008 Emd Millipore – Weiterstadt, DE,
Biotechnology/Pharmaceuticals.
Performed current role as a Study Scientist along with the additional role as supervisor of 5 - 11 staff.
I Supervised all personnel assigned to my group as well as assisted with supervision of other staff within my department.
I assured personnel were trained, work priorities were clearly stated, and tasks were assigned efficiently to meet all study timelines.
I met formally with my study group at least biweekly and on an as needed basis.
I was responsible for providing oversight of scheduling activities, performing drug estimate determinations, and for writing protocols and formulation preparation instructions.
Serve as systems administrator for the formulation tracking system and as the group's designated PPP author.
Performed communications with CRO's and supported contract study needs.
Performed site qualification visits in support of formulation capabilities and compliance.
Scientist I, 08/2001 - 12/2002 Thermo Fisher Scientific Inc. – Colorado Springs, CO,
Biotechnology/Pharmaceuticals.
Performed many of the job roles listed in Scientist II position.
Technician III - Technician VI, 08/1987 - 06/2001 Dairy Farmers Of America – Blairsville, GA,
Biotechnology/Pharmaceuticals.
Through my career as a technician I performed routine laboratory activities in Toxicology and formulations.
Key experience with technical aspects of; formulation preparations for small molecule, biological, vaccine, diet, capsule and medical applications along with significant expertise in aseptic manufacturing of intravenous dosage forms.
These functions required knowledge of laboratory equipment and procedures as well as the understanding of dosage form uses.
Assisted in communications with CRO's and supported contract study needs.
I also assisted in several CRO site qualification visits and data transfer meetings.
Laboratory Technician, 09/1986 - 07/1987 Adirondack Medical Center – City, STATE,
After working several months in the healthcare field I then transitioned to the Pharmaceutical field to gain experience in the area of healthcare.
Responsibilities while working at Adirondack Medical Center were bench work rotating between departments with a focus in Hematology and Microbiology.
Upon transitioning to the pharmaceutical field I worked in the area of microbiology and physical testing of over the counter and prescription medications prior to transitioning to the area of toxicology of research pharmaceuticals.
Skills
Good Laboratory Skills, Full knowledge of GLP
requirements, Communication, Flexibility, Ability to organize and meet
time-frames, Pharmaceutical math and various calculations including
concentration and dosage, Ability to meet customer needs. Have the ability to
supervise a diverse staff. Computer Skills include; Word Suite including
document preparation, spreadsheet, presentation, resource scheduling and
computer validation
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