KRISTIN M. MORENO

ELBURN, IL 847-***-**** ad38h8@r.postjobfree.com

RESEARCH & DEVELOPMENT MICROBIOLOGIST

PROFESSIONAL SUMMARY

A successful, published and proven Project Manager, Microbiologist and Team Leader in Microbiology and Quality Management. A professional at research, product development, monitoring, auditing an organization’s FDA, USP, GLP, cGMP, ISO and Programs and Quality Management systems. I am in search of a full-time role where I will add value to the Quality, Regulatory and Microbiological areas in an organization.

AREAS OF EXPERTISE

New Product R&D

Project Management

Sterile Product

Team Leadership

Aseptic Manufacturing

ISO

Adobe, LRC, PS

Microsoft Office

Regulatory Affairs

FDA USDA OSHA

Quality Standards

Apple OS

Regulatory Compliance

Method Development

Laboratory Validation

Training

CAREER HIGHLIGHTS

New Product Development: Successfully developed new antineoplastic albumin stabilized nanoparticle formulation of paclitaxel methodology for microbiology and sterile filtration production and received FDA product approval.

Method Development: Saved more than $500,000 in raw material cost for the formulation generic antineoplastic drugs.

Collaboration: Created interdepartmental teams to efficiently screen, test, validate and submit abbreviated new drug applications for generic parenteral drugs all while following domestic and foreign regulatory affairs.

Compliance and Audits: Established strong management of cGMP, GMP and GLP quality standards. 21 CFR Part 11

PROFESSIONAL EXPERIENCE

Independent, Self Employed, Elburn, IL February 2004 – Present

Freelance development consultant for individual clients with the goal of streamlining costs, budgeting, procedures and day to day activities. Clients include food and product manufacturing, pharmaceutical, health insurance and club sports.

Project managed client teams to assure efficient production of food manufacturing facilities. Developed HACCP and SOP for clients while saving operating costs.

Consulted with pharmaceutical company clients. Wrote and submitted Abbreviated New Drug Applications and New Drug Applications to the FDA. Analyzed and authored microbiological procedures and practices. Wrote Standard Operating Procedures. Investigated microbial outbreaks and analyzed hazard analysis. Supported pharmaceutical clients under FDA review.

Independently designed sports photography. Established personal website for distribution and sales of high-quality action photography of sports teams and individuals. Created college recruitment videos for collegiate athletes.

Custom photography specializing in youth through college athletics.

Photograph indoor and outdoor sports isolating athlete, team and their successes.

Optimized college recruitment and hype sports videos, yearbook photos, and personal action athlete photos.

PROFESSIONAL EXPERIENCE CONTINUED

New Product Development Microbiologist, Supervisor, American Pharmaceutical Partners, Melrose Park, IL June 1999 – February 2004

Spearheaded new drug development project management team with 6-12 direct personnel. Collaborated with Regulatory Affairs and other drug development research departments to develop ANDA and NDA parenteral drug patents. Supervised sterile manufacture of parenteral products.

Managed 12-15 projects concurrently while overseeing development and production of new sterile parenteral drug products.

Led project management teams for each new product in development.

Increased R&D lab production by 50% by empowering scientist input and integrating systems to navigate budget deficits.

Developed methods for microbiological analyses and production of parenteral drugs while upholding USP criteria. Coordinated, validated and tested raw, in-process and finished product of parenteral drugs.

Wrote and supported projects such as Bacterial Filter Retention studies and Antimicrobial Effectiveness Validation.

Reviewed protocol data from laboratories, outside testing facilities and foreign company protocols to ensure accuracy and compliance. Reviewed, updated and wrote Standard Operating Procedures. Ensured public heath by controlling the efficacy and safety of products.

Maintained microbiological organisms, methodology and reports. Investigated production and laboratory incident reports. Performed employee training.

Publications: Authored 12+ microbiological ANDAs and one NDA, all FDA approved.

Successfully completed internal and outside laboratory audits to assure FDA, USP, and GLP compliance.

Investigated and resolved FDA 483 inquires and responses with no further FDA action required.

Instituted programs to ensure efficient and effective compliance with ISO regulations following cGMP and GLP.

Microbiologist, R & F Laboratories, West Chicago, IL August 1996 – June 1999

Developed research studies for medical, pharmaceutical, food, industrial and chemical clients. Performed routine microbiological tests on client products. Presented research and test findings to corporate clients. Performed case studies on site. Had the distinct honor to work under Dr. Lawrence Restaino and Dr. Elon Frampton in researching new isolation techniques, plating media, microbiological method development and pathology.

Performed all microbiological analyses utilizing USDA/FSIS, FDA, BAM, and AOAC methodologies. Isolated and typed all microorganisms and pathologies. Project managed Microbial Challenge studies, Shelf Life studies, GLP’s and GMP’s and Research and Development studies. Reviewed and presented all data to clients, USDA and FDA.

Wrote SOP for R&F Laboratories and clients. Customized and maintained reporting, communication and compliance. Identified critical control points for manufacturing clients. Trained and supervised 5 lab technicians.

Publications: A Chromogenic Plating Medium for Isolating Escherichia coli 0157:H7., Efficacy of Chromocult Agar for Coliform and Escherichia coli Detection in Foods.

Quality Control Microbiologist, Supervisor, Capitol Wholesale Meats, Chicago, IL July 1995 – August 1996

Supervised and managed Quality Control and Microbiology departments at meat processing facility. Hired, supervised, trained and reviewed 5 QC technicians. Performed all microbiological methodologies on raw, in-process and final products.

Performed microbiological and chemical analyses and initiated sanitation pre-op inspections. Maintained USDA compliance, nutritional and child nutritional labeling. Wrote SOP for QA, QC and Sanitation Departments. Directly reported to owner and production director. Filed reports with on-site USDA inspector.

Developed Sensory and Case Cutting sessions for production. Trained personnel and maintained compliance with OSHA standards and Hazard Analysis of Critical Control Points.

EDUCATION

Bachelor of Science, Illinois State University, Normal, IL

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