Nancy Rodgers Email & Phone Number

Richardson, Texas, United States

Phoenix, Arizona Area

Phoenix, Arizona Area

Responsible for monitoring the clinic processes to ensure quality and compliance withe SOPs and study protocols.• Review protocols and paperwork prior to study initiation.• Participate in pre-study and site initiation meetings.• Conduct audits of clinical study files, data and procedures for protocol, SOP, and GCP/ICH compliance.• Carry out in-clinic audits and observe consenting process, general study flow and procedures at each step, product distribution and usage instructions.• Responsible for test material receipt and return procedures.• Act as primary liaison to report writers.

Management• Deliver innovative, high quality and cost effective products, for the Dial, Tone and Right Guard brands.• Led a diverse team of product development scientists with a focus on employee empowerment, development and mentoring.• Close collaboration with Marketing to ensure successful product launches.• Drive brand strategy and develop an innovation pipeline.• Presented new product launches to customers.• Stay up to date on the latest technologies, trends and consumer insights.• Led the North American formulation and claims testing of a new global brand.• Integrated newly acquired companies into Henkel processes.Clinical• Led in-house clinical studies using the HCPHW method.• Sub-investigator on Phase II clinical studies.• Collaborated in developing in-house clinical methods to support new product claims.• Knowledgeable in LCAT, deodorancy, antiperspirant sweat studies, repeat hand wash, HCPHW and cup scrub.• Developed questions and guidance documents for focus groups.• Wrote qualification protocols (IQ/OQ/PQ) that met FDA requirements for validation of new equipment.Quality• Monitored drug product stability program.• Ensure Change Control Management of changes to drug products.• Increased “right the first time” manufacturing by leading OOS and deviation investigations, determining root cause and implementing corrective actions.• Implemented equipment calibration and monitoring programs and represented R&D in audits that helped achieve ISO certification and recertification.• Achieved a 75% reduction of non-conforming material reports (NCMRs).• Use of electronic CAPA program.• Presented data and information for an FDA 483 letter and implemented corrective actions that addresses the auditors concerns and closed out the findings.Achievements and Training:• 2 Issued Patents• 11 Peer Reviewed Scientific Publications• GMP, GLP and GCP Training

• Led the formulation and development of liquid hand soaps, hand sanitizers and lotions for the Dial brand.• Managed 2 direct reports including day-to-day activities, performance reviews and technical development.• Collaboration on cross-functional teams to ensure that products met marketing expectations as well as stability, safety and efficacy requirements. • Developed and maintained mutually beneficial relationships with suppliers, academic researchers and outside inventors in order to bring unique products and materials to R&D.• Technical writing including patents, SOPs and test methods.• Lead the R&D recruiting program and worked closely with management to hire top talent. Drove interest in employment with Henkel by attending career fairs, visiting schools and presenting to students.

Scottsdale, Az

• Functioned as Sub-Investigator on multiple clinical studies under an IND.• Developed a PCR method to detect cold viruses in samples from study volunteers.• Close collaboration with leaders in cold and flu research to develop clinical studies to test an anti-viral hand treatment.• Led in-house clinical studies to test the antibacterial efficacy of liquid hand soaps and antiperspirant-deodorant products.• Technical writing and presentations of findings and data to diverse groups including upper management, marketing, legal and product development.

Phd, Biochemistry

Dissertation: Protein Components and Nucleases Involved in the Regulated Turnover of alpha-Globin mRNA.

Bs, Biochemistry