Teaneck, New Jersey, United States
Outstanding communication abilities combined with detailed analytical and technical skills make me highly qualified to support the growth and success of an organization. Unique qualities and skills include: Dedicated leader | Innovative problem solver | Organized researcher and thinker | Quick and adaptive learner of new techniques | Exceptional ability to collaborate and communicate with a variety of people
Promoted to act as laboratory leader, responsible for delivering technical expertise and guidance across all activities related to quality control, to support the manufacturing and laboratory testing of cosmetic and OTC products. Oversaw the output of both in-house and third-party microbiological and analytical testing laboratories. Conducted laboratory out of specification investigations, provided feedback to relevant parties, and implemented appropriate corrective and preventive action plans as necessary. Performed root cause analysis for any laboratory-related non-conformances and recommended corrective actions to quality assurance. Lead and implemented continuous improvement projects as directed by upper management in alignment with cGMP requirements. Managed a team of laboratory personnel, handling employee recruitment, training, and retention while maintaining high laboratory performance and team satisfaction through coaching, counseling, and appraising staff. Select Achievements: -Rigorously documented staff training for all lab-related tasks, including test method qualifications for all analytical methods performed in-house. -Implemented a new laboratory out of specification management procedure to streamline the investigation process and escalate non-conformities to quality assurance for implementation of CAPA plans.
Ensured all in-house analytical testing was completed on time and complied with established protocols. Worked with internal global experts to standardize testing of raw materials and bulk products, ensuring methods and specifications were current and accurate. Reviewed and approved laboratory-related customer specifications. Updated laboratory documentation such as SOPs and SOIs to reflect current and best practices. Assisted quality, manufacturing, and R&D teams during product investigations. Prepared laboratory output trend reports by gathering, analyzing, and summarizing data. Ensured laboratory compliance with all relevant safety regulations. Responsible for developing and managing laboratory work schedules, prioritizing, and coordinating activities for seven direct reports. Select Achievement: -Developed a new raw material standard program with increased focus on pigment raw material color matching to reduce color related adjustments during production
Promoted to drive Avon’s R&D pipeline by independently planning and executing projects to address business needs. Provide guidance and measurement science support to internal R&D partners, including Toxicology and Regulatory Affairs as needed. Support global supply chain and manufacturing operations through autonomously managing critical quality control requests, providing guidance and making decisions on raw material quality. Manage equipment inventory including repairs, maintenance, and future investments, including interaction with vendor representatives to negotiate contract terms. Facilitate purchasing and track spending for the $150,000+ combined analytical and instrumentation budgets. Interviewed, trained, and mentored analytical staff in various group functions while managing one direct report. Select Achievements: -Assumed single-point responsibility for the finished ingredient specification program including outlining a definitive process for flammability and physical state testing. -Overhauled raw ingredient out of specification management across all global production sites, provided training of this process on the group level. -Worked collaboratively with cross-functional teams to harmonize raw ingredient specifications between sister companies within Natura & Co to create significant cost savings in LATAM. -Successfully re-negotiated instrument maintenance contracts for cost saving of over one thousand dollars.
Worked collaboratively across the R&D organization, providing expertise supporting products in all stages of development and those on the market. Determined and performed analytical testing to assist product development teams with new formulas and validation of product claims. Played a key role in establishing specifications for new raw materials. Created and updated methods and SOPs for global quality control analysis and instrumentation usage. Maintained all lab instrumentation. Select Achievements: -Developed analytical methods for the quantitation of critical ingredients in cosmetic formulations including updates to D4, D5, and D6 analysis for regulatory compliance. -Provided vital dermal delivery analysis and data for award-winning Protinol launch in collaborative work with the upstream skin care team.
Handled and maintained numerous pieces of laboratory equipment. Notable accomplishments include method transfer from HPLC to UPLC for Steviol Glycoside analysis and execution of statistical study to develop run acceptance conditions for HPLC analysis. Performed UPLC method optimization to achieve greater efficiency and sensitivity, reducing run time and increasing critical peak resolution. Classified numerous properties of polyol and dextrose syrups including pH, moisture, viscosity, and reducing sugars as part of an internal database expansion.
Promoted to be responsible for the development, validation, and optimization of bioanalytical methods: finding solutions to problems related to the application of methods, coordinating resources used, and supervising the relevant work of associate research scientists and laboratory technicians. Other responsibilities include writing and reviewing SOPs and participating in software testing.
Promoted to work with Principle Investigator to ensure that studies are performed in accordance with scientific and regulatory guidelines in a timely and cost effective manner. Completed PK, ADA, and NAb projects in sample analysis, method development, and method validation with minimal supervision. Lead analyst for multiple sample analysis and validation projects. Responsible for the review of Molecular Devices SpectraMax, MSD Sector S 600, and EnVison Plate Reader performance qualifications. Assisted with training of new employees.
Responsibilities included following procedures in Test Methods for method development,validation, and sample analysis, understanding proper procedures for handling and maintaining laboratory equipment including balances, pipettes, pH meters, and plate washing and reading equipment, and maintaining laboratory notebooks in addition to any other required documentation as per GLP standards.