Carole Kasloff

Richmond, VA 610-***-**** ac9ytp@r.postjobfree.com

Profile

Experienced Analytical Chemist specializing in pharmaceutical analysis of in-process samples, stability samples, and finished products. Successful background in R&D, Quality Control, Quality Assurance, and Regulatory Compliance with expertise in ICH, 21CFR, USP, EU and JP regulations. Excellent knowledge of FDA, EU and other global regulatory requirements, as well as the latest industry trends. Effective in increasing efficiencies to meet organizational objectives and delivering value in an organization as a key team member. Exceptional interpersonal and communication skills with superior problem-solving abilities. Other strengths include:

© Writing SOPs, Protocols, Methods and Reports © Shimadzu, Waters, and Agilent HPLCs © Agilent GCs, Waters UPLCs

© Informal and Formal Stability Samples © Regulatory Compliance © HPLC,GC and UPLC Methods

© Distek and VanKel Dissolution Baths © Vendor Material Comparison © Process Improvement

© Analytical Method Development and Validation © Equipment Calibration © cGMP and cGLP Compliance

Strong analytical expertise in HPLC, UPLC, FTIR/ATR, UV-Vis spectroscopy, GC, AA, Karl Fischer, TGA, DSC, pH, TOC, viscosity and dissolution testing. Familiar with LCMS. Emphasis on being a catalyst for change, driven to improve processes and operations while delivering breakthrough results throughout product development, testing, and manufacturing. Strong foundation of ethics, high degree of integrity, superior work ethic, and commitment to excellence combined with unrivalled service level support to maximize opportunities through driven, focused advancements in technology, laboratory procedures, training, and industry compliance.

Professional Experience

Pfizer/ExecuPharm 11/2018 - Present

n Scientist, Analytical Development

Working on a project involving nutraceutical products.

Running assay and degradants for products using normal phase, UPLC methods.

Contribute to the identification of unknown peaks in finished product and raw material samples.

Involved in optimizing UPLC methods for different formulations of the same product.

Participate in informal stability studies for the raw material as well as different formulations of finished product.

Running a compatibility study for raw material and excipients.

Analyze data obtained from assay development and routine analysis and document experiments and conclusions in an electronic notebook.

Ascertain that testing and studies are properly carried out and reported to efficiently support product development projects.

Perform analysis using traditional and state-of-the-art analytical techniques.

Develop and/or evaluate new test methodologies for analytical applications.

Noven Pharmaceuticals, Inc. 12/2016 - 10/2018

n Scientist/Analytical Chemist

Performed assays and related substances on transdermal patches to support the formulation feasibility and development of the products. Included work with controlled substances.

Assisted with developing and validating analytical methods.

Wrote standard test procedures and SOPs.

Facilitated HPLC testing, made detailed observations, analyzed data and interpreted results.

Calibrated analytical instrumentation at scheduled intervals.

Selected for and completed training for a Lead Investigator role within the organization.

Completed and maintained the lab notebook including writing deviations and laboratory incidents. Worked with Trackwise and LIMS.

Ensured compliance with all applicable regulations and policies. Ensured that work performed in area of responsibility was conducted in a safe and compliant manner.

Maintained familiarity with current scientific literature and trends.

Implemented Good Manufacturing Practices in the laboratory.

Carole Kasloff Page Two

Professional Experience

Genus Lifesciences, Inc. Allentown, PA 02/2010 - 11/2016

n Chemist III

Worked with controlled substances (Schedule II, III and IV), conducted analytical testing on tablets, capsules, and liquids for assay, related substances, active, and preservative for Stability and R&D and QC samples. Areas of accountability included testing of in-process and finished products, equipment utilization, regulatory compliance, investigations, monthly inspections, KPIs, validations, audits, inventory management and ordering, documentation, SOPs, and safety initiatives.

Operational Accountabilities

Performed raw material testing according to the current USP.

Sent out raw materials and finished product for outside testing

Audited raw data results and laboratory documentation.

Performed OOS investigations as described in the SOPs to establish integrity of data.

Participated in reviewing data and releasing finished product, stability samples and raw materials.

Member of the Safety Committee.

Reviewed date and participated in writing lab deviations.

Leadership Role

In charge of the Raw Material Department including testing of current and new raw materials, maintaining inventory for testing, and deciding what testing could be done in-house and what needed to be sent out.

Accountable for ensuring the HPLC and GC column inventory remained current.

Trained new analysts that were hired in the laboratory.

Wrote and revised SOPs, methods and specifications. Assisted in the process of methods development.

In charge of the Stability Department for five months and served as the ongoing backup for the Stability Coordinator when not available or on vacation.

Served as the backup for the supervisor when not available or on vacation.

Ortho-McNeil Pharmaceuticals, Inc./US Tech Solutions Raritan, NJ 09/2009 - 02/2010

n Associate Scientist (Contract), QC Group/Raw Materials

Performed testing on purified water, water for injection, raw materials and packaging components according to the current USP and EP.

Performed instrument qualification, calibration and maintenance.

Wrote laboratory investigations, deviations, methods, and SOPs.

Bracco Research USA, Inc./Pharmaceutical Clinical Associates, LLC Princeton, NJ 03/2009 - 09/2009

n Analytical Chemist (Contract), Pharmaceutics Group

Performed informal stability testing on lyophilized products and raw materials including LCMS.

Developed and validated a Karl Fischer method for raw material.

Conducted a column equivalency study for an HPLC method.

Performed a raw material vendor comparison to evaluate vendors for suitability for selection.

Tested customer complaint samples. Ensured adherence to GMP standards in the laboratory.

Updated SOPs and methods. Assisted in the development and validation of analytical methods.

McNeil Consumer Healthcare/Kelly Management Services Fort Washington, PA 10/2007 - 03/2009

n Senior Analyst, New Product Development Group

Worked in the R&D department on method and stability of new products in development phases including work with controlled substances.

Performed analysis and optimization of HPLC methods for active and impurities in liquid, lotion and stick samples.

Conducted pre-validation, as well as informal and formal stability studies on liquid, lotion and stick samples.

Performed analysis of new products in support of the Formulations Department.

Completed method transfers to the J&J, Research & Development Technical Center in Mumbai, India.

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Professional Experience

Ortho-McNeil Pharmaceuticals Inc./Kelly Scientific Titusville, NJ 10/2006 - 10/2007

n Analytical Chemist, Method Development Group

Provided support to the Method Development Group including responsibilities for method development, method validation, and writing methods and validation protocols.

Involved in troubleshooting and optimizing analytical methods.

McNeil Consumer Healthcare/Tunnell Consulting Fort Washington, PA 08/2002 - 09/2006

n Analytical Chemist

Conducted pre-stability studies, post-stability studies, and validation of the manufacturing area.

Independently supported stability studies on solid dosage forms and suspensions.

Served in a lead analytical role in the testing of in-process batches for the evaluation and validation of a new manufacturing area. Responsibilities included evaluating trends in the overall data of individual batches indicating possible manufacturing problems.

Participated in studies evaluating the possible interference from filters involved in drug recovery for dissolution testing.

Involved in validation of both the chromatographic methodology and extraction procedures for cleaning validation swab samples.

TEVA Pharmaceuticals Sellersville, PA 10/2000 - 08/2002

n Analytical Chemist

Performed analytical testing for the release of Teva Products, solid dosage forms, blends, and raw materials including controlled substances.

Provided analytical support to the Stability and Reference Standard departments.

Involved in the development of HPLC methods for the drug substance purity and analysis of the finished product.

Provided management with GMP documented analytical methods, validation protocols, stability reports, standard operating procedures, and certificates of analysis.

Fort Dodge Animal Health Princeton, NJ 04/1996 - 10/2000

n Analytical Chemist

Supported the clinical trials for the experimental ear tags by the sequential evaluation of clinical samples.

Developed the optimum sample extraction procedure and gas chromatographic assay for the determination of drug potency in cattle ear tags.

Extensively involved in the development, optimization and validation of HPLC and GC methods for several experimental formulations of different types of medicinal animal treatments such as de-worming pastes, pour-on, and injectable formulations.

Served in leadership role as the Laboratory Safety Coordinator for one year.

Education

Bachelor of Arts Degree in Chemistry - Graduated Magna Cum Laude

Temple University, Philadelphia, PA

Associate of Applied Science Degree in Medical Technology - Graduated with High Honors

Community College of Philadelphia, Philadelphia, PA

Computer Skills

Proficient in Microsoft Word and Excel, LIMS, Documentum, TrackWise, Empower, Open Lab and ChemStation

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