STEPHANIE PETAWAY-HICKSON

Morris Plains, New Jersey 07950

973-***-****

ad4cm6@r.postjobfree.com

https://www.linkedin.com/in/stephaniepetawayhicksonmba/

SUMMARY

A dedicated and well-rounded senior technical operations professional specializing in the pharmaceutical industry, with comprehensive global and domestic expertise in product development, technical writing, regulatory compliance, reporting and documentation, and policy development. Manages the technical operations regarding the manufacture of a globally distributed biological products. Facilitates the creation of the documentation required for the establishment of novel processes for a new pilot laboratory. Develops a suite of impactful products, including an oral antibiotic powder. Proven success in fostering excellence across the board to support leading scientific enterprises.

Staff Coaching and Training Inventory Control Production Management

Data Analysis Vendor Relations Batch Records Drug Discovery

Change Management Procurement Services Formulation Development

EXPERIENCE

CAMBREX, Whippany, New Jersey Senior Technical Writer, Feb 2022 - Feb 2024

·Developed new, detailed manufacturing and packaging instructions based on complex and diverse documents provided by internal and external client technical resources. Managed and controlled manufacturing documents during multiple revisions, ensuring accuracy of original documents and integrated changes.

·Worked to edit, standardize, and field changes to material prepared by other writers.

·Performed investigations utilizing current SOPs and investigation tools.

·Collaborated with SMEs to capture best practices and accurate documentation.

·Prepared technical services sections for annual product reviews in collaboration with QA.

·Organized material and completed writing assignments according to set standards regarding order, clarity, conciseness, style, terminology, and SOPs. Maintained records and files of work and revisions.

·Recommended changes to process to enhance efficiencies and improve current processes.

·Gained familiarity with production processes and methods by building productive relationships with production, engineering, validation, and development personnel.

·Observed production, developmental, and experimental activities to understand detailed operating procedures and methods to create effective manufacturing documents. Coached and trained new hires.

·Assisted technical services SMEs in preparation of validation reports, data integrity, and event resolution.

JOULE (at BMS-Summit West - S12), Summit, New Jersey CAR-T Manufacturing Batch Record Reviewer, Lead,

Jul 2021 - Jan 2022

·Supervised and managed daily activities of direct and indirect reports within manufacturing operations batch record review group and ensured achievement of key goals on timely basis.

·Led and managed training of personnel. Developed, counseled, managed, and motivated staff.

·Promoted timely review of documentation of executed manufacture batch records.

·Compiled and coordinated batch record review metrics.

·Reported issues with and delays to batch record review and proposed solutions to resolve accordingly.

·Performed supplemental investigations and projects as required.

JOULE (at BMS-Summit West - S12), Summit, New Jersey Operations & Strategy - Technical Writer,Dec 2020 - Jul 2021

·Facilitated technical writing of reports for non-GLP nonclinical pharmacology and exploratory toxicology studies conducted within Celgene translational department, experimental toxicology / therapeutics and external collaborators.

·Participated in study and project team meetings and assisted teams in resolving issues related to document preparation.

·Worked and collaborated with NCD document specialist and regulatory operations department to initiate, author, review, and approve electronic documents.

·Attended product development team and department group meetings for info regarding upcoming needs for nonclinical writing.

·Implemented strategy for document preparation and NCD review to include time frames that meet or exceed company standards as well as document review processes.

·Facilitated document review meetings and discussions.

·Reviewed work of other writers (in-house and contract) for overall accuracy, quality, focus, and adherence to format and stylistic requirements. Managed other duties / responsibilities as assigned.

ESPHARMA (at RECORDATI RARE DISEASES), Lebanon, New Jersey Manager, Technical Operations, Manufacturing,

Dec 2019 - Jul 2020

·Provided day-to-day manufacturing oversight and supply chain manufacturing activities in support of RRD biopharmaceutical product manufactured for treatment of patients suffering from rare disease. Worked collaboratively with U.S.-based RRD cross-functional team as well as with U.S.- and foreign-based CMOs for manufacturing, testing, and packaging.

·Led and managed weekly meetings with cross-functional team and local and foreign CMOs for manufacturing to discuss timelines, inventory, supplies, CMC documentation, change control, and forecast.

·Provided technical oversight over local and foreign CMO activities and local packaging activities to ensure consistent adherence to quality contracts, RRD manufacturing standards, product specifications, and timelines.

·Worked with supply chain for procurement of raw materials as well as shipment of intermediates and final product.

·Partnered with U.S. and foreign RRD regulatory to ensure compliance with FDA, INVIMA, and ANVISA submissions.

·Supported activities to maintain RRD product marketability in U.S. and foreign markets upon CMO change.

·Developed and fostered existing relationships with colleagues and CMO representatives.

·Ensured effective communication with third-party manufacturing partners on relevant activities and provided technical oversight and RRD feedback in support of manufacturing activities, manufacturing investigations, and change controls.

·Promoted change control efforts to ensure continuous commercial product supply and regulatory compliance adherence.

NEWAGESYS, INC. (at NOVARTIS Cell Gene Therapy Development and Manufacturing), East Hanover, New Jersey Technical Writer Coordinator, Oct 2018 - Dec 2019

·Led creation and revision of GMP documentation, including production batch records, standard operating procedures, and related documentation. Acted as project leader. Prepared and maintained plan for preparation of all required documentation (including SOPs) to support overall project plans.

·Coordinated activities for documentation preparation with all stakeholders.

·Supported preparation of qualification master plans, risk and impact assessments, protocols, and summary reports and coordinated review and approvals of documents. Authored, revised, updated, and assisted with developing departmental standard operating procedures and qualification documents and programs.

·Supervised technical writers in assisting analytical and process science on authoring developmental protocols and reports.

·Ensured all activities proved in compliance with cGMP, health authority regulations, and Novartis policies.

ANI PHARMACEUTICALS, Baudette, Minnesota Principal Scientist, Feb 2017 - Sep 2018

·Drove and managed formulation and process development for filing submissions, including NDAs, ANDAs, CBE30, and PAS as well technology transfer activities.

·Led weekly meetings with cross-functional team to discuss test results, timelines, inventory, supplies, equipment, CMC documentation, change control, budget, patentability, and forecast.

·Participated in core team meeting (included marketing and regulatory affairs).

·Authored and executed documents to include protocols, reports, batch records, and technical assessments.

·Designed experiments and analyzed data. Coached operators on new products, processes, and equipment, including blenders, granulator, tablet press, and bottle filling and packaging. Engaged and communicated with cross-functional team.

·Assisted manufacturing and packaging with process and packaging related investigations.

·Developed oral powder antibiotic formulation, manufacturing process procedures, and packaging process.

·Created batch record and compatibility and hygroscopicity studies in various containers and closures.

·Procured and managed storage of API, excipients, and packaging materials.

·Ordered equipment accessories and parts.

·Worked with regulatory and QA to ensure appropriate studies to support PAS submission strategy.

·Co-created process verification protocol. Participated in CAPAs.

·Developed nasogastric administration study to support claim.

Led oral antibiotic product to earn FDA PAS approval for all three packaging configuration.

·Ameliorated ANDA antidepressant coated tablet formulation (three different strengths) and two different final blend formulations (presented prior scientist compression and dissolution issues).

·Demonstrated high moisture content of blend, leading to changes in formulation manufacturing procedure..

KELLY SERVICES (at J&J CONSUMER (dba McNeil Consumer), Fort Washington, Pennsylvania Formulation and Process Development Scientist, Aug 2016 - Feb 2017

·Assisted in coordination and product development activities for oral combination pharmaceutical solution.

·Maintained training proficiency on cGMPs, SOPs,, testing procedures, and data analysis as required.

·Reviewed regulatory documents and provided input as required for NDA and ANDA submissions.

·Led risk management planning as well as achievement of project’s milestones.

·Assisted in development and executed project tasks per established timelines.

·Analyzed data, provided recommendations based on sound scientific rationale, and summarized conclusions in technical reports.

·Troubleshot complex technical issues with substantial impact on product quality and business outcomes, including packaging select and impact on stability and raw materials and assessment / suggestion of stability studies.

ADVANCED CLINICAL (at FERRING PHARMACEUTICAL), Parsippany, New Jersey Senior Scientist (Full-time / Consulting),

Nov 2015 - Apr 2016

·Identified new technologies and innovations for peptide and protein oral drug delivery.

·Compiled CMC information and reported to formulation director and senior vice president.

CALIBRATION TECHNOLOGIES, Morristown, New Jersey Regulatory and Compliance Manager (Part-time / Consulting),

Jun 2014 - Nov 2015

·Worked closely with president on quality management system, GMP, SOPs, OSHA compliance, ISO 17025-accreditation assessment and preparation for external audits.

ADDITIONAL EXPERIENCE

BAYER HEALTHCARE CONSUMER CARE, Morristown, New Jersey, Staff Product Development Scientist, Formulation, Nov 2002 - Jan 2014. Managed in-house and CMO activities pertaining to product development of assigned OTC pharmaceutical products. Created required documentation and procedures in compliance with cGCP (for manufacturing of placebo and drug). Developed formulation and manufacturing process for drug products launched in U.S., EU, and Latin America. Led technical cross-functional teams to complete ANDA, NDA, European, and LATAM submissions. Developed formulations and manufacturing process for analgesic, cough and cold, gastro-intestinal, and nutritional products. Designed and executed an in-vitro / in-vivo correlation study

BAYER PHARMACEUTICALS, West Haven, Connecticut, Associate Research Scientist, Pre-Formulation and Formulation, Aug 2000 - Nov 2002. Created and developed formulations for oncology, diabetes, and obesity new chemical entities / drug molecules. Developed formulations for selected discovery compound animal studies. Acted as core project representative for assigned projects. Provided reports for CMC dossier for IND and NDA submissions. Conducted and reported physical-chemical characterization properties for drug compounds, including solubility, LOD, morphology, pKa, Log P, excipient compatibility, microbial growth, photosensitivity, and salt screening. Received various company awards of recognition.

ADECCO (at BAYER PHARMACEUTICAL), West Haven, Connecticut, Associate Research Scientist, Pre-Formulation and Formulation, Feb 1999 - Aug 2000. Developed formulations for selected discovery compounds’ animal studies. Designed non-clinical and clinical formulation(s). Conducted and evaluated physical-chemical properties and acted as department’s core project team representative for assigned projects. Provided reports for CMC dossier for IND and NDA submissions. Conducted and reported physical-chemical characterization properties, including solubility, LOD, morphology, pKa, Log Po/w, excipient compatibility, microbial growth, photosensitivity, and salt screening.

UNITED STATES SURGICAL CORPORATION (COVIDIEN), North Haven, Connecticut, Senior Chemical Technologist, Quality Control, Apr 1991 - Dec 1998. Assisted / supervised technicians and disseminated daily assignments. Reviewed GMP manufacturing processes batch records. Led review physical and chemical test results for release of raw material, intermediates, sterilized products, and final products. Conducted weekly meetings with cross-functional team and local and foreign CMOs for manufacturing to discuss timelines, inventory, supplies, CMC documentation, change control, and forecast. Trained technicians on use of analytical laboratory instruments / equipment, SOPs, ISO9000 regulations, safety issues. Troubleshoot and repaired analytical equipment.

SARGENT MANUFACTURING CO., New Haven, Connecticut, Plating Chemist, Plating Department, 1988 - 1991. Supervised and maintained the metal finishing coating and stripping processes, and maintained the waste water treatment systems in compliance with Department of Environmental Protection (DEP) and Environmental Protection Agency (EPA) regulations.

YALE NEW HAVEN HOSPITAL, New Haven, Connecticut, Certified Pharmacy Technician, (Details provided upon request).

EDUCATION

FAIRLEIGH DICKINSON UNIVERSITY, Teaneck, New Jersey, M.B.A.

ALBERTUS MAGNUS COLLEGE, New Haven, Connecticut, Masters of Business and Leadership

SOUTHERN CONNECTICUT STATE UNIVERSITY, New Haven, Connecticut, B.S., Chemistry

COMPUTER SKILLS

MS Office Suite, Skype, SharePoint, TrackWise, Documentum, Veeva Vault, and Python.

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