Caprice Hightower
Summary
Project Manager develop projects plans, timelines, and budgets in collaboration with stakeholders and team members. Define project scope, goals, deliverables and monitor project progress while making necessary adjustments to ensure that the project stays on track and within budget. Prior to technical sales & project management, spent 15 years in the pharmaceutical industry performing (multi-step) organic synthesis, purification, and characterization of chemical compounds (HPLC, 1H NMR, LCMS). Performed method development, validation, technology transfer, and release testing of drug substance and drug product to meet strict GMP & ICH guidelines. Possess a comprehensive knowledge of drug development process. Focused Project Manager adept at planning, directing and maintaining continuous operations in various departments. Experienced in directing manufacturing employees and keeping efficient production in accordance with quality standards. Applying creative and analytical approach to operations for continuous process improvement. Skilled at identifying or anticipating problems and providing solutions. Excels through mentoring, training and empowering team to excel in performance. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
23
23
years of professional experience
1
1
Certification
Work History
Process Improvement Manager
Menarini Silicon Biosystems
05.2022 - Current
- Coordinate internal resources to manage timelines, risk, budgets, and overall performance of concurrent projects throughout the project's lifecycle
- Monitor project progress and make necessary adjustments to ensure that the project stays on track
- Identify and resolve issues that may impact project timeline or budget
- Proactively assess and address project needs, potential setbacks and consulting senior leaders as necessary
External Manufacturing Manager
Menarini Silicon Biosystems
05.2021 - 05.2022
- Assist in the development and implementation of optimal, cost-effective manufacturing methods in accordance with product specifications and quality standards, while maintaining relationships and communication with external manufacturers/vendors
- Maintain communication with external manufacturers and vendors to ensure adequate product supply
- Conduct weekly/bi-weekly meeting with external vendors and internal key stakeholders to ensure that adequate inventory levels are maintained, risks are identified/mitigated and projects are within scope on time and within budget
- Lead regular business review meetings with suppliers to provide an assessment of their performance, to ensure that all agreed KPIs are met (and or exceeded) and when applicable present potential new business opportunities
- Coordinate a team of Quality Assurance, Operations, R&D & Supply Chain colleagues in identifying & qualifying alternative suppliers to ensure that there are no disruptions in the supply of critical raw materials for manufacturing of final products and intermediates.
Scientific Project Manager
GLAXOSMITHKLINE
09.2020 - 05.2021
- Provided project management support to multiple Immuno-Oncology Companion Diagnostic teams to support the development and regulatory submission of diagnostic assays
- Support the EMU teams assisting with IVD partner due diligence, technical evaluation of biomarker technologies including on-site audits, partner meeting development, coordination of project deliverables including integrated timelines, reconciling project deliverables with accounting/invoicing and organization of documentation to support regulatory submissions and overall compliance expectations
- Function within CDx group will be responsible for defining the on-going support of activities with external partners, verifying the technical aspects of the developments, internal stakeholder alignment for governance meetings, provide regular communications and verifying deliverables have been met
- Accountable for the development and quality of integrated project plan (timelines, milestones, interdependencies, resources and identification/management of critical paths
- Responsible for ensuring consistent project management standards to enable effective portfolio management.
Regional Sales Manager
Gerresheimer Gx Solutions
01.2019 - 09.2019
- Identified sales opportunities & followed up with customers and established relationships to generate future sales and repeat business
- Served as the lead point of contact as the strategic lead for all sales and marketing activities for Central and Southeast USA
- Researched and identified sales opportunities through work with internal associates, business directories, industry publications and cold calling
- Responsible for the preparation of quotations and the development of confidentiality agreements (COAs) and Master Service Supply Agreements (MSAs)
- Attended conferences and tradeshows to promote Gerresheimer's Gx Syringes & Solutions portfolio
- Conducted seminars, sales presentations, product demonstration and training to customers
- Retained, expanded, and strengthened client relationships by ensuring high-quality customer service and issue resolution
- Reported sales forecast for SE & Central USA regions.
- Conducted product demonstrations and presentations to potential clients to capture more sales.
- Managed accounts to retain existing relationships and grow share of business.
Associate Project Manager
WuXi AppTec
03.2018 - 01.2019
- Lead and oversaw all project lifecycle efforts to develop and maintain project plans and timelines, communicated the project status reports to team members, project stakeholders, and management and escalated issues to insure prompt resolution
- Managed project contractual deliverables, including progress via metrics and adherence to contractual agreement time, quality/scope, and cost deliverables)
- Provided weekly updates to clients and internal stakeholders through meetings/conference calls & emails
- Utilized Microsoft Project to share timelines with internal & external clients
- Identified changes in scope, including new work orders and work order amendments, to be issued to the client
- Provided agendas, minutes and actions for all meetings and teleconferences
- Collaborated with Supply Chain, Manufacturing and Log-In to lead the shipping and receiving of the client's materials, testing samples or final product
- Provided client notification for quality events and drive completion of quality complaint investigations
- Knowledgeable of simple contract and quality agreement terms
- Utilized WuXi's financial systems to invoice and provided financial status updates to management
- Served as the main point of contact for all departments to ensure test reports dates were met.
- Maintained tactical control of project budgets and timelines to keep teams on task and achieve schedule targets.
- Maintained open communication by presenting regular updates on project status to customers.
Senior Technical Account Specialist
West Pharmaceutical Services
09.2015 - 09.2017
- Specialty technical products expert responsible for working with multi-national pharmaceutical companies by providing technical assistance relating to West's products, processes and services and assist in identifying and closing sales opportunities
- Applied product knowledge to provide packaging recommendation for parenteral drug products
- Responded to customer's technical issues by working with internal colleagues (Quality, Regulatory Supply Chain, R&D, Order Management, etc.) to provide resolution and customer satisfaction
- Delivered technical presentations during customer visits to assist account managers in closing the deals
- Utilized CRM to document all customer activities (calls, emails, sample requests, complaints, etc.)
- Collaborated with R&D and marketing teams and provided voice-of-customers feedback for product improvements and new product initiatives
- Attended tradeshows, conferences, & symposiums to provide product/service information.
- Interpreted clients' needs and introduced services to fit specific requirements.
- Maintained customer satisfaction with forward-thinking strategies focused on addressing customer needs and resolving concerns.
Manufacturing Technician IV
Siemens HealthCare Diagnostic INC.
06.2012 - 03.2014
- Chemical technician responsible for production work orders in the specialty reagent group with a focus on synthesis, purification, and characterization of large and small molecules in compliance with all GMP and GLP regulations
- Synthesized and characterized reagents & intermediates used in immunodiagnostic assays
- Documented all activities in the production worksheets as part of the device history record
- Drafted new documents as needed in support of process improvements and new product development
- Saved $300K by recommending process improvements that increased productivity, improved product quality and reduced waste
- Prevented testing delays by maintaining chemical supplies and ensuring lab equipment was calibrated and operational
- Developed and implemented corrective actions for unplanned (atypical) manufacturing events that would prevent their recurrence and eliminate waste of reworking or reproducing the requested materials
- Provided technical input and recommendations for reducing costs and improving quality of the product.
- Performed in-depth analysis of manufacturing processes, identifying areas for improvement and cost savings.
- Reported on findings and made proactive and targeted recommendation to senior leaders.
Associate Investigator
Dupont Stine HaskelL Research Center
12.2011 - 06.2012
- Conducted multi-step organic reactions for the synthesis, purification and characterization of novel compounds
- Prepared milligram to gram quantities of complex organic molecules for biological evaluation using parallel synthesis.
Scientist
AstraZeneca Pharmaceuticals
03.2008 - 12.2010
- Evaluated stability of drug substances and drug product from Discovery to Phase I clinical studies using HPLC and/or UPLC (Empower software), Mass Spectrometry, 1H NMR, Karl Fischer, and dissolution apparatus
- Performed method development, validation, technology transfer, and release testing of drug substance and drug product to meet strict regulatory guidelines
- Reported and interpreted the generated quantitative analytical data
- Carried out forced degradation and stability studies and identified impurities/degradation products by utilizing experience in synthetic organic chemistry
- Prepared CMC sections for regulatory submissions and Phase I Clinical Trials
- Conducted solubility and stability studies to assist formulators in evaluating the physiochemical properties of excipients and active pharmaceutical ingredient
- Utilized Microsoft Excel to generate analytical data.
Senior Associate Chemist
AstraZeneca Pharmaceuticals
01.2001 - 03.2008
- Developed synthetic routes for novel compounds and intermediates for treatments of anxiety, Parkinson's, Alzheimer and schizophrenia
- Identified opportunities to improve synthetic routes and to maximize productivity through parallel synthesis, automated and microwave technologies when applicable
- Utilized characterization (NMR, LC-MS & FT-IR) and purification techniques to ensure the quality and integrity of the candidate drugs
- Utilized chemical databases (SciFinder & ISIS/Base) to perform literature searches.
Education
Master of Science - Chemistry
Lehigh University
Bethlehem, PABachelor of Arts - Chemistry
Temple University
Philadelphia, PASkills
- Project Planning
- Meeting Facilitation
- Vendor Sourcing
- Customer Relations
- Cross-Functional Collaboration
- Technical Presentations
- Equipment Management
- Lab Equipment Calibration
- Continuous Improvement
- Task Prioritization
Certification
- Bi-Organic Principles of Pharmaceutical Science, Lehigh University, Bethlehem, PA
- Regulatory Affairs, Lehigh University, Bethlehem, PA
- Aseptic Fill/Finish of Parenteral Products For Sterile Drug Delivery, The University of Tennessee Health Science Center, Memphis, Tennessee
Timeline
Process Improvement Manager
Menarini Silicon Biosystems
05.2022 - Current
External Manufacturing Manager
Menarini Silicon Biosystems
05.2021 - 05.2022
Scientific Project Manager
GLAXOSMITHKLINE
09.2020 - 05.2021
Regional Sales Manager
Gerresheimer Gx Solutions
01.2019 - 09.2019
Associate Project Manager
WuXi AppTec
03.2018 - 01.2019
Senior Technical Account Specialist
West Pharmaceutical Services
09.2015 - 09.2017
Manufacturing Technician IV
Siemens HealthCare Diagnostic INC.
06.2012 - 03.2014
Associate Investigator
Dupont Stine HaskelL Research Center
12.2011 - 06.2012
Scientist
AstraZeneca Pharmaceuticals
03.2008 - 12.2010
Senior Associate Chemist
AstraZeneca Pharmaceuticals
01.2001 - 03.2008
Master of Science - Chemistry
Lehigh University
Bachelor of Arts - Chemistry
Temple University
- Bi-Organic Principles of Pharmaceutical Science, Lehigh University, Bethlehem, PA
- Regulatory Affairs, Lehigh University, Bethlehem, PA
- Aseptic Fill/Finish of Parenteral Products For Sterile Drug Delivery, The University of Tennessee Health Science Center, Memphis, Tennessee
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