MAKENZIE PREMER
Marquette,KS
Summary
Recognized as a motivated, detail-oriented professional with a strong background in planning and implementing successful contract manufacturing relationships, investigations, third-party supply chain processes, interpreting and applying FDA regulations, and attaining quality aseptic processes. Twelve years of pharmaceutical industry practices and support for regulatory and customer audits. Develops project plans to support new product launches. Conscientious communicator who establishes and maintains effective working relationships across cross-functional teams. Extensive quality investigative skills used to identify creative solutions to unique problems. Focused on building a leadership career where past expertise can be applied, and new experiences are a welcome challenge.
Overview
13
13
years of professional experience
Work History
ACCOUNT MANAGER/INSIDE SALES
NITTO AVECIA PHARMA SERVICES
03.2024 - Current
- Manage and expand client relationships within the pharmaceutical and biotech industries to ensure satisfaction and retention.
- Serve as the primary point of contact for clients, providing both sales and technical support.
- Manage the initiation of Master Supply Agreements and Quality Technical Agreements between clients and Nitto Avecia.
- Identify and pursue new business opportunities to drive revenue growth.
- Conduct market intelligence activities, including the analysis of industry trends and competitor offerings.
- Develop and execute sales strategies to meet growth targets, and expand market share.
- Maintain accurate records of client interactions and sales activities in the CRM system.
- Collaborate with cross-functional teams (Business Development, R&D, QA, etc.) to ensure alignment of client needs and company capabilities.
- Prepare quotes and proposals for new business opportunities based on client requirements.
SR. EXTERNAL MANUFACTURING PROGRAM MANAGER
PFIZER, INC.
McPherson, KS
02.2018 - 03.2024
- Managed 6+ client accounts and 23+ sterile injectable products with unique product requirements.
- Oversaw the full product lifecycle, from development through commercialization, for liquid and lyophilized products.
- Served as an SME for batch records, investigations, change controls and customer communications.
- Prepared proposals and quotes for special projects and managed supply agreements.
- Facilitated product investigations to solve unique problems with complex variables, and identified actions to prevent unnecessary delays in product shipments.
- Provided clarity around technical documents, such as manufacturing, quality, supply contractual agreements, manufacturing and testing requirements, and process design.
- Actively involved as a member of the SAP planning team, I developed a strategy for a successful organization-wide implementation.
Quality Engineering Investigator
PFIZER, INC.
McPherson, Kansas
08.2014 - 02.2018
- Spearheaded writing investigation reports, orchestrating approval workflows, and coordinating with Area Management and Site Quality on deadlines and completion in TrackWise/QTS.
- Experience with closing 200+ investigations and CAPAs related to specific manufacturing areas, including but not limited to Carpujects, cartridges, ampuls, vials, aseptic manufacturing, terminal sterilization, label defects, and packaging.
- Utilized the 'Define, Measure, Analyze, Improve, and Control' (DMAIC) process to identify scope, perform root cause analysis, and identify effective CAPAs.
- Evaluated existing CAPAs and effectiveness checks to ensure they properly addressed the root cause to prevent further reoccurrence.
- Holistic review of batch records performed during the investigation process to identify the investigation scope and impact.
- Interfaced with regulatory compliance agencies and customer representatives during inspections and audits.
Pharmaceutical Attendant -SPA Equipment Prep
PFIZER, INC.
McPherson, Kansas
06.2013 - 08.2014
- Executed training for qualification necessary for equipment cleaning and sterilization.
- Reviewed and executed batch record guidelines and maintained SOP adherence in equipment setup.
Student Clerical Assistant
KANSAS STATE UNIVERSITY
Manhattan, KS
05.2012 - 05.2013
- Managed weekly updates for the Division of Communications and Marketing of the website for KSU News/Editorials; ensured the accuracy of new releases.
- Responsible for coordinating schedules to support appointments with students, customers, and clients on behalf of our organization; established a greeting procedure to create a welcoming environment.
Education
Bachelor of Science - Major: Marketing; Minor: Leadership Studies
Kansas State University
Manhattan, KS06-2013
Master Certificate - Project Management
Wichita State University
Wichita, KSSkills
- Project Management
- Quality Investigative Procedures
- Compliance Administration
- Customer Relations
- Problem-solving Principles Application
- Risk Mitigation
- Account Management
- Proposal/Quote Preparation and Delivery
- Market and industry knowledge
- Change Controls
- Customer Quality Audit Participation
- Budget preparation and maintenance
- Technical Writing
- 6 Sigma Yellow Belt
- Aseptic manufacturing process for injectable drugs
- SAP ERP
Additional Professional Development
- Maintains all required training for meeting GMP regulations.
- Annually completes more than eighty online/classroom courses related to all areas of aseptic pharmaceutical manufacturing.
- Method 1 Yellow Belt certification.
- Pfizer Human Performance (PHP) certified.
- Acting PC1 representative the ERP (SAP) implementation project for the McPherson site.
References
References available upon request.
Timeline
ACCOUNT MANAGER/INSIDE SALES
NITTO AVECIA PHARMA SERVICES
03.2024 - Current
SR. EXTERNAL MANUFACTURING PROGRAM MANAGER
PFIZER, INC.
02.2018 - 03.2024
Quality Engineering Investigator
PFIZER, INC.
08.2014 - 02.2018
Pharmaceutical Attendant -SPA Equipment Prep
PFIZER, INC.
06.2013 - 08.2014
Student Clerical Assistant
KANSAS STATE UNIVERSITY
05.2012 - 05.2013
Bachelor of Science - Major: Marketing; Minor: Leadership Studies
Kansas State University
Master Certificate - Project Management
Wichita State University
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