Customer Service Manufacturing

CLARK VanKOEVERING

860-***-**** ac7kwq@r.postjobfree.com

Glastonbury, CT www.linkedin.com/in/clarkvankoevering

MANUFACTURING PROJECT MANAGER TECHNICAL SUPPORT PROFESSIONAL

Proactive scientist with a proven record in providing project management support (planning, scheduling, coordination and technical support) to deliver manufacturing projects within budget and on time. Track record includes taking unproven drug product formulations and turning them into reality. Effective at using scientific approaches to solve complex technical support issues. Adept at building excellent rapport with internal colleagues, third-party contractors and suppliers from diverse business and scientific disciplines. Achievements are based on integrity, trust, commitment to succeed and deliver projects on time. Areas of expertise include:

Project Leadership (Phase I – IV Manufacture)

Technical Guidance

Formulation Development

Microsoft Excel, Power Point, Project, Word, SharePoint

cGMP Documentation, SOPs

Equipment and Process Qualification

Quality Investigations and Report Writing

Good Understanding of DMIAC principles

EXPERIENCE

Pfizer Inc. Global Research and Development / Drug Product Supply 2003 - Present

Principal Scientist, Manufacturing Projects Lead, Ann Arbor MI and Groton CT

Coordinate activities to manufacture clinical batches internally and at third-party contractors that include securing availability of materials and equipment, reviewing formulation data sheets and preparing batch documentation to ensure timely delivery of clinical supplies (immediate release tablets, modified release tablets, microspheres, capsules and liquid dosage forms) that meet all quality release requirements.

Project Management and Coordination:

Provided excellent customer service through real time project status updates and timely communications sharing batch performance metrics to cross functional team members within Supply Chain Lead, Science and Technology, Quality Assurance, and Analytical Control groups.

Improved project management tools (visual metric dashboard) for early stage clinical manufacturing projects to help display key milestones to other partner team members.

Effectively interacted with third party contractors to meet timelines which involved overseeing the operation and providing technical support at the vendor site.

Excellent record for delivering finished drug product on time.

Technology:

Provided operation oversight and troubleshooting capability for a wide range of solid dosage form technologies to ensure target product attributes are met.

Investigated manufacturing deviations with unforeseen manufacturing issues and provided trusted manufacturing insight and leadership needed during the investigation that resulted in timely resolution of quality deviations and assisted in root cause analysis or CAPAs for manufacturing operations.

Actively participated in the process development of several complex projects to ensure process robustness for new hot melt extruder and recommended modification for manual capsule filling equipment to adjust the capsule fill weight to a dose weight less than the capsule volume.

Clark VanKoevering Page Two ac7kwq@r.postjobfree.com

Technology (cont’d):

Actively participated in several Limited Duration Teams that included start-up of an Aqueous / Solvent Coating Pan to replace outdated equipment.

Collaborated with technical experts to optimize the compressing operation of bi-layer tablet formulations to limit intermingling of the active and placebo blue polymer blends on the machine. This enabled projects to complete on time and prevent need for 100% visual inspection of finished drug product batches.

Leadership:

Led best practices training series of several manufacturing unit operations to mentor staff at different career levels.

Implemented a controlled substance material handling program for both clinical manufacturing and inventory management operation teams. Worked with other subject matter experts within Pfizer to continually improve process flow for handling controlled substances at the Groton site.

Assisted in commercial readiness of a several tablet products planned for FDA approval to provide quality improvement initiatives and new technology implementation.

Received Special Recognition Awards for coordinating several complex internal clinical manufacturing campaigns and clinical supply manufacturing performed at a company commercial manufacturing site as well as at third party sites.

Led an equipment selection team to identify requirements for ordering new equipment.

ADDITIONAL RELEVANT EXPERIENCE

Manufacturing Professional III, IV and V

Technical Support and Engineering, Pharmacia and Upjohn, Inc.

Development Pharmacist I and II,

Pharmaceutical Manufacturing and Technical Support, The Upjohn Company

Research Assistant

College of Pharmacy, University of Illinois, Chicago, IL.

EDUCATION

Bachelor of Science in Pharmacy with a specialty in Industrial Pharmacy

University of Illinois, Chicago, IL

Bachelor of Science in Biology, Calvin College, Grand Rapids, MI

PUBLICATIONS AND PRESENTATIONS

RE Gordon and CL VanKoevering, "Utilization of Differential Scanning Calorimetry in Compatibility Screening of Ibuprofen with Stearate Lubricants," International Journal of Pharmaceutics, 21, 99-105.

CL VanKoevering and TW Rosanske, "A Preliminary Film Coating Study Using Production Scale Equipment: An Investigation of Different Application Rates", poster presentation at the Mid-West AAPS Regional Meeting, Chicago, IL.

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