Anthony K. Adams

Rodeo, CA ***** 510-***-**** acqqx6@r.postjobfree.com

www.linkedin.com/in/anthonykadams

Summary

Manufacturing Engineer with experience in process control and improvement and design control in In-

Vitro Diagnostics manufacturing. Expertise in Lean/Six Sigma principles, analytical chemistry, product

development and operating requirements in an FDA- regulated environment. Recognized as strong

liaison and communicator committed to team success.

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Lean Six Sigma Design Control

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Statistical Process Control GMP Documentation

• •

Validation FMEA

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Formulations/Mixing Risk Management

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QSR, ISO 13485

Professional Experience

Bio-Rad Laboratories, Hercules, CA

Manufacturing Engineer 2003 – 2014

Supported manufacturing and validation activities in the form of process management, failure

investigation and correction and transfer of new products from R&D to Production. Also conducted

raw material qualifications using knowledge of chemistry and product requirements to set acceptance

criteria, prepare protocols, generate and review data and prepare summary reports.

• Increased capability of EIA plate production 3 fold. Led team through DMAIC process to define

the problems, gather data to determine baseline conditions, map and analyze our processes to

identify Critical Process Parameters and sources of variation and implement changes in

production, in-line testing and adjustment to improve consistency. Also implemented changes in

final release testing to enable monitoring to maintain improvements.

• Served as Operations representative on Quality Audits of key suppliers for EIA kits.

• Brought the mixing aspect of HPLC buffer production in compliance with ISO and FDA as

engineering lead on Global Mixing Validation project. Organized products into families to limit

the scope of work, wrote and executed engineering protocols to establish mixing parameters and

wrote and supervised validation studies to prove compliance with specifications. Subsequent

audits produced no findings.

• Streamlined data entry for hundreds of new part numbers to create Chinese language labeled

kits, enabling timely production of kits under tight time to meet new regulations and avoid back

order issues.

• Established standard qualification procedures for over a dozen unique chemicals requiring

frequent re-qualification, eliminating that cause of back order.

• Eliminated waste in Biogenic Amines production process. Extended inventory life of scarce raw

materials by a factor of 5, while improving consistency of product performance.

• Completed over 10 design control projects for development and upgrades to instrumentation,

software and chemistries. Wrote Manufacturing Plans, Purchasing Specifications and Design

Output Reports as well as production and testing SOPs.

• Recognized as a valuable team member with the ability to facilitate effective communication.

Senior Scientist, Product Support Group 2001-2003

• Established trust with key subject matter experts in a small company purchased by Bio-Rad,

obtaining the knowledge necessary to write procedures for manufacturing and testing EIA test

kits and facilitating the transfer of manufacturing operations from their small facility to

Hercules.

• Identified critical flaw in HPLC packing equipment. Implemented transfer of packing process to

subsidiary with modern equipment and proven record of quality.

Other Relevant Experience

• Built library of chromatographic and spectral data and developed algorithm for their use in an

automated drug profiling system.

• Led team to develop a serum protein profiling assay based on capillary electrophoresis and

obtain 510k approval.

Education & Certifications

Bachelor of Science in Chemistry, ACS Certification, Rhodes College Memphis, TN

PhD candidate in Analytical Chemistry, ABT, Oregon State University

Lean/ Six Sigma Green Belt, Air Academy, Colorado Springs, CO

Technologies& Techniques

HPLC UV\Vis Spectroscopy Capillary Electrophoresis

GC Matlab DOE

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