Gary Held Email & Phone Number

Milwaukee, Wi, Us

Milwaukee, Wi, Us

Waltham, Ma, Us

Leading the analytical testing and development group in the quality control lab on a variety of DNA and RNA products to meet ISO13485. Subject matter expert in testing of phosphoramidites used in the manufacture of oligonucleotide therapeutics. Manage the testing workloads and facilitating validation and qualification of test methods and materials. Use lean tools to drive improvements in cycle time reduction and error proofing. Perform internal audits of other functional areas using a process model approach and assigning CAPA’s. As a Practical Process Improvement (PPI) Process Manager, train and coach teams through improvement projects determined to be critical to operational excellence. Lead World Class Enterprise team actives and training in the company including 5S, KANBAN, Kaizen, Value Stream Mapping, error proofing, Gemba walks, Tier accountability. Track site savings and improvement metrics to be reported at the division level.

Commercial Real Estate Investment Companies60,000+sq ft of commercial / retail space, multifamily apartments under ownership.

West Bend, Wisconsin, Us

$200 million Credit Union serving Washington County and Southeastern Wisconsin. Responsibilities include overseeing operations, developing strategies, identify synergies, assessing and mitigating risk and maintaining complete financial soundness of a growing Credit Union.

Responsible for the supervision of a ten member 24-hour/day analytical staff to support a growing pharmaceutical (API) manufacturer. This team conducts testing in accordance to cGMP’s to meet customer deadlines and quality standards. Set up and implemented the ability to test controlled substances (DEA Schedule I-V). Responsible for writing, reviewing and auditing SOP’s related to product testing or quality systems, as well as reviewed test results and laboratory documentation. Completed out of specification reports (OOS) and initiated corrective and preventative actions (CAPA). Provided data and explanation for FDA and DEA inspections. Worked with customers to facilitate analytical technical transfers and managed both contract and generic analytical projects to ensure compliance to cGMP’s. Provided data and reviewed regulatory information for filling DMF’s. Used Microsoft Project to keep on project timelines and uphold the company’s commitment to deliver high quality products on time. Member of the management team to review potential customers and prepare product quotations.

Schwarz Pharma Inc. is a manufacture of final drug products that must comply with FDA and cGMP requirements. My responsibilities included testing strength and release rate of manufactured drugs prior to release.

Mba, Management

Bs, Chemistry