David Breitenbecher
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David Breitenbecher Email & Phone Number

Pharmaceutical Operations, Manufacturing, & Supply Chain Executive
Location: Cincinnati, Ohio, United States 12 work roles 2 schools
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Role
Pharmaceutical Operations, Manufacturing, & Supply Chain Executive
Location
Cincinnati, Ohio, United States

Who is David Breitenbecher? Overview

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David Breitenbecher is listed as Pharmaceutical Operations, Manufacturing, & Supply Chain Executive based in Cincinnati, Ohio, United States. AeroLeads shows a matched LinkedIn profile for David Breitenbecher.

David Breitenbecher previously worked as Senior Vice President Operations at Lyra Therapeutics and Vice President of Manufacturing at Lyra Therapeutics. David Breitenbecher studied at The Ohio State University.

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About David Breitenbecher

David Breitenbecher is a Pharmaceutical Operations, Manufacturing, & Supply Chain Executive. Colleagues describe them as "I've had the privilege of working with David during our time at Lyra Therapeutics. David brings a remarkable blend of operational leadership, strategic vision, and a proven ability to navigate complex challenges with ease. Working at all levels of the organization, he maintains a collaborative and authentic leadership style that inspires trust and drives results. What truly sets David apart is his ability to stay calm under pressure and guide cross-functional teams to success. He consistently mentor’s others, fostering a culture of quality, continuous improvement, and best practices. With high integrity and a focus on achieving organizational goals while minimizing costs, David is an asset to any team." and "It has been my pleasure and honor to have worked with David at Boehringer-Ingelheim Roxane Inc. and at Alkermes. While with Boehringer David worked for me as a Unit Leader (Supervisor) in the Solids Manufacturing area and was an excellent employee and colleague. David's ability to grasp highly technical process, work within a team, develop those he supervises and develop cross functional/department relationships helped greatly in the efficient start up of a new solids manufacturing area while maintaining current commercial production to meet customer needs. The first thing I did when I arrived at Alkermes was call David and see if he would be interested in joining this organization. Since his joining Alkermes he has used his technical and team building skills to help improve processes and his ability to work well cross functionally to build strong relationships across the organization. I can think of no individual that I would give a higher recommendation to than David Breitenbecher, he is one of the best, if not the best, individuals I have ever worked with."

12 roles

David Breitenbecher work experience

A career timeline built from the work history available for this profile.

Senior Vice President Operations

Boston

• Prepared 5-year commercial capital strategy and presented to Board of Directors/Investors. Obtained approval to execute strategy contingent on positive top line results of phase 3 clinical results.• Successfully recruited, hired, and onboarded 30+ employees in anticipation of starting validation and commercialization of product.• Prepared 5-year commercial capital strategy and presented to Board of Directors/Investors. Obtained approval to execute strategy contingent on positive top line results of phase 3 clinical results.• Successfully recruited, hired, and onboarded 30+ employees in anticipation of starting validation and commercialization of product.

Jan 2024 - May 2024

Vice President Of Manufacturing

• Joined company during failing Tech Transfer to CDMO, lead effort to internalize manufacturing on an accelerated timeline. Successfully produced clinical batches allowing for the resumption of phase 3 clinical trial.• Consistently received positive feedback on Board of Director level interactions. Attended Board meetings where I presented data, reported statuses, and explained strategy/plans.• Developed hiring plan to grow from clinical operation to commercial operation.• Managed supply chain activities including vendor selection, evaluation, and clinical trial material supply.• Worked collaboratively with the research and development, engineering, and clinical teams to meet the current needs of clinical programs.• Responsible for team of manufacturing engineers, technicians, and project managers

Mar 2022 - Dec 2023

Senior Director Of Manufacturing

• Lead a department of ~250 manufacturing and engineering professionals. Responsible for sterile bulk and sterile fill finish manufacturing for Alkermes parental extended-release drug products. Other responsibilities included synthesis and purification of proprietary polymers, clinical biologics manufacturing operations, start-up of OSD clinical area, and production of clinical trial material.• Department comprised 13 teams operating twelve commercial manufacturing lines producing products responsible for 70% of the company revenue (> $750 million/year). Member of the Site Leadership, OpEx Implementation and Steering, CMC, and New Technology teams.

Jan 2017 - Mar 2022

Director Of Manufacturing

• Responsible for ~200-person sterile bulk and sterile fill finish for Alkermes extended-release drug products. Other responsibilities included Medisorb Bioresorbable polymers and large and small molecule clinical manufacturing operation groups. Accountable for the start-up of Aristada sterile bulk and syringe filling lines. Staffed and planned all areas of responsibility.• Maintained department budget and headcount. Department head responsible for production throughput and quality compliance.

Jan 2012 - Dec 2016

Associate Director Manufacturing

• Responsible for 60+ person sterile bulk, Medisorb Bioresorbable polymer, and small molecule clinical manufacturing. • Accountable for the start-up of scaled up polymer manufacturing unit and new bulk formulation line. Lead multiple investigations in product performance variation and equipment failure/reliability improvements.

Jun 2009 - Dec 2012

Manager, Manufacturing Bulk Formulations

• Managed operation of two manufacturing lines producing Risperdal Consta.• Accomplished completion of commissioning. • Earned Six Sigma Black Belt by finding root cause of filter dryer screen failures. Changes made as a result of investigation reduced screen failure rate from 20% to no failed screens.

Jan 2007 - Jun 2009

Process Engineer

• Installed low volume filter housings which resulted in a 200 g/batch yield increase.• Maintained and analyzed Bulk Line 2 process and QC data.

Jan 2006 - 2007

Production Manager

• Responsible for 8 supervisors and 100 employees in 4 functional areas. • Instituted individual production metrics tracking productivity of Azo-shifts and individual flush operators. • Achieved a general linear improvement in productivity. In September of 2005, 3 of 4 functional areas achieved record levels of productivity

Jan 2003 - Jan 2006

Process Engineer

• Achieved record production during my leadership as interim Azo-Production Manager. • Installed and supported data collection systems in Azo-Pigment Filtering and Drying Areas.• Designed and performed experiments leading to process and product improvements.

Jun 2002 - Jan 2003

Process Engineer

• Wrote process descriptions for unit operations of biopharmaceutical processes, including microfilters, ultrafilters, and bioreactors. Authored process descriptions for RO generators, clean steam generators, and CIP skids.

Jun 2001 - Jun 2002

Production Engineer

• Communicated with product development, production technology, and production to identify new process requirements. Wrote functional specifications for new equipment.

Apr 2001 - Jun 2001

Unit Lead

• Directly supervised production technicians, operators, and mechanics. Wrote and revised SOPs to reflect cGMP.• Analyzed production data to determine root cause of process deviations.• Lead continuous improvement team that implemented process improvements that ensured quality and increased efficiency.

Aug 1998 - Mar 2001
2 education records

David Breitenbecher education

Education record

Bs Che
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What is David Breitenbecher's role at their current company?

David Breitenbecher is listed as Pharmaceutical Operations, Manufacturing, & Supply Chain Executive.

Where is David Breitenbecher based?

David Breitenbecher is based in Cincinnati, Ohio, United States.

What companies has David Breitenbecher worked for?

David Breitenbecher has worked for Lyra Therapeutics, Alkermes, Cdr Pigments & Dispersions, Jacobs Engineering Group Of Ohio Inc, and Roxane Laboratories Inc.

How can I contact David Breitenbecher?

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What schools did David Breitenbecher attend?

David Breitenbecher studied at The Ohio State University.

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