Lead Financial Systems Analyst@Emergent BioSolutions
Verified
Thirty years of experience in technical and financial roles. Twenty of those years involve IBM Cognos TM1/Planning Analytics. Designing and implementing financial analysis tools. BS in Accounting
MS in IT with focuses in Software Development, Business Information Systems, and Decision Support Systems.More...
NICOLETTE Coffin
Senior Director, Product Development PM@Emergent BioSolutions
Verified
Emergent BioSolutions continues to make strides in the development and distribution of medical countermeasures for public health threats. As the Senior Director of Product Development PM, Nicolette Coffin plays an integral role in these advancements. Her leadership in product development, project management, and cross-functional team collaboration has contributed significantly to the company's mission. Currently, Nicolette's focus is on overseeing the development of innovative solutions and ensuring the delivery of high-quality products to the market. Her expertise in project management, coupled with her strong strategic planning skills, continues to drive the company's growth and success in the competitive biopharmaceutical industry.More...
Kelly Muechler
Compensation Leader
Verified
Kelly Muechler, as the Compensation Leader, is responsible for developing, implementing, and managing the company's compensation strategy. This includes setting competitive and equitable compensation levels, ensuring compliance with legal requirements, and aligning the compensation strategy with the company's overall business goals. Kelly's role is critical in attracting, retaining, and motivating employees, as well as in maintaining the company's financial sustainability. Her expertise in compensation analysis, job evaluation, and salary administration is pivotal in creating a fair and motivating work environment.More...
Michael Hale
Senior Director of Manufacturing@Confidential
Verified
Michael Hale is a seasoned industrial professional currently serving as the Senior Director of Manufacturing at a Confidential company. With a career spanning over two decades, he has demonstrated dynamic leadership and strategic planning skills across multiple roles in the manufacturing industry. Michael's expertise lies in process improvement, lean manufacturing, and supply chain management, which have consistently resulted in significant cost reductions and productivity improvements. His ability to drive operational efficiency, coupled with his strong team management skills, has contributed towards his reputation as a result-oriented leader in the manufacturing sector. Michael holds a Bachelor's degree in Industrial Engineering, reflecting his deep understanding of production processes and systems.More...
Michael Delitala is an accomplished Quality Management Systems Process Owner with extensive experience in the biotechnology industry. He possesses a strong track record in Inspection Readiness and Participation, Root Cause Analysis, Deviation Management, Corrective and Preventive Action (CAPA) Management, and Technical Writing. Michael is recognized for his detail-oriented approach, effective communication skills, and ability to collaborate cross-functionally. His professional competencies also include Deviation Trending and Training, showcasing his commitment to maintaining high-quality standards and ensuring compliance in complex environments.
In 2024, Michael founded Delitala Quality Consulting & Author Corporation, where he serves as Chief Executive Officer. He is also a published author of seven works, contributing to the knowledge base within the quality management domain. Prior to his current role, he held the position of Associate Director of Quality Systems & Compliance at Avidity Biosciences, Inc., where he was integral to advancing the company's mission to revolutionize RNA therapeutics, emphasizing the importance of tissue selectivity and precision in therapeutic development.
From 2021 to 2023, Michael served as the Global Head of Training & Quality Risk Management at Kite Pharma. In this role, he oversaw global programs for Personnel Qualification & Training, implementing a comprehensive quality management system. His leadership was crucial in the successful rollout of multiple phases of the Next Generation Quality Management System, ensuring that all regulatory requirements were met while enhancing the overall customer experience.
Earlier in his career, Michael was a Senior Manager of Quality & Compliance at Amgen, where he played a key role in developing an AI-driven tool for deviation trending that won the 2018 Quality Innovation Awards.More...
George Anello
Director of Quality Assurance & Regulatory Affairs@MedDevice Quality Experts
Verified
MedDevice Quality Experts continues to maintain its high standards in Quality Assurance and Regulatory Affairs. We have successfully implemented new quality assurance protocols, leading to a decrease in product defects and an increase in overall product quality. Our regulatory affairs team has effectively navigated recent changes in industry regulations, ensuring our full compliance. We are also improving our risk management strategies, focusing on proactive measures. Our commitment to continuous improvement and adherence to regulatory standards position us well for future growth and success. FDAQSR and ISO 13485 expert.More...