Edward DeSimone
Vice President Of Product Development at ANI Pharmaceuticals, Inc.- Claim this Profile
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Bio
Experience
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ANI Pharmaceuticals, Inc.
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United States
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Vice President Of Product Development
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Jul 2020 - Present
Serve as a member of the executive team that sets the company’s strategic direction for Product Development. Lead all aspects of product pipeline and pharmaceutical development, including API selection, sourcing formulation development and optimization, analytical methods development and validation, methods transfer, CMC, scale-up, packaging, stability studies, management and distribution of clinical supplies, and preparing CMC sections for regulatory filings. Where applicable, provide leadership for activities supporting commercial launch.Support in developing systems for the management and review of projects and provide/develop project tracking reports. In collaboration with the Product Development, Operations, Business Development, Quality and Regulatory Affairs teams.Ensure Product Development strategies, budget and timelines are consistent with development plans and goals. Oversee Product Development coordination of functions to ensure optimal development strategies and technical solutions.Select and manage Product Development CRO’s and vendors as the relate to API and formulation development and coordinate relevant activities. Work closely with Sales/Marketing, Operations and Regulatory Affairs to develop product pipeline strategies, proposals, FDA discussion documents, presentations, and filings. Show less
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Director - Analytical Services
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Feb 2018 - Jul 2020
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Eli Lilly and Company
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Operations Manager
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Mar 2015 - Nov 2017
Manage an organization of approximately 50 employees who are responsible for manufacturing a high volume biologic API. Participate in long range planning, business planning, and monthly financial planning with site and senior management. Drive an interdependent safety culture that believes that all injuries are preventable. Use cGMPs to ensure conformance to all regulatory commitments, SOPs, and compendial requirements. Manage the dispensing of a non-sterile API in an environmentally classified space that is consistent with ISO and Eudralex standards. Ensure shop floor conformance to Operational Standards for Supply Chain Excellence (OSSCE) standards. Show less
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Eli Lilly and Company
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Quality Control Manager
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Aug 2012 - 2015
Managed the laboratories responsible for the testing of process intermediates, final API release testing and stability testing for four commercial Biologic APIs and one pre-commercial biologic API.
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Quality Control Manager
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Nov 2009 - Jul 2012
Quality Control, Indianapolis API Responsible for the management of six laboratories supporting Biologic API Manufacturing operations in Indianapolis including: Raw Materials, Microbiology, Endotoxin, Environmental Monitoring, Water, and Fermentation product testing.Develop key metrics the organization and present conformance to these metrics to senior management.Manage headcount and workload, including personnel development, talent retention and organizational structure including building a capable and diverse workforce.Manage the organizational budget and participate in long range planning activities.Drive continuous improvement and cost reduction through various means including the utilization of six sigma tools and Black Belts.Serve as core member of the Insulin manufacturing flow team with responsibilities that include the development of site objectives, management of key metrics, manufacturing strategy decisions, and workload prioritization.Core member of the Insulin Technical Review Board (TRB) and Change Effectiveness Evaluation Board (CEEB); teams are responsible for reviewing deviations and change controls, driving thorough root cause analysis and deviation reduction initiatives.Laboratory Health, Safety, and Environmental (HSE) Team Leader. Drive injury reduction in all Indianapolis API laboratories and report key metrics to senior management.Manage an aggressive technical agenda throughout all of QC involving method modernization, new technology implementation, and testing simplification. This includes the commercialization of several new protein products. Show less
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Assoc Analytical Chemist Consultant and Chemist Consultant
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Jul 2007 - Nov 2009
External Manufacturing OrganizationManage a cross-functional group of scientists tasked with the outsourcing of two large molecule APIs to separate Contract Manufacturing Organizations (CMOs) overseas.Developed Technical Transfer Plans between the CMOs and Lilly to streamline the site certification process.Developed a consistent approach for method transfers including a template approach and standardized experimental designs for both Direct and Collaborative studies.Served as the Analytical Representative for Eli Lilly on the joint steering committees. Presented updates and metrics to senior management on the progress of the tech transfer.Led troubleshooting efforts and investigations into analytical issues, when necessary. Show less
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Analytical Chemist and Senior Analytical Chemist
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May 2003 - Jul 2007
Responsible for analytical method development and validation of analytical methods associated with several biologic API (proteins, peptides, and antibodies)Analytical steward for several biologic APIs across multiple sites and countries.Worked with cross-functional teams to develop a strategy for updating antiquated methods and validations to cGMP standards.Authored method validation protocols, coordinated the execution of these protocols with Contract Research Laboratories (CRLs), and authored summary documents.Managed the change control process for updating methods in cGMP systems across multiple sites, both API and Drug Product in multiple countries.Authored regulatory documents which were submitted to regulatory agencies around the world supporting method modernization.Participated in all regulatory inspections, including the EMA and FDA, as the laboratory Subject Matter Expert (SME).Performed Holistic review of API analytical testing for two large molecule APIs. Made batch release decisions based on these reviews and assemble Certificates of Testing (CoTs) for batch release.Managed the technical agenda for the API testing laboratory. Show less
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Kelly
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United States
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Staffing and Recruiting
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700 & Above Employee
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Associate Analytical Chemist
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Oct 2002 - May 2003
Responsible for release and stability testing of biologic APIs (proteins and peptides) in a cGMP laboratory. Aided in the development, validation and troubleshooting of analytical methods. Troubleshooting of analytical equipment utilized in the laboratory including HPLCs, GCs, and Atomic Absorption (AA). Responsible for release and stability testing of biologic APIs (proteins and peptides) in a cGMP laboratory. Aided in the development, validation and troubleshooting of analytical methods. Troubleshooting of analytical equipment utilized in the laboratory including HPLCs, GCs, and Atomic Absorption (AA).
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Process Development Scientist
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Feb 2001 - Oct 2002
Developed a laboratory scale extraction and purification process for a natural product oncology medication from raw materials to Final API. This process included: Solid/liquid extraction techniques Liquid/Liquid extraction/purification Solvent recovery/distillation Large scale chromatography Crystallization and rework Functioned as the key resource to commercialize this process from the laboratory to full scale production. Worked with Contract Manufacturing Organizations in 3 states and 2 countries to coordinate the manufacturing process at full scale. Provided on-site and remote troubleshooting for process related issues. Developed and validated the analytical methods utilized for process control. Devised separation methods using HPLC to analyze drug substance for potency and impurity content. Responsible for the set-up and site certification of analytical laboratories at 4 plant sites. Show less
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Lab Technician
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Mar 1998 - Feb 1999
Perform various organic extraction techniques on soil and water samples for analysis preparation Write and edit Quality Assurance Reports detailing material test results and conformance to specifications. Author and laboratory Standard Operating Procedures (S.O.P.'s) Perform various organic extraction techniques on soil and water samples for analysis preparation Write and edit Quality Assurance Reports detailing material test results and conformance to specifications. Author and laboratory Standard Operating Procedures (S.O.P.'s)
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Education
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Purdue University
Master of Science - MS, Biochemistry -
Creighton University
Bachelor of Science - BS, Chemistry