Experience

Ocular Therapeutix, Inc.

• United States
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Snr Director of QC and Analytical Development

  • Dec 2020 - Present

  Direct the development, planning, implementation, and maintenance of Quality methods, processes, and operations for new or existing products and/or technologies. Provide strategic and tactical leadership to the Quality organization ensuring the execution of responsibilities within the Quality Systems Direct the development, planning, implementation, and maintenance of Quality methods, processes, and operations for new or existing products and/or technologies. Provide strategic and tactical leadership to the Quality organization ensuring the execution of responsibilities within the Quality Systems



Alnylam Pharmaceuticals

• United States
• Biotechnology Research
• 700 & Above Employee

• Senior Director QC

  • Apr 2017 - Nov 2020

  Direct all QC activities of both external and internal QC groups. Support production, Manage expense and capital expenditures. Support NDA, EMA and PMDA filings and respond to information requests/deficiency queries form regulatory reviewers worldwide. Oversight of contract manufacturing and testing facilities in US, EU and Japan. Well versed in method development, method validation and method transfers. Management of QC staff and help with problem solving. Direct all QC activities of both external and internal QC groups. Support production, Manage expense and capital expenditures. Support NDA, EMA and PMDA filings and respond to information requests/deficiency queries form regulatory reviewers worldwide. Oversight of contract manufacturing and testing facilities in US, EU and Japan. Well versed in method development, method validation and method transfers. Management of QC staff and help with problem solving.



Floris Homan Consulting

• Clifton Park, New York, United States

• External Consultant

  • Jul 2016 - Apr 2017

  Retained consultant for Eagle Pharmaceuticals Inc. and Xgen Pharmaceutical Inc. Reviewed method validations and reports. Contributed to OOS investigations and CAPA. Provided interim leadership of QC, QA, and Regulatory Affairs functions during recruitment for permanent headcount in-house. Retained consultant for Eagle Pharmaceuticals Inc. and Xgen Pharmaceutical Inc. Reviewed method validations and reports. Contributed to OOS investigations and CAPA. Provided interim leadership of QC, QA, and Regulatory Affairs functions during recruitment for permanent headcount in-house.



Curia

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Director Global Analytical Development

  • Dec 2015 - Jul 2016

  Managed Analytical Teams in India and Albany New York to meet customers needs for Analytical Method Development and Release and Stability Testing of new APIs and Drug products from pre-clinical to Phase III and Commercial Products.

• Snr. Director, Analytical Development

  • May 2011 - Dec 2015

  Directed method development and validation activities as well as in-process, stabililty and release testing of early phase APIs and Drug Products.



Floris Homan Consulting

• St Louis, Missouri, United States

• External Consultant

  • May 2010 - May 2011

  Consultant/Principle Scientist for ABC Laboratories and Scientific Director for Dansol Pharma Group, LLC. Reviewed method validation protocols and reports, audited data and review RFPs. Participated in project selection and reviewed development reports and stability data of prototypes. Consultant/Principle Scientist for ABC Laboratories and Scientific Director for Dansol Pharma Group, LLC. Reviewed method validation protocols and reports, audited data and review RFPs. Participated in project selection and reviewed development reports and stability data of prototypes.



KV Pharmaceutical

• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Senior Director, Analytical Research and Development

  • Jul 1999 - Mar 2010

  Directed the activities in method development and validations in support of ANDA and NDA filings. Prepare capital, expense budgets for analytical department of up to 65 employees. Test and release clinical supplies and perform stability testing of prototype and submission batches. Analytical team member on external alliance projects, and material review board. Assist in due diligence audits and review of CMC section of ANDA and NDA submissions. Interact with regulatory agencies during inspections and responses to inquiries. Show less



Senetek PLC

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Vice President Research And Development

  • Aug 1997 - Jul 1999

  Directed the Research and Development activities pertaining to the current products for support of PLA, NDA and ANDA submissions (both in the USA and Europe). Led formulation development of new products. Assessed new business opportunities as they are presented to the company. Aided in the regulatory review of documents Directed the Research and Development activities pertaining to the current products for support of PLA, NDA and ANDA submissions (both in the USA and Europe). Led formulation development of new products. Assessed new business opportunities as they are presented to the company. Aided in the regulatory review of documents



Ferndale Laboratories, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director Quality Control Operations

  • Jul 1994 - Aug 1997

  Directed activities of Analytical Method Development (AMD), QC Chemistry, and QC Microbiology groups. Supervised the method development and validation activities prior to method transfer to QC. Set QC policies and participate in Corporate Strategic Planning. Prepared CMC sections of ANDAs for submission. Direct interaction with Field Investigators from FDA. Trained and mentored chemists and assisted in problem solving for both QC and Analytical Development. Directed activities of Analytical Method Development (AMD), QC Chemistry, and QC Microbiology groups. Supervised the method development and validation activities prior to method transfer to QC. Set QC policies and participate in Corporate Strategic Planning. Prepared CMC sections of ANDAs for submission. Direct interaction with Field Investigators from FDA. Trained and mentored chemists and assisted in problem solving for both QC and Analytical Development.



Telios Pharmaceuticals Inc

• Senior Manager, Analytical Development

  • Jan 1993 - Jul 1994

  Develop analytical methods to be transferred to QC. Troubleshoot QC assays and implementation of preliminary stability studies on new products. Assisted in formulation development. Authored analytical CMC sections of NDA and IND submissions. Develop analytical methods to be transferred to QC. Troubleshoot QC assays and implementation of preliminary stability studies on new products. Assisted in formulation development. Authored analytical CMC sections of NDA and IND submissions.



Telios Pharmaceuticals

• Senior Manager QC

  • 1992 - 1993

  Managed QC Chemistry and QC Micro. Coordinated the day to day activities including Raw Material, Intermediate and Finished Peptide Product testing, Stability Testing, and setting of specifications. Managed QC Chemistry and QC Micro. Coordinated the day to day activities including Raw Material, Intermediate and Finished Peptide Product testing, Stability Testing, and setting of specifications.



Centocor

• Biotechnology Research
• 400 - 500 Employee

• Group Leader, Quality Control

  • Oct 1991 - Aug 1992

  Supervisor of Physical Methods Testing. Areas of responsibility included Development and Validation of new methods, Raw Materials Testing, Finished Product, Intermediate, and In Process Testing. Additional responsibilities included training of technicians and supervising Stability Studies of Monoclonal Antibodies. Supervisor of Physical Methods Testing. Areas of responsibility included Development and Validation of new methods, Raw Materials Testing, Finished Product, Intermediate, and In Process Testing. Additional responsibilities included training of technicians and supervising Stability Studies of Monoclonal Antibodies.



Senetek PLC

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Manager, Organic Chemistry

  • Aug 1989 - Oct 1991

  Established a Processing facility for polymerization of HEMA(2-hydroxyethylmethacrylate) a polymer based chromatography sorbent, and initiated stability studies of Injectables. Established a Processing facility for polymerization of HEMA(2-hydroxyethylmethacrylate) a polymer based chromatography sorbent, and initiated stability studies of Injectables.



Survival Technology

• Analytical Chemist

  • 1984 - 1986

  Analytical Chemist Analytical Chemist