Katherine Barsnica

Experience

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  Celgene

  Jan 2001 - Jan 2004

  Supervisor

  • Oversaw production of human-derived medical device (AmbioDryTM). • Provided initial serological/medical history review of biologic material, and batch record review. • Participated in lab expansion and qualification of Class 100,000 modular clean rooms.• Prepared shipments of medical devices to end users and maintained accurate finished goods inventory.

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  Valera Pharmaceuticals (acquired by Indevus Pharmaceuticals)

  Nov 2004 - Mar 2009

  Production Supervisor

  • Oversaw production of drug implants (Supprelin LA®, Vantas®). • Created controlled documentation as per cGMPs (SOPs, WIs, CAPAs, investigations, protocols and reports) and performed batch record review.• Maintained supply & work in process inventory via Great Plains Business Solutions.

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  Indevus Pharmaceuticals (acquired by Endo Pharmaceuticals)

  Mar 2009 - Jun 2010

  Technical Services Project Manager

  • Managed technology transfer activities for US clinical and commercial products, with minimal impact to operations and in accordance to regulatory filing calendar, all of which resulted in lower cost of goods.• Preparation of CMC regulatory documents for post approval changes and annual reports.

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  Endo Pharmaceuticals

  Jun 2010 - Jun 2013

  Sr. Project Manager, R&D

  • Responsible for the management of drug implant and device development projects and phase I clinical trial activities. ­ - Managed the preparation of regulatory US submission (IND) and responses to deficiency letters.­ - Led design control activities such as failure mode effects analyses (FMEAs), design verification and validation.­ - Maintained device master file (DMF) and associated regulatory documents.­ - Generated SOPs to support the development of a new Clinical department infrastructure on site.­ - Maintained trial master file (TMF) and associated regulatory documents.­ - Participated in site initiation visit, monitoring visits and close out visits.­ - Managed all activities in the preparation, shipment, training, and return of clinical trial material. Show less

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  Beta Pharma

  Jan 2013 - Jan 2015

  Regulatory / Clinical Consultant

  • Oversaw preparation of submissions (IND, CTA, AR, amendments, etc.) to FDA and other Health Authorities in accordance with applicable regulations, related guidance documents, and established timelines. • Reviewed and approved documents (forms, modules, labeling, package inserts and clinical documents including: Investigator Brochures, Clinical Study Protocols, and Informed Consent documents) for submissions.• Supported compound specific CMC development activities for drug candidates from candidate nomination continuing through development up to first commercial manufacturing scale.• Development of Quality conscious corporate infrastructure. - Initiated development of Quality System for site compliance and audit readiness. - Reviewed batch documentation, protocols, reports, methods, data, CRFs, monitoring reports, etc. Show less

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  OZKAT solutions LLC

  Nov 2013 - now

  President

  Collaborator & Consultant for the Pharma-Med Device Industries.OZKAT assists companies in the development and execution of strategies to effectively meet urgent and long-term product development needs. Using diverse experience, OZKAT provides administrative and project management services related to product development (device and drug), operational issues, clinical trial supply management and regulatory submission preparation.

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  PAREXEL

  May 2015 - Aug 2016

  Program Manager / Senior Consultant

  • Managed outsourced regulatory affairs and operations project engagements (small <1M or large >1M).• Responsible for accurate financial management of project budget and timely client invoicing.• Served as the primary point of contact for overall program management activities and planning resource needs based on the submission schedule.• Prioritized own work load and the work load of the project team in order to achieve project objectives.• Reviewed the work of colleagues for content and quality to ensure the expectations of the client are met. Show less

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  Ophthotech

  Sept 2016 - Mar 2017

  Project Manager

  • Works cross-functionally and collaboratively with Clinical, Regulatory, CMC, QA, Commercial, R&D, Finance and Legal to support injectable Drug and class II Device Development projects.