Britt Kostraba Email & Phone Number

Boston, Ma, Us

As a Project Engineer, I work with a cross-functional team to design and develop new combination products, product improvements, and production process improvements. More specifically, I have successfully completed the following:● Planned, executed, and supported milestone tasks for multiple pharmaceutical and medical device projects from concept to pre-commercial● Developed and managed the continual execution of the drug product stability programs per ICH guidelines● Planned and executed the implementation strategy of biocompatibility and drug compatibility testing ● Lead supporting efforts in pre-commercial drug product process development ● Authored NDA and Annual Report sections for multiple submission packages● Managed and lead backroom activities for audits

Managing the growth of the combination product pipeline as a subject matter expert in the development and assessment of both medical devices and pharmaceuticals through all project phases.● Assess potential next generation products through the development and continual improvement of the feasibility program for combination products.● Development of program protocols, reports, and milestones through commercial scale up.● Manage the development of analytical program for on-time delivery of commercially manufactured drug products in the US and EU.● Manage the implementation of the validation, verification, system testing, and method validation programs by authoring and implementing protocols, data analysis, and reports.● Effectively report key program statistics such as timeline, budget, and development to upper management.● Lead inter-departmental collaboration to identify potential IND and NDA submission gaps early in order to achieve human factors, clinical, and commercial success. ● Author 502(b) NDA and 510(k) sections for submission packages● Lead detailed discussions with audit inspectors as an SME and inspection room leader

Actively support the medical device development process through coordinating documentation and data analysis tactics with multiple scPharmaceuticals teams and outside vendors.● Supported implementation of Master Control documentation software while ensuring continuity within the quality systems. ● Collaborated with cross-functional teams to lead in the preparation of formative and summative human factors trials.● Collaborated with Quality Assurance team to implement product return and complaint investigation processes. Additionally collaborated in product complaint investigations, root cause analysis, and in developing corrective action plans.● Implemented logistics surrounding returned goods authorization process through interdisciplinary collaboration with multiple departments including quality, manufacturing, engineering, and supply chain.● Developed internal training course work and led group training to facilitate collaboration on documentation and the approval of documentation in Master Control. ● Supported data reporting and analysis using MatLab, Minitab, and Excel.