Stephanie Rietwyk, Phd Email & Phone Number

Melbourne, Vic, Au

Melbourne, Victoria, Australia

- Manage the Quality Management System (QMS) and ensure company compliance with ISO13485:2016- Review production and manufacturing practices and documentation - Conduct Management Review Meetings- Manage change control process, customer complaints, supplier complaints, Non-Conforming Reports (NCRs), Corrective Actions and Preventive Actions (CAPA)- Conduct internal audits and assist with TGA and BSI audit- Input into new product development and transition into production- Manage and approve validation (IQ, OQ, PQ and PV) processes - Conduct training activities and manage training records- Manage product release process, packed product and label reconciliation- Ensure identification and traceability for all incoming goods and finished product

- Work independently and in a global matrix on various life cycle management and new product development projects - Perform high throughput screening of protein formulations, preliminary excipient screening and accelerated stability testing according to industry and regulatory requirements and standards- Provide scientific and experimental support to deviations in routine manufacturing and PTCs- Instrument performance qualification, preparation of protocols, reports and SOPs

Melbourne, Australia

- Work independently and collaboratively within a diverse team to develop new technologies and methods to address pharmaceutical industry issues and business opportunities- Understanding of industry driven projects and research-industry partnership- Data interrogation, design of experiment and problem solving- Formulation development, stress performance and accelerated stability testing- Solid-state characterisation of novel API - In depth data analysis and technical data oral presentation- Dual reporting (academia and industry)

Tel Aviv Area, Israel

- In-depth understanding of production and physicochemical characterisation of lipid nanoparticles - Developed an industrial-friendly protocol for production of drug-loaded lipid-collagen nanoparticles for treatment of inflammatory diseases- Investigated structure and characteristics of monoclonal antibody α-hTERT and assessed suitability as a universal marker for cancer cells - Data interrogation and design of experiment- Reported experimental outcomes to managers and collaborators at the Beilinson hospital - Peer-reviewed article drafting, submission and review- Technical data oral presentation at conferences- Managed daily laboratory tasks

• Customer service• Phone inquiries• Responsible for overseeing reservations and payments, enrolling new members, issuing and returning items, shelving books

- Determined structure formation during lipid digestion using synchrotron SAXS coupled with in vitro physicochemical characterisation tools to provide new approaches and insights for the rational design of formulations containing poorly water-soluble drugs- Data interrogation and design of experiment- Peer-reviewed article and beamtime proposal drafting, submission and review- Technical data oral presentation at conferences- Reported experimental outcomes to supervisors and collaborators- Honours student supervision - Demonstrated leadership by teaching undergraduate students in a class and laboratory setting- Exhibited time management and attention to detail in the critical assessment of exam papers- Managed daily laboratory tasks

- Tutored classes of 30 undergraduate students in a class and laboratory setting for Formulation Science and Product Development units- Critical assessment of exam papers for undergraduate Pharmacy and Pharmaceutical Science students

Melbourne, Australia

- Investigated lyoprotectants for lyophilisation of protein and conducted stability tests- Prepared drug-loaded liposomes, determined encapsulation efficiency by size exclusion chromatography and UV spectrophotometry

Melbourne, Australia

- Formulated lactose blends for dosing via an inhaler device under GMP guidelines- Determined bulk and tapped density, flow characteristics, fill weights and plug formation

Phd

Activities and Societies: Vice-President of Parkville Postgraduate Association (2013), Treasurer of Parkville Postgraduate Association.

Honours Degree In Bachelor Of Pharmaceutical Science, Pharmaceutics

Thesis topic: Phase behaviour and biological stability of liquid crystalline drug delivery nanomaterials

Bachelor Of Pharmaceutical Science, Formulation Science

Vce