Analytical Lead for all the Company Projects

Consultation in all aspects of CMC.

- Managing and directing analytical activities including method development, transfer and validation as well as specifications, IPC's, cleaning verification, stability studies, release testing of incoming materials, intermediates, API's and reference standards.- Implementing cGMP compliant procedures and data management systems to archive and track analytical activities.- Authoring/reviewing SOP's, technical reports and sections of regulatory filings.- Actively communicating, consulting and collaborating with colleagues and clients to ensure optimal execution and record of analytical activities.

• Directing all analytical activities for pre-commercial projects • Hands-on in lab method development if needed• Developing new analytical techniques such as for example qNMR• Directing and managing analytical development for new chemical entities and new formulations• Coordinating development of analytical tests for starting materials, API, Drug Products and process intermediates • Overall responsibility for company cleaning verification policies and procedures• Coordinating acquisition of and requirements for analytical documentation/data/reports needed to support or be included in submissions to INDs and NDA applications, amendments, supplements and Annual Reports• Coordinate activities within the Company and external contractors as needed• Oversees and coordinates analytical development at Arena and with external contractors for new drug substances• Assuring high standards of analytical skill within the company

Acted as the interim Director of Analytical Development for a group of 13 staff members, managed an annual budget of $1M and successful implementation of several stability programs to predict the shelf life of various drug products. Acted as Analytical Expert within the company and led analytical outsourcing activities through selected CROs. ♣ Directed method development, validation and transfer for 1) Assay and identification of degradants/impurities drug substance and drug product; 2) Dissolution for release and stability; 3) Residual solvents; 4) Cleaning validations.♣ Led bioanalytical aspects of clinical studies and auditing; submitted several IND/NDA/ANDA filings.♣ Maintained frequent interactions with FDA, Health Canada and other regulatory agencies such as USP.