Join a company that’s making a difference in the fight against cancer. Astex Pharmaceuticals, www.astx.com, is dedicated to the discovery and development of novel small molecule therapeutics with a focus on oncology. Astex is a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan. We are looking for an experienced and motivated professional interested in applying their unique skills to our shared mission. This position will be based in our office located in Pleasanton, California near the Dublin-Pleasanton BART station in the Rosewood Commons campus: http://www.rosewoodcommons.com/transformation.html

The Associate Director, Process Chemistry will be primarily responsible for providing leadership and technical oversight on Astex sponsored research and development activities conducted at external Contract Manufacturing Organizations (CMOs). This role will lead technical efforts in late-stage product development and process validation. An ability to generate innovative solutions to manufacturing problems is needed together with cGMP manufacturing experience and a high level of proficiency with all technical principles of synthetic organic chemistry. Travel will be required on an as-needed basis to liaise with CMO staff and oversee production activities.

Responsibilities:

• Provide leadership in the discipline of process chemistry for API manufacturing projects within the Astex clinical pipeline
• Design and develop API manufacturing processes and manage activities conducted at CMOs
• Coordinate with analytical, quality, and regulatory staff to ensure activities being conducted at CMO partners are performed according to Astex’s expectations and appropriate standards
• Manage and guide technical staff at CMOs to transfer and implement and further develop existing process manufacturing knowledge for development phase programs
• Lead process chemistry efforts in the design, development and characterization of manufacturing processes such that they are suitable for process validation. Utilization of Quality by Design (QbD) principles, fate and purge studies in support of the preparation of regulatory documentation
• Prepare Requests for Proposals (RFPs) to support vendor selection activities
• Prepare Technology Transfer Packages (TTPs) to support technical transfer activities between CMOs
• Participate in vendor selection activities
• Assemble and write development reports
• Author and edit submissions to regulatory agencies
• Other duties as assigned
• Travel: Up to 30% (When feasible considering current restrictions)

Qualifications:

• BS/MS/PhD, Organic Chemistry or Chemical Engineering
• Pharma/biotech industry experience in pharmaceutical development and manufacturing of small molecule APIs (minimum 10 years with a BS/MS; minimum 7 years with a PhD)
• Expert proficiency with handling, synthesis, route development, purification, and characterization of complex organic molecules
• Proven track record of working in a project leadership role with CMO partners to deliver on project milestones
• Direct experience with developing and characterizing manufacturing processes suitable for process validation
• Working knowledge of cGMP and regulations applicable to international regulatory agencies is required; experience working in a cGMP manufacturing environment is highly desirable
• Experience manufacturing highly potent APIs is highly desirable
• Experience with statistical methods including Design of Experiments (DoE) required
• Strong problem-solving and troubleshooting abilities
• Ability to work independently and in a team environment
• Strong organizational skills
• Excellent oral, written and interpersonal communication skills