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Associate Director, Process Chemistry

Posted on Apr 5, 2021 by Astex Pharmaceuticals

Pleasanton, CA 94566
Research
Immediate Start
Annual Salary
Full-Time


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




Reference: 1152695249

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