Senior Scientist (Manager – Director), Process Chemistry - Pleasanton, CA | Biospace
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Senior Scientist (Manager – Director), Process Chemistry

Astex Pharmaceuticals, Inc.

Location:
Pleasanton, CA
Posted Date:
2/15/2017
Position Type:
Full time
Job Code:
17-10R
Salary:
Competitive: DOE
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Cancer, Chemical Engineering, Chemistry, CMC, Development, Director, Engineering, Manager, Manufacturing, Manufacturing/Production, Oncology, Organic Chemistry, Pharmaceutical, PhD, Process, Process Development, Project Management, Purification, Senior Scientist,

Job Description

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 Senior Scientist (Manager – Director), Process Chemistry will be primarily responsible for providing support and technical oversight on Astex sponsored research and development activities conducted at external Contract Manufacturing Organizations (CMOs). This role will lead technical efforts and generate innovative solutions to manufacturing problems and requires cGMP manufacturing experience combined with 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. Title will be commensurate with experience.

Responsibilities:

•   Design and develop manufacturing processes by overseeing 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
•   Interact with support and technical staff at CMOs to transfer and implement existing process manufacturing knowledge for development phase programs
•   Design and oversee Quality by Design (QbD) activities performed at external Contract Research Organizations (CROs)
•   Prepare Requests for Proposals (RFPs) to support vendor selection activities and 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%

Requirements

Qualifications:

•   BA/BS/MS/PhD, Organic Chemistry or Chemical Engineering
•   Pharma/biotech industry experience in pharmaceutical development and manufacturing preferably with small molecules (minimum 10 years with a BA/BS/MS; minimum 7 years with a PhD)
•   Expert proficiency with handling, synthesis, route development, purification, and characterization of complex organic molecules
•   Experience manufacturing highly potent APIs is highly desirable; working with nucleosides is a plus
•   Proven track record of working with CMO partners to deliver on project milestones
•   Working knowledge of cGMP and regulations applicable to international regulatory agencies is required; experience working in a cGMP manufacturing environment 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
•   Excellent oral and written communication skills

Astex Pharmaceuticals is an Equal Opportunity Employer