Associate Director, Analytical Development

Astex Pharmaceuticals, Inc. (“Astex”) is committed to the fight against cancer. Astex is developing a proprietary pipeline of novel therapies for the treatment of solid tumors and hematological malignancies and has several products being developed in collaboration with leading pharmaceutical companies. Astex is a member of the Otsuka group of pharmaceutical companies. which also includes Taiho Pharmaceutical and Taiho Oncology. We are looking for an experienced and motivated professional interested in applying their unique skills to our shared mission. Our office is located in Pleasanton, California in the Rosewood Commons campus near the Dublin-Pleasanton BART station.

The Associate Director, Analytical Development will be responsible for leading analytical development projects within the CMC team, including collaborating with CMOs to ensure methods are developed and qualified to regulatory requirements, liaising internally with QA/Regulatory/CMC to set specifications, and to ensure drug lots are tested and released to meet project timelines and clinical needs. The position will focus on drug substance analytical development and also contribute in a team environment to solve CMC problems. They will also be responsible for writing drug product-sections related to analytical in the IND, IMPD, and NDA.

Responsibilities:

• Serve as analytical lead for drug substance/drug product for a drug development project, accountable for analytical deliverables according to project needs and stage of development
• Focus will be on drug substance analytical development
• Ensure phase-appropriate methods are developed and validated ahead of batch manufacture and testing through development of drug substance and drug product
• Ensure all required analytical testing of drug substances and drug products in clinical development is completed according to agreed timelines
• Perform technical review of batch release and stability data for drug substances, and drug products
• Review analytical documents data for raw materials and intermediates
• Collaborate in the preparation and review of analytical methods descriptions, method validation/transfer protocols, and reports
• Provide expert input and coordinate the development, qualification/validation, and/or transfer of technically sound analytical methods at global CMOs to meet project timelines
• May perform or plan experiments in an in-house laboratory for development and improvement of analytical methods, such as HPLC, LC-MS, KF, etc.
• In collaboration with the CMO, draft stability protocols for batches including registration stability batches
• Work with Specification Committee and QA to set product specification and assign shelf life. 
• Author CMC CTD sections such as batch analysis summary, justification of specifications, stability, analytical methods, and method validation
• Incorporate relevant regulations and guidelines (e.g., GMP and ICH) into the development of methods, validation/transfer protocols, and stability studies
• Manage reference standards associated with assigned program(s)
• Actively participate in resolution of technical issues during manufacturing, testing, and release of clinical trial material at contract sites
• 10% travel may be required to visit CMOs as needed. Analytical work is contracted externally.

Qualifications:

• PhD in chemistry or related discipline
• 8+ years’ relevant experience in a pharmaceutical analytical environment focusing on small molecules
• Strong background in organic chemistry is desired
• Hands-on experience with phase-appropriate analytical method development, validation, and transfer
• Good understanding of drug substance starting material development
• Proficient with analytical methods and instrumentation, particularly HPLC
• Familiarity with additional techniques such as LC-MS, Karl Fischer water determination, and GC preferred
• Prior experience drafting regulatory documents, IND and IMPD, and responding to agency requests
• Work and/or supervise in a laboratory, depending on position level and project needs
• Effective oral and email communication, including cross-cultural teams. Solid technical writing skills
• Experienced with pharmaceutical data review and good attention to detail
• Experience with preparation/review of analytical methods documentation such as procedures, validation protocols and reports
• Knowledge of pharmaceutical GMP requirements and QA systems 
• Must be motivated to take initiative, solve problems, and complete tasks in a timely manner
• Must be committed to teamwork within the CMC group and CMO teams