Manager, CMC Operations

Location
94588, Pleasanton
Salary
Competitive, DOE
Posted
May 19, 2021
Required Education
Bachelors Degree
Position Type
Full time

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. This position will be based in our office located in Pleasanton, California in the Rosewood Commons campus near the Dublin-Pleasanton BART station.

The Manager, CMC Operations will be responsible for coordinating internal cross-functional integration of project deliverables/activities within CMC disciplines. This position will work closely with CMC project leadership and Quality teams to own operational activities within the department. As a key member of the CMC team, this individual will be responsible for managing all departmental finances including ownership of the budgeting process, management of purchase-to-pay activities, and tracking material cost of goods. This individual will also help manage the CMC supply chain, including supply forecasting and planning, global shipping, importation, and tax coordination. This individual will assist the CMC project leaders with project planning by assisting internal and external stakeholders in preparing and executing program strategy and project plans. This is an onsite position reporting to the Senior Vice President, Product Development.

Responsibilities:

  • Manage CMC material resource allocation and planning to support project deliverables including coordinating shipments, import/export activities, and tax coordination.
  • Assist with development and management integrated CMC timelines for CMC scientists, Contract Manufacturing partners (CMOs), and internal QA teams for clinical product development, analytical development, and release of clinical batches.
  • Coordinate and facilitate CMC Team meetings and CMO meetings (regularly scheduled and ad hoc) by providing meeting agendas, minutes, and tracking action items.
  • Develop and provide consistent project tracking and project reporting to CMC Senior Management and project teams.
  • Ownership of departmental budget development for CMC projects. Own and track purchase-to-pay activities to make sure project budget goals are met. Generate and track material cost of goods. 
  • Act as CMC leader for review of business documents including Master Service Agreements and Work Orders.
  • Act as a liaison between the CMC and Legal groups to facilitate the execution of these documents.

Qualifications:

  • Minimum education: Bachelor’s degree in a life sciences discipline or engineering. MBA is a plus.
  • Minimum 7 years’ pharmaceutical industry experience
  • CMO/CRO management experience is desirable
  • Exceptional communication and overview skills
  • Demonstrated ability to prioritize and plan realistic deadlines
  • Flexible, adaptable, and possess strong cooperative/team skills
  • English language proficiency: Fluent