Director, Oral Product Development

Employer
Location
Waltham, MA
Salary
Competitive salary and benefits
Posted
Jun 02, 2018
Closes
Aug 02, 2018
Education
PHD
Career Fair Category
Career Fair

Director, Oral Product Development

 

There is nothing conditional about what we do.

Or who we are.

Or how we treat you.

We do what’s right.

We put science for patients first,

disrupting the model to go beyond

the concepts of conventional care.

We don’t treat a condition.

We treat people & partners.

We care to change the future.

Your Impact at TESARO:

The Director, Oral Product Development is responsible for building and leading a vertically integrated team of scientists/engineers responsible for the development and manufacture of oral drug products. The scope of the role encompasses the full breadth of the drug development lifecycle, ranging from the drug discovery/early development interface through technical transfer to commercial manufacturing operations and subsequent process validation. It extends further to the preparation of CMC content for regulatory (e.g. NDA/MAA) submissions and technical support for all in-market oral drug products following regulatory approval. 

Job Responsibilities:

  • Provide technical leadership, management and oversight for:
    • Development and scale up of robust drug product formulations and manufacturing processes based upon quality by design (QBD) concepts that address critical quality attributes and process parameters. Processes must ensure quality, afford satisfactory yields and provide for transferability to commercial manufacturing operations.
    • Manufacturing of non-GLP, GLP and GMP supplies of oral drug products necessary to facilitate TESARO’s non-clinical and clinical deliverables.
    • Registration and validation activities in support of the filing and ultimate launch of TESARO’s portfolio of oral drug products
    • Strategic partners used in the oral drug product development life cycle. Work closely with contract research, development and manufacturing organizations (CRDMO’s) to establish the appropriate operating oversight structure, development and manufacturing goals, program deliverables and budgets and ensures completion of agreed-to development activities.
  • Ensure coordination and oversight of analytical method development, qualification and validation activities associated with oral drug product characterization, lot release and stability testing.

Requirements:

  • PhD in pharmaceutics, pharmaceutical Science, pharmacy, chemistry, biotechnology (or related field) or BS/MS with equivalent education or experience is required.
  • Minimum of 10 years of experience in the pharmaceutical industry in small molecule drug product development with a minimum of 5 years in a CMC leadership role.
  • Expert knowledge of oral drug product formulation, manufacturing and process technologies and experience in advancing oral drug products through clinical development to successful regulatory approval/licensing

TESARO is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

FOR MORE INFORMATION, PLEASE CONTACT US AT careers2@tesarobio.com