Associate Director, Chemical Development

Location
San Francisco, CA
Posted
May 30, 2019
Ref
511
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Associate Director, Chemical Development

Position Summary:

The Associate Director in Chemical Development will be responsible for managing contract manufacturing organizations (CMOs) for Drug Substance, providing technical guidance and project management for CMC activities. The successful candidate will be both a strong hands-on executor as well as strategic thinker and program manager.

This individual will be involved in the development and implementation of robust synthetic processes to support small molecule programs with the goal of delivering preclinical, clinical, and commercial drug substance batches meeting program needs. The candidate will report to the head of Chemical Development in Technical Operations.

GBT places a high value on cooperative team dynamics and a positive, "can-do" work ethic. The ideal candidate thrives in a hands-on, fast-paced environment where a strong sense of urgency and accountability is the norm and exceptional communication and interpersonal skills are needed.

Essential Duties and Responsibilities:
  • Manage the relationship between GBT and drug substance CMOs. Primary contact with CMO sites supporting tech transfers, clinical production and commercial production
  • Assist project lead to provide project management support and drive key activities to ensure successful execution
  • Collaborate with the drug substance leads to implement technology transfer and technical project plans for drug substance at CMOs
  • Oversee manufacturing at CMOs and provide technical support for investigations, deviations and OOS activities
  • May perform process R&D work when necessary
  • Support/lead identification and selection of CMOs to meet project needs
  • Support/lead late stage development activities such as risk assessments, and implementation of QbD principles
  • Support generation of CMC portions of regulatory dossiers and support IND, NDA, MAA and ROW health authority submissions
  • Perform project specific assessments and manage issues. Communicate appropriate product/technical risks, and constraints to Technical Operations management to enable sound business decisions
  • Provide insight on current regulations and guidance documents relevant to product development projects
  • Represent technical operations as a functional area representative in cross-functional project teams and CMO visits
  • Up to 25% of travel required

Qualifications:

  • BS/MS/PhD. in synthetic organic chemistry, minimum of 10 years of experience in the small molecule pharmaceutical industry
  • Laboratory experience required
  • Hands-on experience with different stages of drug substance development
  • Thorough understanding of the synthetic and analytical techniques necessary for proper polymorph screening, optimization, and patent protection
  • Thorough understanding of cGMPs, ISO, and ICH guidelines, and industry best practices
  • Experienced in Design of Experiments (DOE) and Quality by Design (QbD) principles
  • Commercial manufacturing or clinical manufacturing experience preferred
  • Experienced overseeing manufacturing at CMO sights required
  • Experienced in working with CMOs and CROs


Fit with GBT culture:
  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity


NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.