Director, Chemical Development

Location
South San Francisco, California
Posted
Feb 05, 2018
Discipline
Science/R&D
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

DIRECTOR, CHEMICAL DEVELOPMENT

The Director of Chemical Development will be responsible for the development and implementation of robust synthetic processes to support small molecule programs with the goal of delivering preclinical and clinical drug substance batches meeting program needs. The candidate will report to of the head of the process development and manufacturing 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 is the norm and exceptional communication and interpersonal skills are needed.  

Essential Duties & Responsibilities:

  • Manage Chemical Development group to deliver a robust chemical synthesis process for research and development programs
  • Responsible for phase appropriate synthesis route design, practical implementation of synthesis processes and controls for regulatory starting materials, intermediates and drug substances
  • Lead optimization activities in early stage and lead/support optimization activities in late stage
  • Lead fate and tolerance studies, genotoxic impurity evaluation and establish the framework of for the control strategy of the drug substance from early development with a long-term vision of the commercial process
  • Lead/Support technical transfer of starting material, intermediate or API processes between sites as needed
  • Work closely with cross functional teams to ensure seamless transitions between drug substance and drug product programs and vendors
  • Ability to coordinate with internal and external quality control, quality assurance, and regulatory personnel to resolve technical issues or deviations
  • Participate in an interactive, team oriented culture, interfacing primarily with the discovery functions and the CMC team
  • Critical review of proposals from CROs or CMOs; perform appropriate due diligence as needed to ensure CROs and CMOs can support the requirements of individual chemical development programs effectively
  • Implementation of risk based approach to development, QbD and DoE principles at appropriate development stages
  • Support PAR studies and pre-validation and validation activities for drug substance
  • Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings as needed
  • Build appropriate risk management strategies for chemical development and manufacturing
  • Up to 25% travel will be needed for scientific project management and monitoring of critical project activities

Qualifications:

  • PhD. in synthetic organic chemistry, minimum of 12 years of experience in the small molecule pharmaceutical industry 
  • Laboratory experience required
  • Hands-on experience with different stages of drug substance development
  • Chemical development experience with chiral molecules and chiral crystallizations preferred
  • Thorough understanding of the synthetic and analytical techniques necessary for proper polymorph screening, optimization, and patent protection
  • The ability to interact and effectively share synthetic route selection, design, and development knowledge with cross functional teams
  • 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 experience preferred
  • 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 race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.

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