Head of Chemical Development
HEAD OF CHEMICAL DEVELOPMENT
The Head of Chemical Development will be a member of the Small Molecule Technical Operations leadership team. This position will partner with cross-functions on the CMC team to set the CMC strategies and lead the Chemical Development department to deliver the project needs.
Essential Duties and Responsibilities:
- Participate in cross functional discussions to develop and set CMC strategies
- Lead the Chemical Development function and supervise the process development and manufacture of starting materials, intermediates and drug substances for early stage to late-stage clinical phase small-molecule projects
- Oversee impurity evaluation and risk assessments, fate and purge studies and the establishment of phase appropriate impurity control strategies for drug substance
- Ensure compliance with company policies and quality standards, such as cGMP, SOPs, and FDA/EMA regulations
- Manage resource allocation, budgets and schedules for the Chemical Development function
- Oversee collaboration with external CMO/CDMO partners
- Lead the authoring and review of the related CMC sections of regulatory submissions (IND, IMPD, NDA and MAA)
- Partner with other departments (e.g. Supply Chain. QA, Regulatory) to optimize the internal workflow process such as change control, specification, etc.
- Subject matter expertise in process chemistry
- Demonstrated strong leadership in a multi-discipline collaboration environment
- Extensive experience overseeing outsourced CDMOs, including site qualification, technical transfer, and clinical manufacturing activities
- Good understanding of team dynamics, structure, roles and responsibilities
- Strong organizational skills and attention to detail
- Experience with authoring CMC sections for IND, NDA, MAA is highly desired
- Ph.D. in organic Chemistry, Chemical Engineering or a related scientific field with ideally over 12 years of pharmaceutical industry experience
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
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.