Director, Biologics CMC Developement and Manufacturing
DIRECTOR, BIOLOGICS CMC DEVELOPMENT AND MANUFACTURING
This position will function as the technical lead overseeing upstream/downstream of monoclonal antibody drug substance process development and drug product manufacturing. The responsibilities include establishing CMC strategy, CMO management for development batches, scale up, validation batches and CMC regulatory filing.
Essential Duties and Responsibilities:
- Technical leadership for process development, analytical development, formulation development scale up, validation and manufacturing of biologic drug
- CMO management for drug substance and drug product development and manufacture
- Support Quality, Regulatory Affairs
- Author relevant CMC section in regulatory filings and address agency questions
- A degree Biochemistry, Chemistry, Chemical engineering or related discipline. PhD with minimum 10 years of experience, MS with 12 years, BS with 15 years
- Must have hands-on experience in process development, biochemical characterization and manufacturing support for biologics
- Experience in recombinant protein drug comparability assessments and submissions
- Must have excellent problem-solving skills and verbal and written communication skills
- Requires working knowledge of BLA submissions, Quality and regulatory requirements
- Self-directed and proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues
- Comfortable executing on multiple projects independently
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 race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.