Associate Director, Biologics CMC Analytical Development
ASSOCIATE DIRECTOR, BIOLOGICS CMC ANALYTICAL DEVELOPMENT
This position will function as the analytical lead overseeing analytical development and QC related activities of monoclonal antibody at the contract manufacturing for Drug Substance and Drug product. The responsibilities include CMC regulatory filing.
Essential Duties and Responsibilities:
- Provide strategic and scientific guidance as the large molecule analytical development expert on biological assays, test method development, validation and establishment of specifications
- Oversee analytical activities at CMOs for drug substance and drug product manufacturing including the troubleshooting/investigation of the analytical testing issues
- Support Quality, Regulatory Affairs and 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 analytical method development, biochemical characterization
- In-depth experience and knowledge in large molecule analytics. Must have experience in other CMC functional areas: Cell Culture, API Purification, Drug Product
- Broad knowledge of the biopharmaceutical industry, including in-depth operating knowledge of the processes and functions involved in biologics drug development and comparability assessment
- Experience in recombinant protein 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.