Director - CDMO

Location
South San Francisco, CA, United States
Posted
Feb 17, 2021
Ref
760673172
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Graphite Bio is a clinical-stage biotechnology company focused on harnessing the power of targeted DNA integration. Integral Medicines uses next-generation CRISPR based technology platforms for developing curative gene correction-based stem cell therapies for serious and life-threatening genetic diseases with inadequate existing treatment options

Summary: In this role you will build, lead and manage a global network of clinical development and manufacturing activities for Graphite's Gene Therapy products

What You Will Do:

    • Develop strategies, priorities and goals for CDMO supply.
    • Establish a reliable network of clinical contract development and manufacturing organizations (CDMOs) for Phase I through commercial supplies.
    • Develop and negotiate technology transfer and manufacturing /supply contracts that reflect Graphite's process requirements.
    • Track, monitor and drive adherence to Graphite and CDMO contractual commitments, obligations, and processes. Ensure Graphite's expectations, goals and performance standards for cGMP compliance, product quality, production, delivery performance, Safety, Health and Environmental regulations and customer service are consistently met.
    • Establish practical business and risk management processes for CDMO operations in close collaboration with key partners
    • Provide leadership, guidance, and development of direct staff. Foster a productive work environment. Manage department budget and resource planning

 


What You Will Bring:

 

 

    • BS, MS or PhD in Chemistry, Chemical Engineering, Life Sciences or a related scientific/engineering discipline
    • 10 years of experience in the pharmaceutical industry, preferably with experience in Process/Technical Development and managing global contract manufacturing and 3rd party Relationships
    • Strong demonstrated 5+ years of people leadership and management experience with cross-functional teams.
    • Experience developing, negotiating and administering clinical and/or commercial contract manufacturing / supply agreements for cGMP production.
    • Demonstrated business acumen and operational leadership capability.

 


Fit with Graphite Bio's 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 Graphite Bios' Core Values

Excitement about the vision and mission of Graphite Bio

Flexibility

Integrity

Compensation/ Benefits:

Competitive salary with equity

Free on-site gym access

Free on-site meals and coffee bar

Health benefits

Graphite Bio 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.