Director, CMC Manufacturing

Location
San Francisco, CA, United States
Posted
Apr 24, 2021
Ref
1088
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
DIRECTOR, CMC MANUFACTURING

Position Summary:

We are looking for exceptional individuals who share our passion for great science and an authentic commitment to develop and deliver life-changing treatments for people living with grievous blood-based disorders, starting with Sickle Cell Disease

This position will function as technical lead for downstream development and commercialization of biologic drug substance and drug product. Responsibilities will mainly focus on the development and execution of a BLA enabling GMP process characterization and process validation of a monoclonal antibody. The candidate will develop strategies and manage study execution and data generation for applicable global regulatory submissions. Deliverable expectations to include:

  • Partner with internal resources and external CMOs to drive process characterization and validation for a monoclonal antibody program
  • Plan, Design and execute major BLA enabling projects through sound DOE, early risk assessments and thorough itemization of applicable deliverables. Have full awareness of the potential consequences (defects and failure modes) of design parameters to established robust and reproducible processes
  • Lead technical process characterization and validation of a monoclonal antibody including risk assessments, process characterizations, variability assessments and statistical evaluation of multiple complex parameters
  • Company steward for obtaining the highest product quality including leading technical discussions and influencing stakeholder acceptance of critical process and quality-based decisions
  • Responsible and accountable for monitoring process performance/process history/ technical assessments and ownership of change controls and process deviations both internally and at CMO sites
  • Lead author for applicable regulatory sections in BLA submission


Essential Duties and Responsibilities:

  • Demonstrates in-depth knowledge of current Good Manufacturing Practices (GMPs)
  • Proficient in Stage 1, Stage 2, Stage 3 biologics validation including; PHA, CQA, CPP, KPI, DOE OFAT, PC, PV, PPQ, and continuous process verification
  • Excellence in breadth and depth across engineering disciplines and is recognized as a subject matter expert for bio process development, characterization, and validation
  • Strong biologics process characterization and validation, preferably with Monoclonal antibodies; Process Specific SME
  • Significant experience and contribution to generation of relevant regulatory sections of BLA and MAA filings, data capture and management, process monitoring and trending, including control charting and statistical process control, and supporting regulatory and site inspections
  • Extensive experience with Upstream and Downstream operations from thaw through DS. DP experience a plus. In-depth understanding of cell culture scale-up, engineering principles, and associated equipment - i.e. cell growth rates, nutrient consumption, gas transfers and velocities, titers and production rates
  • General knowledge of the workstreams in the development of monoclonal antibodies; upstream and downstream processing preferred. Formulation, drug substance and drug product development, molecule characterization, analytical development, and stability testing
  • Strong individual contributor. Must be able to work in a fast paced, multi-project and changing environment with ability to manage multiple competing responsibilities with a high degree of independence and self-motivation
  • Outstanding written and verbal communication skills
  • Strong organization and time management skills
  • Team Player. Ability to thrive in flat organizational structure with strong cross functional communications and contributions. The team output is greater than the sum of the parts. This Lean team depends on everyone working together for the common goals
  • Partner with Cross functional teammates from Tech Ops, Analytical, Quality Assurance, Regulatory, and Clinical Operations


Qualifications:

  • B.S./M.S./PhD. in Pharmaceutical Sciences, Chemical Engineering, Bioengineering, or related field with extensive experience in biotech or pharmaceuticals industry
    • 10+ years of relevant experience in the pharmaceutical industry and a BS or BA
    • 8+ years of relevant experience and a MS
    • 7+ years of relevant experience and a PhD in a relevant scientific discipline
  • Relevant industry experience in development of monoclonal antibodies or biologics platform modalities (5-8 years). Position level will be commensurate with education level and previous industrial experience
  • Biologics Process Engineering, MSAT, Technical Services SME
  • Demonstrates excellent verbal, technical writing, and interpersonal communication skills
  • Has proven analytical and conceptual skills
  • Demonstrates ability to effectively manage multiple projects/priorities


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 age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.

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