Associate Director, Formulation Development and Combo Device

Location
San Francisco, CA, United States
Posted
Apr 24, 2021
Ref
1087
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
ASSOCIATE DIRECTOR, FORMULATION DEVELOPMENT AND COMBO DEVICE

Position Summary:

The AD owns the CMC development of a monoclonal antibody platform for a 1st in class subcutaneous injectable drug product for the treatment of Sickle Cell Disease (SCD). The position will collaborate with internal cross functional teams, consultants, and external contract manufacturing organizations. Responsibilities include development and execution of formulation DOE studies and IND enabling and activities at contract manufacturing organizations (CMOs) as well as being an integral member of the device development team. The candidate will develop strategies and manage study execution and data generation for applicable milestones including scale up cGMP manufacturing and IND enabling characterization.

  • Partner with external CMOs and internal resources to drive formulation development, technology transfer, and process characterization for a monoclonal antibody-device development program
  • Sit on device development team representing CMC functions
  • Establish and oversee process development strategy and timeline through close partnership and transparent communication with cross functional stakeholders
  • Plan, Design and execute major IND 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
  • Oversee cGMP production including make/assess/release activities as well as ownership and oversight of stability program(s)
  • Ensure that all aspects of Drug Product CMC life cycle management are completed on time, within budget and meet highest scientific, regulatory, quality, and commercial standards.
  • Lead author for applicable regulatory sections in IND submission


Essential Duties and Responsibilities:

  • Subject matter expert in biologics formulation development and cGMP drug product manufacturing
  • In depth knowledge of drug product and combination device development activities
  • Company steward for obtaining the highest product quality, including leading technical discussions and influencing stakeholder acceptance of critical process and quality-based decisions
  • Demonstrates in-depth knowledge of current Good Manufacturing Practices (GMPs)
  • Significant experience and contribution to generation of relevant regulatory sections, data capture and management, process monitoring and trending, including control charting and statistical process control, and supporting regulatory and site inspections
  • 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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