Director, CMO Operations

Location
San Francisco, CA, United States
Posted
May 01, 2021
Ref
1098
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
DIRECTOR, CMO OPERATIONS

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

The Director, CMO, Operations will be a member of the cross-functional Chemistry, Manufacturing and Controls (CMC) teams for multiple programs, including one Phase III / BLA enabling large molecule program and one early stage novel first in class large molecule - device combination program. The Contract Manufacturing Organization (CMO) team leader will partner with all functions on the CMC team (Chemical Development, Formulation Development, Analytical Development, Manufacturing, Supply Chain, Quality Assurance, Regulatory Affairs) to oversee the development and implementation of program strategies and comprehensive project plans.

Essential Duties and Responsibilities:

  • Strategy execution owner leading cross-functional team to advance one or more programs through technical development, clinical supply generation, regulatory submissions, and commercialization deliverables
  • Partner with cross functional leaders to develop comprehensive product development and lifecycle management plans for internal and external stakeholders including non-clinical, clinical, CMC, and regulatory
  • Drive cross functional coordination and execution by identifying and managing interdependencies and reducing program risks through action logs, mitigation plans, corrective actions and lessons learned
  • Lead program level risk planning and milestone execution. Maintain overall CMC timelines from process development deliverables through BLA submissions
  • Facilitate cross-functional CMC project team meetings, both internally and with partners/CMOs, and document and communicate key takeaways to relevant constituents
  • Ensure the project information is appropriately communicated, keep clarity and transparency within the CMC team
  • Work with functional leaders and key executives to define requirements, priorities and assumptions, initiate projects and ensure progress on both short, and long-term goals
  • Directs project execution by assigning tasks, tracking project schedules, identifying risks, ad developing and executing contingency plans
  • Sample and documentation tracking ensuring right first-time execution per timelines. Facilitate reviews and remediation as appropriate
  • Support CMC planning for regulatory filings, and create tracker to track status of CMC-related modules
  • Partner with team leaders in interactions with corporate governance bodies to ensure programs have adequate budget and resources to support approved scope


Qualifications:

  • MS or advance degree preferred with a minimum of 8 years of relevant experience for AD and 10 years and for Director
  • 5+ years' experience in GMP environment understanding GMPs and regulatory requirements
  • Knowledge of biologics program development and cGMP manufacturing
  • Regulatory Dossier experience a plus
  • Experience within a CMC function including hands on experience in early to late phase drug substance and drug product development including BLA experience
  • Understanding of ICH guidelines, FDA regulations, and industry best practices
  • Proven project management skills, interacting with external manufacturing organizations
  • Excellent ability to embrace ambiguity and complexity and demonstrate problem-solving leadership with limited oversight; ability to translate complex concepts into actionable, measurable tasks
  • Demonstrated ability to influence outcomes and key project decisions without authority
  • Demonstrated ability to manage and lead others through change
  • Strong knowledge of team dynamics, structure, roles and responsibilities
  • Ability to respond quickly and effectively to changing environments
  • Strong organizational skills and attention to detail
  • Ability to work both independently and in a team focused environment
  • Some US and international travel required (less than 20%)
  • 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
  • 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.