Senior Manager, CMC Program Management

Location
San Francisco, CA
Posted
Oct 05, 2019
Ref
692
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
SENIOR MANAGER, CMC PROGRAM MANAGEMENT

Position Summary:

This program management position will support the large molecule Inclacumab CMC development Team with an aggressive development plan from IND submission through BLA filing. This is a high priority, highly visible program with a fast paced and innovative CMC development plan. The Project Manager is accountable for ensuring operation excellence and alignment internally and externally with our Contract Manufacturing Organization (CMO) partners. The Program Manager will be responsible for managing the day-to-day activities of the Biologics CMC team and will be accountable to the head of Program Management, with a responsibility to the Biologics CMC Lead to manage critical path activities and risks, as well as to assist in the development of contingency plans, and to manage overall project planning, cross-functional team meetings, and the development of updates and presentations for management. This role requires the ability to develop and maintain strong collaborative and cooperative working relationships with team members across different functions and at different levels within the organization.

Essential Duties and Responsibilities:
  • Manage a high-priority, biologics CMC program with a focus on supporting the CMC Product Development Team with development of the overall program strategy
  • Build fully integrated project schedules (Gantt chart) capturing all manufacturing activities and resources needed to deliver against corporate goals in partnership with CMC leads and functional representatives. Plan, monitor project progress, and identify risks and opportunities to timeline, budget or scope
  • Continually evaluate critical path activities to identify potential ways to accelerate timelines and mitigate risks. Manage and drive the various parts of the timeline with the sub-teams
  • Lead the development, implementation, and update of Project Development Plans which define the scope of project team deliverables
  • Support clinical and potential commercial drug supply
  • Effectively manage cross-functional project team meetings, both internally and with partners/CMOs, including the scheduling of meetings, the preparation of agendas, the development of meeting minutes, document and communicate key takeaways to relevant constituents and the follow up on action items using effective PM tools and systems
  • Work closely with cross functional department heads and team members to ensure all CMC deliverables and activities are aligned across other functions and facilitate communication to ensure clarity and transparency
  • Identify critical topics that should be brought to other team members/meetings. Ensure the project information is appropriately communicated, keep clarity and transparency within the CMC team
  • Facilitate cross functional working groups to resolve highly complex operational issues or improve department processes
  • Proactively identify program risks and work with the team to conduct risk assessments and define appropriate mitigation plans, reflected in the maintenance of a project risk log. Support escalation to senior leaders in collaboration with the project lead
  • Responsible for the preparation of monthly dashboard reports
  • Partner with team leaders in interactions with corporate governance bodies to ensure programs have adequate budget and resources to support approved scope
  • Support CMC planning for regulatory filings, including creation of trackers to track status of CMC-related modules and drive deliverables to completion
  • Promote a culture of collaboration, cooperation, cross functional inclusion, execution excellence, effective communication and cross-functional problem-solving to become a high-performing team
  • Inspire through actions
  • Coach and mentor team members, as required
  • Continuously update knowledge of industry pipeline and competition in disease areas of interest to GBT

Qualifications:
  • Bachelor's degree in biology or chemistry; advanced degree in the life sciences desirable (e.g., MS, MBA, MD, PhD)
  • 5+ years biologics DS/DP manufacturing and development, commercial experience a plus
  • 5+ years project and lifecycle management experience in the Biotech industry. PMP certification a plus\
  • Experience in pharmaceutical development, including broad knowledge of the drug development process including industry best practices and FDA stage goals for stage I/II/III validation. Biologics development experience preferred
  • Strong project management skills with experience utilizing PM tools and methodology including organizing, prioritizing, planning, and executing multiple projects from definition through implementation and completion
  • Strong, analytical, quantitative and creative problem-solving skills
  • Ability to be effective in both the strategic and tactical aspects of product development
  • Proven effective interpersonal, organizational, and written and verbal communication skills with the ability to effectively interact with all levels of the organization and with external stakeholders
  • People leadership experience preferred including the ability to earn the trust of team members and management
  • Demonstrated ability to confidently work under pressure and concurrently manage multiple responsibilities
  • Able to travel up to 25% of the time

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.