Senior Manager, Project Management- CMC

Location
South San Francisco, California
Posted
Jul 17, 2018
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

The Senior Manager, Chemistry, Manufacturing and Controls (CMC) Project Management will be a member of the CMC team and will partner with the Scientific Technical Lead and other senior leaders in the development and implementation of CMC project strategies and comprehensive project plans. This role will report to the Senior Director, Project Management.

Role Responsibilities:

  • Facilitate CMC-related project team meetings, both internally and with partners/CMOs, and document and communicate key takeaways to relevant constituents
  • Maintain positive working relationship with CMOs
  • Build fully integrated project schedules capturing all manufacturing activities and resources needed to deliver against corporate goals 
  • Facilitate definition, review and approval of additional Scopes of Work at CMOs
  • Identify critical topics that should be brought to other team members/meetings
  • Assist CMC leadership with management of the CMC budget by monitoring actuals to plan and forecasting
  • Support CMC planning for regulatory filings worldwide
  • Partner with team leaders in interactions with corporate governance bodies to ensure programs have adequate budget and resources to support approved scope
  • Monitor project progress and identify risks and opportunities to timeline, budget or scope

Qualifications:

  • Advanced degree in the Life Sciences (PhD strongly preferred) with a minimum of 8 years of Project Management experience in drug developments
  • Experience within a CMC Function or group with hands on experience in late phase drug product development or with complex manufacturing development processes
  • Experience working with small molecule therapeutics 
  • Proven project management skills
  • 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%)