Director, Head of Commercial Manufacturing

Location
San Francisco, CA, United States
Posted
Jan 12, 2021
Ref
978
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
DIRECTOR, HEAD OF COMMERCIAL MANUFACTURING

Position Summary:

The Head of Commercial Manufacturing will be responsible for the commercial production of small molecule pharmaceutical materials, including drug substances and drug products. This role will lead the group to manage the CMOs' manufacturing and QC testing plans and activities.

GBT places a high value on cooperative team dynamics and a positive, "can-do" work ethic. The ideal candidate thrives in a fast-paced environment where a strong sense of urgency is the norm and exceptional communication and interpersonal skills are needed.

Essential Duties and Responsibilities:

  • Provide GBT leadership to the commercial drug substance and drug product manufacturing at the contract manufacturing Organizations (CMOs)
  • Work closely with Supply Chain and Quality on setting production schedules and resource allocations
  • Lead the contract negotiation with CMOs. Work with Legal and Finance to optimize contract terms and to develop the budget planning
  • Maintain healthy working relationship with CMOs to ensure consistent delivery of commercial supplies
  • Monitor KPIs across the CMOs
  • Maintain the GBT records to demonstrate adequate CMO oversight
  • Partner with DS and DP process development groups to implement process improvement for commercial manufacturing
  • Partner with Regulatory and QA to update the regulatory filings as required


Qualifications:

  • BS/BA degree in business, engineering or a related discipline with 10+ years of industry experience with progressive leadership responsibility
  • Excellent cost analysis and planning skills
  • Experience with commercial MSAs and contract negotiations is required
  • Experienced with global commercial marketing, distribution requirement
  • A team player who can fit into different team dynamics internally and externally
  • Strong verbally and written communication skills
  • Working knowledge of Good Manufacturing Practices (GMP) and regulatory requirements on the commercial pharmaceuticals


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.