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Senior Technical Operations Director
Posted on 3/14/2023
San Bruno, CA, USA
Experience Level
Desired Skills
  • Bachelors degree in biological sciences or related field with minimum of 15 years demonstrated experience in a pharmaceutical setting. Advanced degree is preferred (MS/PhD)
  • Hands-on experience with large molecule drug substance and drug product manufacturing processes, as well as clinical packaging and distribution
  • Demonstrated a track record of building relationships with vendors, suppliers, and contract organizations effectively
  • Ability to deliver in a fast-paced, small company environment and the tenacity to seamlessly adjust workload based upon changing priorities
  • Ability to mentor and lead both directly and through influence
  • Excellent communication skills, including the ability to influence cross-functionally and articulate complex issues clearly to drive understanding and decision-making
  • Experience developing and managing projects and budgets to plan
  • Thrive in an environment where work is accomplished both independently and by teams
  • Understanding of ICH, FDA, and USP guidelines in phase-appropriate pharmaceutical development
  • Outstanding ethics and integrity
  • Salary Range:
  • Drive pharmaceutical development activities for drug substance, drug product, and clinical trial materials throughout development
  • Continuously assess and communicate the manufacturing status for multiple programs across a global CDMO network
  • Develop and manage the BLA enabling CMC activities for lead clinical programs
  • Manage internal and external interactions with quality and regulatory organizations to ensure the timely resolution of technical issues
  • Author regulatory submissions to planning and respond to technical queries received from global health authorities
  • Assess CMO and supplier performance to plan while also developing phase appropriate contingency strategies
  • Represent CMC operations across internal and external project teams
  • Grow partner relationships for co-developed programs and support partnering due diligence efforts for preclinical to clinical assets
  • Identify and assess new technologies and contractors to support manufacturing requirements

51-200 employees

Company Overview
Alector is combining state-of-the-art antibody technology and recent discoveries in neuroimmunology and human genetics to develop novel.