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Senior Director, Technical Product Leader

Position Summary:

Achaogen is seeking an experienced and highly motivated Technical Product Leader to be accountable for launch and post-launch success of our first product.  The position will lead a cross-functional team tasked with late stage CMC development of a small molecule, supply chain planning & management, contract manufacturing, technology transfers, GMP quality assurance and control, and regulatory compliance.  The Leader will be accountable for exceptional execution of technical operations activities for this initial product launch.  The Leader will identify and advocate for the people and processes needed for a first-time U.S. drug launch.  In addition, the Leader will have a role in coordinating technical activities with commercialization partner(s) outside the U.S.

Achaogen is growing rapidly to support commercialization of a first product as well as deliver an expanding pipeline of potential therapeutics.  The successful candidate will be able to contribute as a senior leader in our Technical Operations organization, play an active role in designing our organization and have the ability to successfully manage function(s) as needed.  The Leader will be experienced in late-stage CMC development and commercial manufacturing, and have built a reputation as a highly sought after functional and/or cross-functional leader. 

Essential Functions:

  • Establish and lead the Technical Product Team (TPT) for the company’s first commercial product.  Key activities coordinated by the TPT will include CMC sections of the NDA, manufacturing process validation, GMP inspection readiness, U.S. supply launch, distribution/warehousing, manufacturing process scale-up, technology transfers, ex-U.S. supply and external commercial manufacturing activities.
  • Partner with functions to establish the business processes, talent and financial resources required for a first product launch.  If a needed function does not yet exist, advocate and drive creation of such function(s).
  • Represent all technical operations aspects of the product to the Lifecycle Core Team and other executive leadership forums as appropriate.
  • Collaborate with functional leaders in development, supply chain, quality, regulatory, and commercial to identify opportunities and remove obstacles.
  • Lead, mentor, and organize a cross-functional team of experts and leaders to ensure key deliverables are met
  • Manage new functions as appropriate when the organization evolves.

 

Preferred Experience:

  • Minimum 15 years of experience in pharmaceutical / biopharmaceutical technical operations
  • Strong technical background in chemistry, chemical engineering, or related discipline.  Expertise in process, formulation or analytical development and/or manufacturing.
  • Significant project and/or functional leadership experience
  • Experience transitioning a small molecule therapeutic from late-phase development through commercialization a plus

Preferred Education:

  • BS, MS or PhD in Chemistry, Chemical Engineering or Related Field.  MBA a plus. 

Preferred Additional Skills:

  • Previous experience in supply chain, logistics, quality operations, quality assurance, quality control and/or regulatory compliance.
  • Excellent verbal/written communication and presentation skills.
  • Independent self-starter, with ability to learn quickly in an unfamiliar area and under minimal supervision.
  • Problem solving and analytical skills, with ability to anticipate problems and recommend solutions.
  • Strong influencing skills with proven ability to negotiate and build consensus.
  • Strong planning, organization, and time-management skills..
  • Collaborative personality to successfully lead and participate in cross-functional teams.
  • Demonstrated success in fast paced entrepreneurial environment.
  • Ability to craft a clear vision and plan despite ambiguity.
  • Experience establishing productive, collaborative relationships with external partners
  • Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
  • Current US work authorization required.
  • Able to travel domestically and internationally.
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