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Associate Director, Large Molecule Analytical & Formulation Development

Position Summary:  

We seek a highly motivated individual for the position of Associate Director for Large Molecule Analytical and Formulation Development.  This individual will lead a team responsible for physiochemical characterization of large molecules and formulation development activities to support development of biotherapeutics from lead optimization through late-stage clinical trials and commercialization.

The Associate Director will be a champion of innovation to ensure phase-appropriate, risk-based, cost-effective analytical and formulation development plans, and build strong cross-functional relationships within Research, CMC, and with external partners.  The candidate will build in-house capabilities to enable method development, formulation screening, and troubleshooting, and will work with CDMOs/CROs for development, transfer, and qualification of methods for clinical development.  The successful candidate will welcome Achaogen’s dynamic environment, high potential pipeline, and rapidly evolving needs and priorities, and act as a key strategic partner to advance Achaogen’s large molecule drug candidates into and through Early and Late Development.

Essential Functions:

  • The Associate Director will leverage the state of the art analytical technologies to support .Achaogen’s strategic development goals with the large molecule pipeline. 
  • Specifically: Lead the overall scientific, technical, and operational aspects of product characterization for Research and Early Development.
  • Build capabilities in molecular characterization to enable a fast to clinic development strategy.
  • Develop and implement analytical development-specific development plans and timelines.
  • Establish internal capabilities and tools for rapid product characterization to enable development activities and troubleshooting; maintain accountability for execution using these capabilities and tools.
  • Collaborate internally to enable understanding of the impact of molecular attributes on product safety and efficacy.
  • Manage assay transfer to and from other groups within Achaogen and external partners.
  • Working closely with CDMOs, lead the formulation development efforts and associated analytical and clinical manufacturing activities.
  • Review CDMO reports and other development- related documents in support of CMC sections for regulatory submissions.
  • Champion build/buy vs. borrow analysis for analytical and formulation development.  Analysis includes assessment of contract development and manufacturing organizations (CDMOs) and other avenues analytical development capabilities. Recommendations will be made inclusive of technical, timeline, and financial considerations, and will align with Achaogen’s strategic priorities.
  • Establish an internal laboratory group as appropriate, including management of direct reports.
  • Work effectively within a matrixed organizational structure, establishing strong working relationships with key stakeholders not limited to Research, CMC, external manufacturing partners. 
  • Author and review relevant sections of regulatory filings; interact with global regulatory agencies.
  • Able to thrive in the presence of ambiguity, and to both leverage existing and develop new skills and knowledge to meet program needs as they arise.

Preferred Experience:

  • 10+ years relevant experience in the biotechnology industry in the pre-clinical/clinical phase of biopharmaceutical development.
  • Proven leadership abilities to hire, manage, empower and mentor analytical scientists at all levels.
  • Extensive experience and independently proficient with a variety of analytical techniques for biotechnology product characterization, including HPLC/UPLC, mass spectrometry, and other analytical methods.
  • Knowledgeable of global regulations and industry standards for testing and characterization of biologics, including cGMP guidelines.  Direct experience with CMC analytical and formulation regulatory requirements at different phases of development.
  • Demonstrated ability to drive for results and lead innovation and change.
  • Demonstrated collaborative leadership success in both project and people management and technology development and transfer.
  • Collaborative, team oriented leadership and management style.
  • Strong oral and written communication skills.
  • Expertise in the applicable regulatory requirements, US and OUS.
  • Minimum of 2 years of cross-functional team leadership or management experience.

 Preferred Education: 

  • PhD in chemistry/biochemistry or related scientific or engineering field; B.S. or M.S. and extensive experience will be considered.

Preferred Additional Skills:

  • Familiarity with contract work plans, scope and timeline management to engage CDMO/CROs.
  • Strong business acumen and strategic agility driven by solid analytical thinking.
  • Effectively able to synthesize key insights from various sources and drive decisions.
  • Proficiency with MS Office, MS Project, quality system databases, electronic document management.
  • Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
  • Current US work authorization required.
  • Ability to travel domestically and internationally.
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