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Associate Director, Cell Line Development & Rapid Research Material Production

 

Position Summary:  

This Associate Director, Cell Line Development (CLD) and Rapid Research Material Production will lead the development optimization, and execution of two key Research and Early Development stage activities (1) rapid large molecule expression to support lead optimization and candidate selection within Achaogen’s development pipeline and (2) stable cell line development for lead candidates entering pre-clinical assessment through end of product lifecycle.  The Associate Director will be a champion of innovation to ensure cell line development and rapid antibody production leadership, building strong cross-functional relationships within Research, within CMC, and with external partners.  The successful candidate will welcome Achogen’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 Early Development.

Essential Functions:

  • The Associate Director will leverage the state of the art to develop CLD and research material production technologies, practices and infrastructure to align with Achaogen’s strategic development goals. 
  • Specifically:  Champion the evaluation, recommendation, approval, implementation, and management of CLD and rapid research material production capabilities within Achaogen.
  • Champion build/buy vs. borrow analysis for cell line development.  Analysis includes assessment of contract development and manufacturing organizations (CDMOs), licensed technologies, and other avenues for development of CLD capabilities. Recommendations will be made inclusive of technical, timeline, and financial considerations, and will align with Achaogen’s strategic priorities.
  • Lead the design, development, and characterization of cell lines for the clinical and commercial manufacture of recombinant protein products to meet and exceed productivity, stability and product quality requirements.
  • Build in-house capabilities and/or provide oversight of CDMO in the development of stable expression systems, transfection of host cell lines, and evaluation of production cell banks in compliance with regulatory requirements. 
  • Build in-house capability for the production of research material to enable lead optimization and selection via transient expression systems and stable pools; contribute at an execution level when needed. 
  • 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 of 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:

  • Strong theoretical understanding of and practical experience with the state of the art in the relevant scientific disciplines: molecular biology, cell biology, microbiology, biochemistry, cell culture, and purification techniques for the creation and characterization of recombinant cell lines suitable for clinical and commercial manufacturing, and for rapid expression and purification of small quantities of recombinant proteins (CHO preferred).
  • Expert knowledge in regulatory requirements related to cell line 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.
  • 8-15 years technical experience in the pre-clinical/clinical phase of biopharmaceutical development.
  • Minimum of 2 years of cross-functional team leadership or management experience.

 Preferred Education: 

  •  B.S, M.S., or PhD in molecular and cell biology or related field.

 

Preferred Additional Skills:

  • Familiarity with contract work plans, scope and timeline management to engage CMO/CTLs.
  • 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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