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Senior CMC Project Manager

Position Summary:  

This position will provide technical project management of CMC activities for Achaogen’s small and large molecule development pipeline.  Partnering closely with the CMC team leader and cross-functional stakeholders the CMC Technical Project Manager will apply both technical and project management fundamentals to develop CMC strategy, execution plans, contingencies, timeline, budget, resourcing, etc. from early development through commercial launch.  The successful candidate will liaise with subject matter experts through both formal team structures and informal interactions to translate critical stakeholder input into business deliverables, and to drive decision-making and alignment within the team. 

The successful candidate will welcome Achaogen’s exciting dynamic environment, high potential pipeline, and rapidly evolving needs and priorities, leveraging a growth mindset to adapt focus, contribute where needed, and ultimately collaborate to progress projects through the development lifecycle.  Candidates with a strong technical background who are interested in further developing team leadership skills, who enjoy a breadth of experience, and importantly, who are passionate about the development, and commercialization of innovative antibacterials to treat multi-drug resistant (MDR), gram-negative infections should apply.

Essential Functions:

  • Manage CMC team activities for from early development through commercial launch in partnership with the CMC team leader.
  • Manage development of team deliverables for program execution and project governance in collaboration with the CMC team leader and subject matter experts including process development, analytical development, formulation, supply chain, CMC regulatory to achieve project goals on time and within budget.
  • Facilitate strategy development and decision-making by leveraging technical and development lifecycle knowledge, facilitating divergent/convergent decision-making processes, managing conflict, and seeking critical input from team leadership, SMEs and stakeholders.
  • Own and maintain project management tools (minutes including decisions and actions, timeline, budget, risk management, resource management) that support but do not supersede program strategy development and execution success.  Align with PMO on portfolio level communication and use of project management tools. 
  • Facilitate and manage productive team communication and collaboration, both internally and externally.

Preferred Experience:

  • 7+ years technical experience in large or small molecule drug development.
  • Minimum of 2 years of project management or team leadership experience in drug development, with demonstrated knowledge of project management fundamentals.
  • Experience in drug development through commercial approval a plus.

Preferred Education: 

  • B.S/M.S. in Engineering, Chemistry, Biochemistry, Microbiology or related technical discipline
  • MBA preferred.

Preferred Additional Skills:

  • Demonstrated ability to develop strong cross-functional working relationships.
  • Excellent communication and presentation skills.
  • Strong business acumen and strategic agility driven by solid analytical thinking.
  • Prior direct management experience a plus.
  • Effectively able to synthesize key insights from various sources and drive decisions.
  • 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.
  • 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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