Achaogen is seeking an experienced and highly motivated Director, CMC Team Leader to be accountable for project leadership and management for small and large molecule programs from early development through launch. The position will lead cross-functional teams tasked with CMC development, including process development, analytical development, quality, compliance, clinical manufacturing, CDMO management, and regulatory filings, as well as CMC related launch preparation and launch readiness activities. The Leader will be accountable for exceptional execution of technical operations activities, and will identify and advocate for the people and processes needed for CMC drug development scope.
Achaogen is growing rapidly to support an expanding pipeline of potential therapeutics. The successful candidate will be able to contribute as a leader in our Technical Operations organization, and have the ability to successfully manage multiple teams as needed. The Leader will be experienced in CMC development, clinical manufacturing, and have built a reputation as a highly sought after cross-functional team leader and program manager. Overall, the expectation for this role is of impactful matrix leadership, communication, and delivery of the portfolio.
● Oversees CMC related team leadership and project management activities for programs from early stage development to launch. Sets strategic direction for projects.
● Represent all technical operations aspects of the product to the Development Core Team and other executive leadership forums as appropriate. Serves as the primary liaison between Development Core Team, leadership, and project team members. Collaborate with functional leaders in research, development, supply chain, quality, regulatory, and commercial to identify opportunities and remove obstacles.
● Ensures development and oversees execution of integrated project plans including milestones, timelines, resources and budgets.
● Accountable for availability of clinical supplies, timely and complete submission of regulatory filings and development of robust manufacturing processes and analytical methods within a “matrix” structure.
● Accountable for selection and effective collaboration with external development and manufacturing partners.
● Proactively develops and manages project timeline, risks, and resources. Drives project related decision to ensure teams are successful in achieving their goals and team milestones.
● Author and review of relevant sections of regulatory filings, interact with global regulatory agencies.
● Thrive in the presence of ambiguity, and to both leverage existing and develop new skills and knowledge to meet program needs as they arise.
● Minimum 10 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.
● Demonstrated knowledge of project management fundamentals.
● Experience in drug development through commercial approval a plus.
● 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.
● Familiarity with contract work plans, scope and timeline management to engage CMO/CTLs.
● 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. Effectively able to synthesize key insights from various sources and drive decisions.
● Strong business acumen and strategic agility driven by solid analytical thinking.
● Strong influencing skills with proven ability to negotiate and build consensus.
● Strong planning, organization, and time-management skills..
● Collaborative approach to successfully lead and participate in cross-functional teams.
● Demonstrated success in fast paced entrepreneurial environment.
● 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
● 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.