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Director Antibody Process Development & In-Vitro Diagnostics Project Team Leader at Achaogen
South San Francisco, CA, US
Position Summary:

Achaogen is seeking an experienced and highly motivated leader to fill two key roles in the company. Each position will take approximately 50% of the leader’s time:



Project Team Leader (PTL) of a late-stage in-vitro diagnostics (IVD) project utilizing immunoassay technology. The PTL will be accountable for aligning project vision, strategy and resources. The IVD project strategy is closely tied to plazomicin, Achaogen’s lead product candidate. It is also tied to strategic business partners. The PTL will rapidly respond to the dynamic needs of a late-stage project, including strategic assessment of risk mitigation and scenario planning. The PTL will be an exceptional influencer and communicator with an ability to align diverse perspectives from scientists, regulators, subject matter experts, consultants, senior management, and business partners. The PTL will be highly flexible to step into resource gaps as needed in addition to ensuring the team is composed of the appropriate resources.



Director of Antibody Process Development. Achaogen’s therapeutic antibody efforts are focused on developing monoclonal antibodies that are attractive as antibacterial agents. This newly created position will partner closely with Research and Product Development to establish Achaogen’s capabilities in therapeutic monoclonal antibody process development and manufacturing. The Director must be highly strategic and have deep technical knowledge of antibody process development. The Director will establish the appropriate mixture of internal capabilities and strategic partnerships.



Essential Functions:

IVD PTL

Strategic leadership of the IVD project team.
Communicating and influencing key stakeholders, both internally and externally.
Structuring and leading a team that successfully delivers all aspects of the IVD program, including assay validation, clinical utility, regulatory approval and commercialization.
Anticipate challenges to timeline, delivery, quality or financials; mitigate and respond to project risks.
Timely, clear communication to key stakeholders, including the plazomicin Project Team and Executive Committee.


Director Antibody Process Development

Partner with the Therapeutic Antibody group in Research on antibody production strategies for discovery and early development.
Create a strategic vision for establishing internal and external process development and GMP manufacturing capabilities. Gain endorsement for the strategy from senior leadership.
Create a resource plan (people, money, space) with timelines in alignment to anticipated therapeutic antibody project deliverables.
Lead execution of the resource plan through hiring, building and/or establishing partnerships.


Preferred Experience:

Minimum 15 years of experience in biopharma, diagnostics and/or medical devices.
Deep technical knowledge in process development and manufacturing of therapeutic antibodies.
Significant project and/or functional leadership experience.
Experience leading both technical and business aspects of a project and/or function.


Preferred Education:

BS, MS or PhD in Life Sciences, Engineering or Related Field. MBA a plus.


Preferred Additional Skills:

Expertise with in-vitro diagnostics, particularly for Therapeutic Drug Monitoring.
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.