Akero Therapeutics

Director

• Design and oversee the execution of development studies to evaluate the optimal formulations and establish scalable, robust DP manufacturing processes.
• Partner with CROs and CDMOs to manage drug product activities in preparation for process validation and registration.
• Generate high quality data based on sound scientific principles, interpret data and communicate the results through technical reports, presentations, and regulatory documents.
• Demonstrate ability to critically evaluate complex analytical and development data and lead troubleshooting of any formulation, process, and manufacturing challenges.
• Design and execute in-use compatibility studies to support product use and label.
• Author and review drug product sections for regulatory submissions, including original IND/IMPD, IND/IMPD amendments, BLA, and response to queries from global regulatory authorities, Investigator's Brochure and Pharmacy Manual.
• Contribute to product quality review forums to define specifications and monitor product performance as measured by quality control testing.
• Support clinical and commercial supply planning.
• Interact effectively with members within Technical Operations, and cross-functional internal and external partners to ensure alignment of technical activities.
• Drive project execution to meet key milestones, timelines, and deliverables.

Associate Director – Drug Product Development

Research Scientist

• Operational oversight of analytical characterization activities within Akero through working closely with our global network of external analytical testing sites and manufacturing partners (CROs/CTLs/ CMOs) and colleagues in R&D, Quality Assurance, and Regulatory.
• Develop and execute analytical heightened characterization studies and comparability assessments
• Oversee phase-appropriate development, validation, and implementation of biologic analytical methods at CRO/CDMOs.
• Work closely with QC on stability trending analysis and elucidation of product degradation pathways and specification setting.
• Collaborate with cross-functional teams to develop CQA risk assessments and mitigation strategies for in-process control and post-licensure monitoring strategies. This includes working closely with downstream and process scientists/engineers to characterize both drug substance and drug product manufacturing processes.
• Support preparation of regulatory submissions and regulatory engagement as technical subject matter expert as needed.
• Monitor advancements and trends in analytical technology and applications in biologics characterization strategies that meets regulatory expectations.

Principal Scientist, CMC Analytical Development

Project Manager

• Oversee and drive CMC project plans, ensuring deliverables align with the overall project objectives and timelines
• Facilitate cross-functional collaboration by leading CMC sub-team meetings, preparing agendas, tracking action items, and maintaining meeting minutes.
• Partner with Technical Operations, Legal, and Finance to negotiate and execute confidentiality agreements, consulting agreements, master service agreements, and work orders with CDMOs and CROs, following internal procedures.
• Oversee development and execution of integrated project plans, including timelines, budgets, and resource allocation across multiple workstreams.
• Partner with Technical Operations, Legal, Finance, and external CDMOs/CROs to negotiate and finalize agreements, ensuring compliance and timely execution.
• Monitor and manage project budgets, forecast resource needs, and provide financial oversight to support decision-making.
• Proactively identify and mitigate risks, maintaining risk registers and implementing contingency strategies to ensure program success.
• Deliver high-quality reporting and communication, including executive-level updates, dashboards, and presentations for governance forums.
• Champion process improvements and best practices, driving operational efficiency and consistency across Technical Operations projects.
• Other responsibilities may be assigned as required by management

Manager, CMC Project Management

QA Engineer

• Provide strategic quality oversight for the intake, investigation, and management of clinical-stage combination product complaints.
• Ensure compliance with global GMP, GCP, and pharmacovigilance requirements.
• Collaborate closely with key stakeholders to ensure timely, compliant investigations, effective CAPAs, and inspection-ready documentation.
• Safeguard patient safety, product quality, and regulatory compliance throughout clinical development.
• Interact with all areas of Clinical, Regulatory Affairs, and Pharmacovigilance.
• Engage with CROs and CMOs for regulatory inspections and audits.

Quality Assurance Manager, Product Complaints

• Provide QA oversight for the planning, execution, and reporting of clinical trials for biologic programs.
• Ensure compliance with ICH-GCP, FDA 21 CFR Parts 50/54/56/312, EMA regulations, and other international clinical trial requirements.
• Support audit readiness of investigator sites, Clinical Research Organizations (CROs), and internal clinical teams.
• Participate in vendor qualification and ongoing oversight of CROs, ensuring compliance with contractual and regulatory obligations.
• Review and manage deviations, CAPAs, and change controls associated with Clinical activities.
• Ensure quality documentation is complete, accurate, and compliant with corporate standards and global regulations.
• Support continuous improvement initiatives across Clinical QA functions.
• Provide quality input into regulatory submissions, including INDs, BLAs/MAAs, and safety updates.
• Serve as a QA liaison between Clinical Operations, Regulatory Affairs, and external partners (CROs, Safety Vendors).
• Support training and awareness of GCP and corporate quality policies across internal teams and contractors.
• Facilitate effective communication between internal stakeholders and global regulatory authorities during audits and inspections.

Associate Director, GCP Quality Assurance

Program Manager

• Own and execute program and portfolio management strategy across Akero’s development organization
• Serve as primary cross functional integrator, ensuring alignment between strategy, execution, governance and decision making across programs.
• Partner with Development Therapeutic Area VPs and senior leaders to advance strategic priorities and ensure clear accountability, ownership, and decision rights.
• Design, implement, and run Akero’s development governance model in alignment with the parent organization.
• Establish and maintain decision-making frameworks, escalation pathways, and executive visibility into risks, trade-offs, dependencies, and outcomes.
• Lead Akero Development governance meetings and ensure consistent alignment with parent company processes and expectations.
• Collaborate with TechOps (CMC) to develop, gain approval, and execute on the project strategy in alignment with parent company
• Lead cross-functional alignment across departments, proactively identifying and resolving risks, conflicts, and misalignments.
• Oversee program timelines, integrated development plans, and delivery of key milestones across the portfolio.
• Manage trade-offs and dependencies, escalating issues to senior leadership as needed to maintain progress and alignment.
• Identify gaps in capabilities, training, and processes (e.g., GCP training), and partner with Quality to support compliance activities as needed.
• Establish scalable systems, templates, tools, and best practices for program and portfolio management.
• Own portfolio-level risk and issue management, ensuring mitigation strategies are proactively developed and executed.
• Monitor program performance and intervene as needed to keep programs on track.
• Partner with Finance and leadership on development budgets, forecasting, and resource allocation across the portfolio.
• Build, mentor, and develop program management talent.
• Organize and deploy project management support across functional areas and programs.
• Foster a high-performing, accountable, and collaborative program management culture.

Associate Director – Drug Product Development

Principal Scientist, CMC Analytical Development

Manager, CMC Project Management

Quality Assurance Manager, Product Complaints

Associate Director, GCP Quality Assurance

Senior Program Director – Regulatory and Clinical Development