Associate Director Product and Device Development

Company Background
Akero Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. Our current focus is on advancing our lead program efruxifermin (EFX) to provide a powerful new treatment for patients with NASH, a disease for which there are currently no marketed therapies.

We are a team of problem solvers dedicated to pursuing bold scientific approaches to build a brighter future for patients. Our diverse skill sets and backgrounds, desire to learn from each other and collaborative spirit breed a culture where everyone feels inspired to bring their best thinking to work, and to bring out the best in others.

Job Summary
Akero’s Associate Director Drug Product and Device Development reports to the Vice President, Product and Device Development and will provide broad-based support for the technical transfer and clinical manufacture of lyophilized drug product at our Contract Manufacturing Organization (CMO) located in Europe. Actual level, title, and compensation will be commensurate with education and experience.

Job Responsibilities

• Provide technical support of drug product process transfer and clinical manufacture of lyophilized sterile injectable biopharmaceuticals from late-stage development through commercialization
• Support Drug Product process characterization and process validation studies at external CMO
• Establish and implement phase-appropriate Drug Product development concepts and standards in a resource- and cost-effective manner
• Ensure high-quality vendor management, meeting company standards and industry regulations for biopharmaceutical products; serve as person in plant as needed during critical operations
• Provide scientific pharmaceutical development support for Efruxifermin and other subsequent projects at various stages of development
• Develop strategy and logistics for projects and technology transfers in support of process improvements and new product introductions
• Use sound scientific and engineering criteria to evaluate manufacturing processes, identify and execute process optimization strategies, and ensure successful manufacturing of sterile injectable biologics
• Execute programs and prepare documentation to support key regulatory milestones such as preparation and submission of INDs, BLA, PAI, and fulfilment of post marketing commitments
• Provide both strategic and detailed engineering/technology support for development and pre-marketing production of Drug Product
• Participate in CMC and cross-functional development teams, as required, including due diligence of potential acquisition candidates

Technical Requirements & Skills

• Protein therapeutics experience in all aspects of drug product development, clinical manufacture, and drug delivery, in addition to helping manage external vendors and oversee outsourced activities
• Working knowledge of drug/medical device combination products and human factors studies for self-administration of injectable biologics is a plus
• Functional knowledge of formulation development and analytical techniques for the characterization of biopharmaceuticals
• Knowledge of international pharmaceutical guidance, regulations, drug development process, and industry standard practices
• High proficiency in written, oral, and interpersonal communications in English, including with senior management, health authorities, and internal and external partners
• High attention to detail; ability to organize, prioritize, and delegate assigned projects
• Exceptional influencing, partnership, and collaboration skills
• Able to prospectively identify potential problems and to partner effectively and positively to solve issues
• Proficient use of standard MS Office suite (eg, Word, Excel), experience using electronic document management systems and document review tools desirable
• Ability to self-start in a virtual organization, influence effectively in videoconference-based project team meetings, ability to engender shared commitment with CMO-CRO for delivering on agreed objectives

Qualifications

• 10 + years’ biotechnology industry experience with successful BLA/MAA submissions
• Broad hands-on exposure to multiple injectable drug delivery technologies and dosage forms including development and/or significant optimization/robustness of drug product formulations
• Working knowledge of CMC regulatory requirements for biopharmaceutical products in various stages of development as well as practical application of principles of quality by design (QbD)
• Direct relevant experience in drug product development and commercialization in US, EU, ROW
• Experience in lyophile technical transfer and scale up for sensitive biologics as well as GMP requirements for sterile injectables
• Experience outsourcing manufacturing/development activities at CMO/CROs
• Excellent oral and written communication skills
• Advanced degree (M.S./Ph.D.) in relevant scientific discipline, e.g. Chemical/Bio Engineering, Protein Chemistry, Biological Sciences, Pharmaceutical Sciences