Akero Therapeutics - Associate Director, Drug Product Development

Remote$153k - $218k2mo ago

Remote Director WW Logistics Manufacturing Associate Director of Product Documentation Reporting Quality Assurance Liquid Quality Control

Requirements

• Bachelor's degree from an accredited university with 9+ years of experience, may also be considered • Scientific background in protein formulation and biologics drug product process development for liquid and lyophilized products, and biophysical characterization of proteins. • Proven expertise in at least one aspect of drug product development and/or manufacturing processes, including formulation, compounding, aseptic processing, filling, and primary packaging. • Work independently to design, execute, and analyze laboratory experiments and interpret results. • Willingness to remain actively engaged in hands-on laboratory experimentation is a plus. • Experience in CDMO management and collaborating effectively with the Quality Assurance and Clinical Supply Chain teams. • Experience preparing CMC sections for BLA submission is desirable • Deep knowledge of FDA, EMA, and ICH guidelines and standards for biopharmaceutical process development and manufacturing. • Excellent communication skills (both verbal and written) and interpersonal skills are required. • Experience operating in a fast-paced, science-driven environment, rapidly adapting to evolving project needs, priorities, and timelines.

Responsibilities

• 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. • Physical Requirement: Ability to travel up to 20%. Internationally and Domestic • Physical Requirement:

Benefits

• Akero Therapeutics, a Novo Nordisk company, offers long-term incentive compensation depending on the position's level or other company factors. • Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy. • The job posting is anticipated to close on April 10, 2026. The Company may however extend this time-period, in which case the posting will remain available on our careers website at https://akerotx.com/job-opportunities.