[Hiring] Associate Director, Drug Product Development @Akero Therapeutics

Role Description

The Associate Director, Drug Product Development, will lead late-stage development activities for EFX within the Technical Operations division. Key responsibilities include:

• Development and characterization of robust, scalable drug product formulations and manufacturing processes.
• Preparation of CMC sections for regulatory submissions and updates.
• Expertise and prior experience in large molecule/biologics drug product development and CDMO management.
• Experience with developing both liquid and lyophilized dosage forms.
• Collaboration with internal and external partners to meet project timelines and objectives.

Relationships:

• This position reports to the Director, Formulation & Drug Product Development.
• Interaction with all areas of CMC and Novo Nordisk.
• Engagement with team members at the IC through Vice President level.
• Experience interacting with senior level positions in each department.
• External engagement with CDMOs.

Job Responsibilities

• Design and oversee the execution of development studies to evaluate 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 results through technical reports, presentations, and regulatory documents.
• Critically evaluate complex analytical and development data and lead troubleshooting of 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 responses to queries from global regulatory authorities.
• 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.

Qualifications

• Master's degree and 7+ years of experience, or a PhD and 5+ years of experience required.
• 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.
• Ability to 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.

Requirements

• Ability to travel up to 20%, both internationally and domestically.

Benefits

• Base compensation range of $152,700 to $218,128, determined based on various factors.
• Eligibility for a company bonus based on individual and company performance.
• Long-term incentive compensation depending on the position's level or other company factors.
• Participation in 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.
• Time off pursuant to sick time policy, flexible vacation policy, and parental leave policy.

Company Description

Akero Therapeutics, a Novo Nordisk company, is a clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need.