Associate Director, Drug Product Development

Job Summary

The Associate Director, Drug Product Development, will lead late-stage development activities for EFX within the Technical Operations division. Key responsibilities include, but are not limited to, the development and characterization of robust, scalable drug product formulations and manufacturing processes, as well as the preparation of CMC sections for regulatory submissions and updates. The role requires expertise and prior experience in large molecule/biologics drug product development and CDMO management. The ideal candidate will have experience with developing both liquid and lyophilized dosage forms. The candidate will work with internal and external partners to meet project timelines and objectives.

Relationships: 

This position reports to the Director, Formulation & Drug Product Development 

The position will interact with all areas of CMC. In addition, CMC within Novo Nordisk.  The position interacts with team members at the IC through Vice President level.  The position requires experience interacting with senior level positions in each of these departments and a good understanding of how these peer teams operate, ideally through experience working within these teams (broad experience).

Externally, the position will engage with CDMOs.

Job 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

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.
• 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. 

The base compensation range for this position is $152,700 to $218,128. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.  

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.

EEO Statement:

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.