Manager, CMC Project Management

COMPANY BACKGROUND

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. Our current focus is on advancing our lead program efruxifermin (EFX) to provide a powerful new treatment for patients with MASH(metabolic dysfunction-associated steatohepatitis).
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.

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

The Project Manager will lead CMC-related projects within the Technical Operations ensuring timelines, budgets, and deliverables are met. The candidate will report to CMC project management and provide support to budgeting, as needed. This role requires strong organizational skills, proactive communication, and the ability to manage multiple priorities. The Project Manager will own small-to-medium projects independently and contribute to larger, cross-functional initiatives with increasing autonomy. The ideal candidate will have experience with CMC development within a biotechnology or pharmaceutical company in late-stage clinical development or near commercialization.

 

Relationships: 

Reports to the Sr Director, CMC Project Management.

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

• 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

 

 

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

 

Qualifications

• BS degree required.
  • Degree in life sciences/engineering strongly preferred, professional certifications (i.e. PMP) will be a distinct advantage
• 4+ years of experience supporting Technical Operations (Manufacturing, Analytical/QC testing, Packaging, Distribution)
  • Device Development experience highly desired
• Excellent communication skills (both verbal and written) and interpersonal skills are required
• Works well independently as well as in a team environment
• Highly proficient in Microsoft Office applications and Smartsheet; comfortable and quick learner with other software systems
• Demonstrates collaborative communication and problem-solving spirit.
• Willingness to do what needs to be done in a dynamic environment.

 

The base compensation range for this position is $120,300 to $222,600. 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 March 13th. 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.