[Hiring] Principal Scientist, CMC Analytical Development @Akero Therapeutics

Role Description

The Principal Scientist supports analytical development and characterization activities for late-stage biologic development leading to licensure application submission. The successful candidate will work closely with cross-functional teams across CMC to take a leading role in analytical characterization activities in support of:

• Comparability studies
• Heightened characterization studies
• Method development
• Control strategy development
• CQA risk assessment
• Other late-stage biologic development activities relating to analytical development

This position involves authoring and reviewing of technical reports needed for regulatory filings and participation in the drafting of regulatory documents, including IND/IMPD/BLA.

The successful candidate is expected to have a strong technical expertise in analytical characterization for protein biologics development, with knowledge of key state-of-the-art heightened characterization methodologies and their applications for protein pharmaceutics.

Relationships:

• This position will report to the Director, Analytical Development, CMC or VP, Analytical Science and Quality Control.
• The position will interact with all areas of CMC, including Novo Nordisk.
• Engagement with team members at the IC through Vice President level.
• Experience interacting with senior level positions in each of these departments.
• External engagement with CDMOs.

Qualifications

• PhD and 5+ years of experience required.
• Bachelor's degree from an accredited university and 9+ years of experience, or master's degree and 7+ years of experience may also be considered.
• In-depth understanding of antibody structure and function and technical expertise in antibody characterization, release, and stability testing.
• Experience in method development and method transfers into QC.
• Experience/knowledge in cGMP, ICH, and regulatory guidelines.
• Experience in authoring global regulatory filings and responses to questions is a plus.
• Knowledge of analytical methods used in in-process clinical drug substance and drug product manufacture.
• Excellent writing, organizational, and problem-solving skills.
• Demonstrated ability to work collaboratively with cross-functional teams to achieve shared goals.
• Proven ability to multitask and manage multiple projects or deliverables simultaneously and prioritize tasks in a fast-paced environment.
• Experience managing projects with remote teams and through external alliances preferred.
• Familiarity with Microsoft Office productivity software such as Word, PowerPoint, and Excel.
• Past experience using statistical and scientific software such as MiniTab, Origin, or JMP is a plus.
• This position is for remote work and will require some domestic and/or international travel as required (applicants must have valid travel documents).

Requirements

• Ability to travel up to 15%. Internationally and Domestic.

Benefits

• Base compensation range for this position is $152,700 to $267,300.
• Eligible 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 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
• Voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance, and auto/home insurance
• Time off pursuant to its 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.

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.