Principal Scientist, CMC Analytical Development

Job Summary

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, and 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. This position requires a knowledge of key state of 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. 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

• Operational oversight of analytical characterization activities within Akero through working closely with our global network of external analytical testing sites and manufacturing partners (CROs/CTLs/ CMOs) and colleagues in R&D, Quality Assurance, and Regulatory.
• Develop and execute analytical heightened characterization studies and comparability assessments
• Oversee phase-appropriate development, validation, and implementation of biologic analytical methods at CRO/CDMOs.
• Work closely with QC on stability trending analysis and elucidation of product degradation pathways and specification setting.
• Collaborate with cross-functional teams to develop CQA risk assessments and mitigation strategies for in-process control and post-licensure monitoring strategies. This includes working closely with downstream and process
• scientists/engineers to characterize both drug substance and drug product manufacturing processes.
• Support preparation of regulatory submissions and regulatory engagement as technical subject matter expert as needed.
• Monitor advancements and trends in analytical technology and applications in biologics characterization strategies that meets regulatory expectations.
  
  

Physical Requirement:  Ability to travel up to 15%. Internationally and Domestic

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.
• Must be familiar 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).

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 10th. 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.