Akero Therapeutics - Principal Scientist, CMC Analytical Development
Requirements
• 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).
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 • Physical Requirement:
Benefits
• 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.
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