Principal Scientist, CMC Analytical Development
Akero Therapeutics
full-time
Posted on:
Location Type: Remote
Location: California • United States
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Salary
💰 $152,700 - $218,128 per year
Job Level
About the role
- 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.
Requirements
- 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.
Benefits
- 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
- parental leave policy
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
analytical characterizationmethod developmentmethod transfersantibody characterizationrelease testingstability testingcomparability assessmentsrisk assessmentsregulatory submissionsbiologics characterization
Soft Skills
writing skillsorganizational skillsproblem-solving skillscollaborative skillsmultitaskingproject managementprioritizationcommunication skills
Certifications
PhDBachelor's degreeMaster's degree