Principal Scientist, CMC Analytical Development

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🕒 April 1

🏄 California – Remote

🏄 California – Remote

💵 $152.7k - $218.1k / year

⏰ Full Time

🔴 Lead

🧬 Research Scientist

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Akero Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2017

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Akero Therapeutics is a company pioneering novel therapies to transform the lives of people living with serious metabolic diseases. Their flagship program, Efruxifermin (EFX), is aimed at treating metabolic dysfunction-associated steatohepatitis (MASH) and is currently undergoing multiple clinical trials. Akero is committed to advancing medicine in the field of metabolic diseases and has a strong focus on research, development, and clinical studies.

📋 Description

• 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