Associate Director – Drug Product Development

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🕒 April 1

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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

• Design and oversee the execution of development studies to evaluate the optimal formulations and establish scalable, robust DP manufacturing processes. • Partner with CROs and CDMOs to manage drug product activities in preparation for process validation and registration. • Generate high quality data based on sound scientific principles, interpret data and communicate the results through technical reports, presentations, and regulatory documents. • Demonstrate ability to critically evaluate complex analytical and development data and lead troubleshooting of any formulation, process, and manufacturing challenges. • Design and execute in-use compatibility studies to support product use and label. • Author and review drug product sections for regulatory submissions, including original IND/IMPD, IND/IMPD amendments, BLA, and response to queries from global regulatory authorities, Investigator's Brochure and Pharmacy Manual. • Contribute to product quality review forums to define specifications and monitor product performance as measured by quality control testing. • Support clinical and commercial supply planning. • Interact effectively with members within Technical Operations, and cross-functional internal and external partners to ensure alignment of technical activities. • Drive project execution to meet key milestones, timelines, and deliverables.

🎯 Requirements

• Master's degree and 7+ years of experience, or a PhD and 5+ years of experience required • Bachelor's degree from an accredited university with 9+ years of experience, may also be considered • Scientific background in protein formulation and biologics drug product process development for liquid and lyophilized products, and biophysical characterization of proteins • Proven expertise in at least one aspect of drug product development and/or manufacturing processes, including formulation, compounding, aseptic processing, filling, and primary packaging • Work independently to design, execute, and analyze laboratory experiments and interpret results • Willingness to remain actively engaged in hands-on laboratory experimentation is a plus • Experience in CDMO management and collaborating effectively with the Quality Assurance and Clinical Supply Chain teams • Experience preparing CMC sections for BLA submission is desirable • Deep knowledge of FDA, EMA, and ICH guidelines and standards for biopharmaceutical process development and manufacturing • Excellent communication skills (both verbal and written) and interpersonal skills are required • Experience operating in a fast-paced, science-driven environment, rapidly adapting to evolving project needs, priorities, and timelines.

🏖️ 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 sick time policy • Flexible vacation policy • Parental leave policy