Associate Director – Drug Product Development
Akero Therapeutics
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $152,700 - $218,128 per year
Job Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
protein formulationbiologics drug product process developmentbiophysical characterization of proteinsformulationcompoundingaseptic processingfillingprimary packaginglaboratory experimentationCMC sections preparation
Soft Skills
excellent communication skillsinterpersonal skillscritical evaluationtroubleshootingproject executionindependent workcollaborationadaptabilitydata interpretationtechnical reporting
Certifications
Master's degreePhD