Vice President, Process and Analytical Development
Asklepios BioPharmaceutical, Inc. (AskBio) is a privately held, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy pioneers, Jude Samulski, PhD, and Xiao Xiao, PhD. We are driven to change lives with every clinical advancement and turn hope into cures with new possibilities for genetic medicine. We currently have clinical trials ongoing for late-onset Pompe disease and congestive heart failure.
AskBio is headquartered in Research Triangle Park, North Carolina, a thriving biotechnology hub, and has additional research and development facilities in Edinburgh, Scotland, and gene therapy manufacturing in San Sebastian, Spain.
We are excited to have an opening for a VICE PRESIDENT OF PROCESS AND ANALYTICAL DEVELOPMENT to join the AskBio team!
About the Role
The Vice President, who reports to the Chief Technology Officer, will provide technical, operational and strategic leadership and expertise in the development, tech transfer, manufacturing support and CMC operations of rAAV gene therapy products. Serve as the head of the rAAV vector process and analytical development organization, which includes cell culture development, purification development, formulation development and analytical development.
Responsibilities and Accountabilities
- Oversees all process and analytical development efforts for AskBio
- Drives development, optimization and implementation of manufacturing processes and test methods including characterization assays for pre-clinical and clinical stage programs
- Ensures that the scope of all process and analytical development activities is aligned with non-clinical, clinical, CMC (cGMP manufacturing, Quality Control, Quality Assurance), and corporate timeline and budget requirements
- Establishes plans and protocols to develop, troubleshoot, oversee and support efficient
technology transfer of modified/optimized manufacturing processes and analytical methods to Viralgen and internal GMP manufacturing team to support clinical programs
- Identifies sources of critical raw materials, identifies activities or events that may critically affect supply chain and act on that information. Assures that suppliers are meeting stage-appropriate GMP standards. Develops appropriate specifications for critical raw materials, intermediate components, and in collaboration with clinical, CMC and regulatory groups final product release testing
- Oversees all aspects of job-related experimental design, protocols and interpretation of results, recording of data/results, reports, and effective communication of such with stakeholders, including work products from other team members
- Establishes (and benchmarks to best practices in industry) robust, compliant, scalable and
economically feasible GMP manufacturing processes. Perform COGS analyses and risk
assessments (quality, robustness, operability)
- Assists in preparing manufacturing master batch record and test method batch record in collaboration with Viralgen and internal GMP/QC teams
- Oversees the writing of Standard Operating Procedures (SOPs) to support process development, cGMP manufacturing and analytical testing needs
- Provides technical and strategic input and drives continuous improvement to the manufacturing process and analytical methods through technological innovation to support ongoing product development effort by conducting appropriate tests, experiments and qualification studies to justify proposed changes
- Assists in preparing regulatory filing documents and provides responses to questions from U.S.
and ex-U.S. health authorities as Subject Matter Expert (SME) in process and analytical
- Complies with all applicable laws and Company policies regarding health, safety and
- A PhD in chemical engineering, biochemical engineering, biochemistry or other relevant discipline and a minimum of 10 years of progressively responsible experience in gene therapy/vaccines/complex biologics process development roles
- Experienced with development and CMC of rAAV gene therapy products, as well as working knowledge in molecular biology aspects and gene therapy analytical aspects
- In-depth technical and regulatory understanding of GMP biologics manufacturing, as well as applicable international regulations and standards in all phases of product development and commercialization
- Demonstrated experience building and leading high performing teams with the desire and ability to work in a fast-paced environment
- Understanding of cellular processes and metabolism
- Thorough knowledge of AAV manufacturing process and analytical development, cGMP manufacturing, process automation, technology transfer and clinical supply management
- Experience interacting with non-clinical, clinical, quality control, quality assurance and
regulatory affairs departments
- Solid knowledge of regulatory requirements. Must have working knowledge of pharmaceutical
GMP’s and ICH guidelines
- Knowledge of laboratory and clean room operations and aseptic processing requirements
- Demonstrated troubleshooting skills with the ability to “think outside the box”
- Thorough understanding and working experience with Quality by Design (QbD) is highly
- Ability to effectively interact with vendors, colleagues and work well in teams
- Detail oriented with proven organization and project management skills
- Demonstrated ability to work efficiently with different personalities and styles and prioritize activities based on ambiguous or quickly changing information and environments is critical
- Ability to multitask among multiple projects and teams and work independently in a fast-paced, highly interactive environment
- Excellent interpersonal skills with the ability to interact effectively with people, internally and externally, is required
Live an AskLife™
We offer a competitive total rewards package. Are you our next great discovery?