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Vice President, Process and Analytical Development

Posted on Apr 6, 2021 by Asklepios Biopharmaceutical

Durham, NC 27711
Research
Immediate Start
Annual Salary
Full-Time


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
development
Complies with all applicable laws and Company policies regarding health, safety and
environment


About You


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
desirable
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




Reference: 1152691269

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