Vice President, Process and Analytical Development
StrideBio is a product-driven, fully integrated gene therapy company focused on creating and developing innovative genetic medicines with life-changing or curative potential for patients with devastating conditions, including monogenic rare disease and beyond.
We leverage our proprietary structure-inspired adeno-associated virus (AAV) vector engineering platform (STRIVE) to create unique and differentiated vectors that improve upon naturally occurring AAV serotypes to overcome current limitations of first-generation gene therapies. Combined with our genetic construct design expertise and in-house manufacturing capabilities, StrideBio is positioned to generate best-in-class genetic medicines that allow more patients to benefit with maximum efficiency, leading to improved treatment outcomes.
Our team is comprised of accomplished leaders and talented, passionate colleagues with a desire to translate innovative science into treatments. Together with our collaborators we are making rapid progress on our mission to bring novel medicines to patients who desperately need them. StrideBio's offices, labs and manufacturing facility are located in the heart of Research Triangle Park, NC, within 10 miles of downtown Durham and Raleigh-Durham International Airport. Please visit www.stridebio.com to learn more.
MUST have pharma and/or biotech industry experience.
In this new role reporting to the COO, we need your demonstrated leadership capabilities and strategic acumen to lead a Process Development, Analytical Development, and research production organization from early stage pre-clinical discovery development through late stage clinical manufacturing and process validation. You will be a critical contributor to the overall company development and growth path going forward, underpinning the strategy and commitment to bring novel AAV Capsid therapy treatments to patients utilizing StrideBio's proprietary Strive technology. Your leadership, technical, strategic, and operational expertise in rAAV process and analytical development, including cell culture development, purification development, formulation development and analytical development, will equate to success.
- Elaborate and execute the Company's strategy for developing the rAAV manufacturing and analytical processes required for StrideBio's gene therapy products and partnered product candidates utilizing the AAV capsid Strive technology.
- Provide leadership to the Process and Analytical Development teams, including, hiring, mentoring, developing and day-to-day staff management.
- Assist the Pre-clinical and Platform discovery research functions in the development and identification of lead vector capsids and expression cassettes.
- Ensure that the processes are developed from an early stage through the late stage requiring the establishment of qualified/validated methods for transfer, the establishment of Critical Process Parameters (CPP's), Critical Quality Attributes (CQA's) and Critical Material Attributes (CMA's). Directs the development of required plans, protocols, and studies to be in place to support the successful optimization and technical transfer of developed manufacturing and analytical processes to internal/external facilities in charge of manufacturing StrideBio's cell and gene therapy products.
- Benchmarks to best practices in industry to provide robust, compliant, scalable, and efficient, cost effective GMP manufacturing processes.
- Coordinate the timely supply of research materials from the Research Production group to supply research materials for pre-clinical studies, Platform and Discovery research.
- Directs the sourcing of critical raw materials. Assures that identified vendors can maintain a robust supply chain and meet phase appropriate GMP requirements. Oversees the development of specifications for critical raw materials, intermediate components, and in collaboration with Quality and CMC, and regulatory groups final product release testing.
- Oversees the preparation of Standard Operating Procedures, Test Specifications and Master Batch Records in support of process development, cGMP manufacturing and analytical testing needs
- Development and execution of the expense and capital budget requirements on a yearly basis and monthly review on the execution of the budget.
- Maintain alignment of goals and deliverables with internal stakeholder functions (such as Platform and Discovery research, Pre-clinical, clinical, and Quality) as well as external partnered programs.
- Work with the Chief Operating Officer to develop excellence in a progressive continuous improvement culture of rigor and safety in all development operations.
- Assures departmental compliance with all regulatory, financial and safety regulations at a state and federal level.
- Sets ambitious, tangible, and measurable targets and then takes personal responsibility for achieving team results in a fast-paced and vigorous schedule.
KNOWLEDGE AND SKILLS:
- The ideal candidate will be a seasoned professional, with the ability to balance strategy and tactical needs and know when a "hand`s on" approach may be required.
- PhD in relevant scientific field; or MSc in scientific field - education in molecular biology, gene therapy and/or viral vector development and manufacture. A minimum of 15 years of experience in biologics or cell/gene therapy manufacturing in industry, with progressive proven experience in vector (AAV) manufacturing and analytical development activities for both early stage development and later stage development (focus on QbD - driven development activities of manufacturing/analytical processes).
- Demonstrates strategic capability and business acumen.
- Capability to build strong relationship with internal and external stakeholders.
- The successful candidate will be a self-starter with experience in effectively hiring, mentoring, developing and leading reports into becoming a high-performance work team.
- Good understanding of practical challenges in the development of rAAV vector pre-clinical and GMP manufacturing.
- Solid knowledge of FDA's and EMEA's requirements for GMP manufacturing of cell therapies.
- Solid understanding of cleanroom technology and aseptic manufacturing conditions.
- Creative at finding ways to get the job done; thriving in challenging environments and finding ways to remove obstacles to meet timelines.
- Understanding of the analytical development process and steps to assure the transfer of robust qualified methods to internal/external manufacturing facilities.
- Flexible mindset capable to manage change and deal with ambiguity. Flexibility to re-prioritize workload to meet changing timelines, adaptability.
- Sound organizational and time management skills
- Autonomous, pro-active personality. Driven to achieving highest results in shortest timeframe.
- Efficient in planning and executing work: orchestrate multiple activities at once.
- Capacity to manage priorities
- The ability to travel domestically and internationally (app. 20% of the time)
COMPENSATION & BENEFITS:
We offer a competitive salary and excellent benefits package including:
- Stock Options and Bonus
- Medical, Dental, and Vision health insurance
- Matching 401k plans (both Pre-tax and Roth Post-tax)
- Life/AD&D, Long-term and Short-term disability
- Employee Assistance Program
- Voluntary: Supplemental Life, Critical Illness, Group Accident, Hospital Indemnity, Identity Theft Protection
Additionally, we provide the following perks:
- Relocation Services
- Retail Member Discount Programs
- Complimentary onsite gym membership
- Fully stocked kitchen
- Socials, happy hours, and other events throughout the year (currently "virtual")