Vice President, Technical Development and CMC Operations - Cranbury
Overview:
Work at ROCKET PHARMA and help cure rare diseases!
Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline.We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator.
In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.
Position Summary:
The Vice President of Technical Development and CMC Operations is responsible for leading the analytical, process, and product development functions. This executive is responsible for developing the overall technical strategy and innovation roadmap, transferring analytical methods and processes to internal and external Quality Control and manufacturing groups, integrating the cross-functional development projects, authoring regulatory documents, identifying and mitigating CMC risks, aligning with health authorities on registrational studies and approach, and supporting the manufacture and testing of clinical and launch supplies.
This individual is accountable for delivering Rocket’s cell and gene therapy programs from research through commercialization. This executive also oversees the CMC leads assigned to support the Global Product Teams and as the deputy to the CTO is responsible for partnering with multiple functional leads to orchestrate timely completion of complex deliverables across the entire technical operations organization and at external parties.This individual will lead the development of strategy, objectives, timelines, resource plans, and budgets. The ideal candidate will have a strong technical background in late-stage/commercial cell and gene therapies, biologics, or related fields, and possess exceptional leadership, strategic planning, communication, and project management skills.
Responsibilities:
Strategic Leadership:
- Develop and implement strategic plans for product development, analytical development, and manufacturing to support the company's gene therapy pipeline.
- Collaborate with executive leadership to align departmental goals with company objectives and regulatory requirements.
Integrated Product Development and Life-Cycle Management:
- Lead the analytical, process, and product development functions.
- Lead the design and execution of process and analytical development plans, including preclinical and clinical development stages.
- Oversee the development and optimization of gene therapy vectors, formulations, and delivery methods.
- Ensure robust process development, scale-up and validation for manufacturing processes, adhering to regulatory guidelines and quality standards.
- Guide the development, validation, and implementation of analytical methods for gene therapy products.
- Ensure the accurate and timely characterization of gene therapy products, including potency, purity, and stability testing.
- Oversee analytical support for regulatory submissions and interactions with regulatory agencies
- Identify opportunities for team synergies and/or product improvements across different platforms.
Product Supply Strategy:
- Oversee the development of the critical raw materials (cell banks, plasmids, reference standards, etc.) and support the product supply strategy, including the assessments for in-house or outsourced production activities.
- Ensure compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.
- Manage the tech transfer process and scale-up of manufacturing processes for clinical and commercial production.
- Develop and maintain relationships with Contract Development and Manufacturing Organizations (CDMOs) and other external partners.
Team Leadership and Development:
- Build and lead high-performing teams in project management and CMC leadership.
- Foster a culture of innovation, collaboration, and continuous improvement.
- Provide mentorship, guidance, and career development opportunities for team members.
Regulatory and Quality Compliance:
- Ensure all development and manufacturing activities comply with regulatory standards, including FDA, EMA, and other global regulatory agencies.
- Collaborate with the Quality Assurance team to implement and maintain quality systems and documentation.
Budget and Resource Management:
- Develop and manage the overall development budget and resource plan.
- Allocate resources effectively to meet project timelines and objectives.
Collaboration and Communication:
- Function as a key liaison with internal and external stakeholders, including research and development, clinical, regulatory, and commercial teams.
- Represent the company in interactions with regulatory agencies, industry conferences, and scientific meetings.
Qualifications:
- Advanced degree (Ph.D. or equivalent) in a relevant scientific discipline (e.g., molecular biology, biochemistry, biotechnology).
- 15+ years of experience in the biotechnology or pharmaceutical industry, with a focus on late-stage/commercial gene therapy, biologics, or related fields.
- Proven record of leading process development, analytical development, and CMC teams.
- Extensive knowledge of regulatory requirements and quality standards for cell and gene therapy products.
- Strong strategic planning, project management, and critical thinking skills.
- Excellent communication, leadership, and people skills.
- Experience with tech transfer and working with CDMOs is highly desirable.
EEO Statement:
A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.