Vice President, Technical Development

Rocket Pharmaceuticals•Cranbury, NJ

About The Position

Create a future where DNA is no longer destiny. Join Rocket Pharma. Rocket Pharma is a fully integrated, late-stage biotechnology company advancing gene therapies with curative potential for patients with rare and life-threatening diseases. We are a team of creative, compassionate, and driven individuals united by a profound mission of seeking gene therapy cures. Rocket places tremendous value on our people and fosters a collaborative environment where bold ideas thrive and every team member makes a meaningful impact. Our core values guide everything we do: we trust one another, show generosity toward patients, embrace curiosity, and strive to elevate science. Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits. Position Summary The Vice President of Technical Development is responsible for leading the analytical development, QC Cell-based methods, 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 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.

Requirements

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.

Nice To Haves

Experience with tech transfer and working with CDMOs is highly desirable.

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 development, QC cell-based methods, 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.