Vice President, Technical Development jobs in United States
cer-icon
Apply on Employer Site
company-logo

Rocket Pharmaceuticals · 1 week ago

Vice President, Technical Development

Rocket Pharmaceuticals is a fully integrated, late-stage biotechnology company advancing gene therapies with curative potential for patients with rare and life-threatening diseases. The Vice President of Technical Development is responsible for leading analytical development, QC methods, and product development functions, ensuring compliance with regulatory standards while delivering cell and gene therapy programs from research through commercialization.

BiotechnologyGeneticsHealth CarePharmaceutical
check
H1B Sponsor Likelynote

Responsibilities

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
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
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
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
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
Develop and manage the overall development budget and resource plan
Allocate resources effectively to meet project timelines and objectives
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

Qualification

Gene therapyProcess developmentAnalytical developmentRegulatory complianceStrategic planningProject managementLeadership skillsTeam developmentTech transferCommunication skillsCritical thinkingCollaboration

Required

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

Preferred

Experience with tech transfer and working with CDMOs is highly desirable

Benefits

Bonuses (short-term incentives)
Medical, dental, and vision insurance
Life insurance
401(k) with company match and generous vesting
Paid vacation and holidays
Global shutdown days between Christmas and New Year’s
A variety of wellness resources and employee support programs
Equity awards (long-term incentives)

Company

Rocket Pharmaceuticals

twittertwittertwitter
company-logo
Rocket Pharmaceuticals is a biotech company that develops a pipeline of genetic therapies for rare childhood disorders.

H1B Sponsorship

Rocket Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2023 (2)
2022 (1)
2020 (1)

Funding

Current Stage
Public Company
Total Funding
$891.36M
Key Investors
RTW InvestmentsCalifornia Institute for Regenerative Medicine
2023-09-12Post Ipo Equity· $175M
2022-10-03Post Ipo Equity· $100.3M
2021-08-30Post Ipo Equity· $26.4M

Leadership Team

leader-logo
Gaurav Shah
CEO and President
linkedin
leader-logo
Jonathan Schwartz
Chief Scientific and Gene Therapy Officer
linkedin
Company data provided by crunchbase