VP, Engineering (Biotech) with a Gene Therapy Company – San Diego, CA

JRG Partners LLC4 months ago
San Diego, CA, United States
On-site
Full-time
Junior Level (1-3 years)

Job Description

Position Overview

JRG Partners is proud to partner with a pioneering, clinical-stage gene therapy company based in the vibrant biotech hub of San Diego, CA. Our client is at the forefront of developing transformative treatments for rare and life-threatening genetic diseases, driven by cutting‐edge science and a commitment to patient-centric innovation. We are seeking a visionary and highly accomplished Vice President of Engineering to join their executive leadership team. This pivotal role is responsible for providing strategic direction and technical leadership across all engineering functions—including Process Development, Manufacturing Sciences and Technology (MS&T), and Facilities/Equipment Engineering—in support of their groundbreaking AAV-based gene therapy platform.

Key Responsibilities

  • Strategic Leadership & Vision – Develop and execute a comprehensive engineering and technology roadmap that aligns with the company's long-term strategic goals. Provide executive leadership and oversight for Process Development, MS&T, and Facilities Engineering departments while fostering a culture of innovation and continuous improvement.
  • Process Development & Optimization – Lead teams responsible for late-stage process development, characterization, and validation for viral vector (AAV) manufacturing; optimize both upstream (cell culture, transfection, viral production) and downstream (purification, chromatography, filtration) processes to enhance yield, purity, and scalability.
  • Technology Transfer & Manufacturing Support – Direct the successful technology transfer of manufacturing processes to internal cGMP sites and/or external CDMOs, serving as the primary technical liaison to ensure seamless execution and troubleshooting during manufacturing campaigns.
  • Manufacturing Sciences & Technology (MS&T) – Build and lead a best-in-class MS&T function to support clinical and commercial manufacturing, including process monitoring, data trending, and root cause analysis to maintain process robustness and product consistency.
  • Regulatory & Compliance Oversight – Ensure all engineering activities and manufacturing operations adhere to the highest quality and compliance standards, contribute to regulatory filings (IND, BLA, MAA), and serve as a subject matter expert during inspections and interactions with health authorities.
  • Team Development & Mentorship – Recruit, mentor, and develop a high-performing team of engineers and scientists, cultivating a collaborative and inclusive environment that champions career growth.
  • Capital Projects & Facilities Management – Oversee strategy, design, and execution of capital projects including facility expansions, equipment acquisition, and technology implementation to support pipeline growth and commercial readiness.
  • Budget & Financial Management – Develop and manage the annual operating and capital budgets for the engineering organization, ensuring prudent resource allocation in support of corporate objectives.
  • Cross-Functional Collaboration – Partner closely with Quality, Regulatory Affairs, Research, Clinical Operations, and Program Management to align technical strategies, mitigate risks, and communicate progress to the executive team and board.

Required Qualifications

  • Education: An advanced degree (M.S. or Ph.D.) in Chemical Engineering, Biochemical Engineering, Bioengineering, or a related scientific discipline is required.
  • Experience Required: A minimum of 15 years of progressive experience in the biopharmaceutical industry, including at least 8 years in a senior leadership role overseeing process development, manufacturing sciences, or engineering functions.
  • Gene Therapy Expertise – Direct, hands-on experience with the development and manufacturing of viral vectors, preferably AAV, with a deep understanding of the unique challenges associated with gene therapy CMC.
  • Requirements: Extensive experience operating in a cGMP environment with a strong grasp of global regulatory requirements (FDA, EMA) and a proven track record of successful regulatory submissions (INDs, BLAs).
  • Technical Proficiency – Demonstrated expertise in process scale-up, technology transfer, process characterization (utilizing QbD principles), and process validation for biologics.
  • Leadership Skills – Exceptional leadership, communication, and interpersonal skills with a proven ability to build, lead, and motivate high-performing technical teams in fast-paced, entrepreneurial environments.

Preferred Qualifications

  • Experience taking a product from late-stage clinical development through to commercialization.
  • Experience managing both internal manufacturing operations and external CDMO relationships.
  • Strong business acumen with demonstrated long-range planning, budgeting, and resource management capabilities.
  • A reputation as a thought leader in the gene therapy community with an extensive network of professional contacts.

Benefits & Perks

  • Compensation: A highly attractive base salary, annual performance-based bonus, and a significant equity package (stock options/RSUs).
  • Comprehensive Health & Wellness – Full medical, dental, and vision insurance for you and your dependents, along with robust wellness programs including gym memberships and mental health resources.
  • Retirement Planning – A 401(k) plan with a generous company match.
  • Work-Life Balance – Generous paid time off (PTO) policy encompassing vacation, sick leave, and company holidays.
  • Relocation Assistance – A comprehensive relocation package available for exceptional candidates moving to the San Diego area.
  • Professional Growth – Ample opportunities for professional development, including attendance at major industry conferences and leadership training programs.
  • Innovative Culture – The chance to work in a dynamic, collaborative, and science-driven environment where your contributions directly impact patients' lives.

Required Skills

Regulatory & Compliance Oversight
Facilities Engineering
Process Development
Team Development & Mentorship
Strategic Leadership
Manufacturing Sciences & Technology (MS&T)
cGMP Compliance
Capital Projects & Facilities Management
Technology Transfer
Process Optimization
Cross-Functional Collaboration