Principal Engineer - MS&T - Cell Therapy
Cranbury, NJ /
Manufacturing – Manufacturing Science & Technology (MS&T) /
Full Time
/ Hybrid
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.
We are seeking a Principal Engineer who will be responsible for technology transfer, process implementation, process validation and technical support of late phase and commercial GMP manufacturing activities for ex vivo lentivirus drug products. The ideal applicant will have a strong background in manufacturing of autologous cell therapies. The incumbent will collaborate with cross-functional department colleagues within Rocket Pharma as well as external partners to ensure the successful execution of GMP production.
Responsibilities:
- Provide technical leadership for cell/gene therapy manufacturing process validation, process changes and improvements, external tech transfer, deviation investigations, and change management.
- Interact extensively with contract manufacturing organizations (CMOs) and contract testing organizations (CTOs) to ensure the timely production and release of drug product.
- Act as person in plant (PIP) for key unit operations during critical production campaigns
- Lead systematic root cause investigations that result in timely closure of deviations and ensure implementation of robust solutions.
- Develop strong cross-functional relationships with manufacturing, process development, Quality Control and Quality Assurance to enable effective resolution to technical issues and drive continuous process improvement.
- Perform process monitoring (including summarizing, analyzing, and presenting manufacturing data) and implement/ monitor continuous process verification (CPV) programs.
- Lead authoring and review of manufacturing batch records, process flow diagrams (PFD), tech transfer documents, process performance qualification (PPQ) protocols/reports, CPV protocols and relevant sections of regulatory filings.
- Collaborate with process development, manufacturing, supply chain, and quality assurance in the identification and establishment of requirements/specifications for new and secondary source raw materials.
- Mentor developing MS&T engineers.
Requirements:
- Bachelor’s + 18 years/Master’s +16 years/PhD + 8 years of experience in a technical discipline (cell biology, biochemical/chemical engineering, biotechnology or similar)
- Extensive experience with cell/gene therapy process development and/or manufacturing
- Extensive knowledge of cGMP standards and ICH guidelines across all stages of drug development
- Experience with GMP plasmid production is a plus.
- Excellent attention to detail, communication, time management, organizational skills, and flexible attitude with respect to work assignments/new learning with proven ability to interact in a team environment.
- Comfortable in a fast-paced small company environment with the ability to manage a variety of projects simultaneously and handle rapidly changing information.
- Expert computer skills including MS Office Suite, JMP Statistical Software (or MiniTab) and Visio (or equivalent)
- Ability to travel up to 30%
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.
