Senior Engineer - Drug Product
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 Senior Engineer, Drug Product who will be responsible for technology transfer, process implementation, process validation and technical support across all phases of GMP manufacturing for cell/gene therapy drug products. The ideal applicant will have a strong background in sterile filtration, aseptic fill and finish. The incumbent will support internal manufacturing activities in collaboration with cross-functional department colleagues within Rocket Pharma, as well as engage with external partners, to ensure the successful execution of GMP production.
Responsibilities:
- Provide technical leadership for fill/finish process designs, filling validation, primary/secondary packaging selection and validation, internal/external tech transfer, deviation investigations and change management.
- Act as person in plant (PIP) for key unit operations during critical production campaigns.
- Provide subject matter expertise on drug product 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.
- Lead sterile filtration, container closure integrity, extractables/leachables, and shipping simulation studies in collaboration with external partners and internal CMC colleagues.
- Author 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.
- Provide technical guidance on the design and build out of an internal filling suite.
Qualifications:
- Bachelor’s + 10 years/Master’s +8 years/PhD + 2 years of experience in a technical discipline (cell biology, biochemical/chemical engineering, biotechnology or similar)
- Extensive experience with sterile filtration and aseptic filling of CGT products in vials and bags
- Extensive knowledge of cGMP standards and ICH guidelines across all stages of drug development
- 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, 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.
