Senior Engineer, Data Analytics
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, MS&T-Data Analytics who will be responsible for process/product data collection, analyses, and monitoring across all phases of GMP manufacturing for cell/gene therapy products. The ideal applicant will have a strong background in statistical methodologies used in the analysis of large manufacturing data sets. 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 data is appropriately trended and analyzed.
Responsibilities:
- Provide leadership in identifying and implementing appropriate statistical methodologies for evaluating all types of CMC data.
- Develop strong cross-functional relationships with analytical development, manufacturing, process development, Quality Control and Quality Assurance to collaborate and align on appropriate statistical methodologies and interpretation of the output.
- Support process and analytical (including stability) data monitoring by summarizing, trending, and presenting data.
- Support the design and implementation of reliable and relevant continuous process verification (CPV) programs.
- Author technical reports summarizing analyses and contribute to relevant sections of regulatory filings.
Qualifications:
- Bachelor’s + 10 years/Master’s +8 years/PhD + 2 years of experience in a technical discipline (biostatistics, engineering, mathematics or similar)
- Experience with using design of experiments (DOE), linear and nonlinear regression, variance component analysis, multivariate analysis, process capability and control charts.
- 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)
- Ability to travel up to 10%
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.
