Senior Scientist, Quality Control- Bioassay

Overview

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.

Position Summary

We are seeking for a Senior Scientist, Quality Control – Bioassay with the responsibility to support clinical and commercial manufacturing of a range of AAV and LVV gene therapy products. 

Responsibilities

• Perform GMP bioassay release and stability testing for AAV and LVV products, requiring experience with some or all of the following analytical platforms or methodologies:
  • Cell-based functional potency
  • Flow cytometry
  • Infectivity
  • In-cell Western/immunocytochemistry
  • Real time and digital PCR
• Document and review analytical data in accordance with good documentation practices.
• Qualify analytical cell banks, reference standards, assay controls, and critical reagents used in analytical methods.
• Validate analytical methods in a manner compliant with ICH Q2(R2).
• Investigate invalid assays and out-of-specification test results.
• Author and review analytical methods, validation protocols, validation reports, CoAs, and SOPs as needed.
• Author and review Quality Management System (QMS) documents (deviations, CAPAs, change controls, gap/risk/impact assessments) as necessary.
• Prepare source documents and compile data sets for Regulatory and CMC teams to support regulatory filings (e.g. IND, BLA)
• Evaluate new technologies for method optimization.
• Assist with analytical equipment and software validation.
• Support day-to-day operations of the lab (e.g. cleaning, logbook curation, equipment calibration oversight)

Qualifications

Education/Experience

• PhD. in Molecular Biology, Cell Biology, or Immunology with 2 years of biotechnology/pharmaceutical industry experience, with a strong preference for QC experience within GMP environment, and with cell gene therapy products; M.S with 8 years or B.S. with 10 years 

Required and Preferred Competencies:

• Hands experience with cell-based functional potency, flow cytometry, infectivity, in-cell Western/immunocytochemistry, and/or real time and digital PCR is required.
• Strong technical writing skills are required.
• Strong analytical skills to troubleshoot and investigate aberrant test results is required.
• Strong interpersonal communication skills are required.
• Ability to work in a fast-paced pharmaceutical GMP environment is required.
• Familiarity with ICH Q2 (R2) and other regulatory documents (e.g. USP, EP, ICH, FDA guidelines) relevant to method validation is preferred.
• Experience with Cell and Gene Therapy (CGT) products in clinical and commercial phases is preferred.
• Leadership experience and project management skills to support a multi-project environment is preferred.

EEO Statement

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.