Quality Control Scientist - Raw Materials

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

Rocket Pharma is a company bringing hope and relief to patients with undertreated rare diseases through the development and commercialization of curative first-in-class gene therapies. We are seeking a Quality Control Scientist with expertise in Raw Materials testing, to support clinical manufacturing of a range of AAV and LVV Gene Therapy products. 

Responsibilities

• Perform QC inspection and release of Raw Materials according to Rocket’s procedures
• Perform various analytical tests (HPLC, UV, IR/FTIR,  ELISAs, Western Blot, qPCR) of Raw materials
• Support testing of process development samples
• Establish/Transfer new assays in QC laboratories
• Optimize and validate assays for raw materials testing
• Assist in planning and executing laboratory studies
• Evaluate new technologies for bioassay method optimization
• Author and review technical documents (protocols, reports, SOPs, test methods, memos, and Impact Assessment)
• Work with cross-functional peers to meet company’s deadlines
• Perform QC data review, generate CoAs and all related QC documents for QC release of products in accordance with Rocket’s procedure
• Assure that all required QC records (testing, methods, protocols, reports, and raw data) are generated and approved
• Train and assist Junior QC associates in their functions

Qualifications

• M.S. Chemistry, Biology or Immunology with 5 years of industry experience or BS in Biology, Immunology with 10 years of relevant experience in QC or equivalent experience in the biotechnology industry
• Preferred experience with Gene/Cell therapy products for clinical and commercial
• Ability to work independently and make decision
• Expertise in method validation
• Experience with mammalian cell culture
• Knowledge of FDA guidelines on method development/validation and/or ICH analytical procedures
• Experience in AAV or other viral vectors and Lenti Viral Vector for gene therapy is highly preferred
• Ability to interact, cooperate and motivate across departments and functions
• Effectively works in a fast-paced pharmaceutical environment with prior start-up experience preferred
• Handle issues appropriately and with a sense of urgency
• Possesses a positive, can-do attitude and creatively solves problems

Compensation

The expected salary range for this position is $95,000 to $118,000.

At Rocket, our compensation philosophy and ranges are built upon data and insights collected from validated world-class providers. We are committed to compensating employees equitably based on several factors, including responsibilities and level of the position, depth and types of the employee’s experience, location of the position and availability of similar talent in a competitive market.

For U.S.-based candidates, this is an at-will position, and Rocket reserves the right to adjust the range at hire or during the year due to market shifts.

In addition to base salary, Rocket offers a competitive total rewards package that may include bonuses (short-term incentives), medical, dental, and vision insurance, life insurance, 401(k) with company match and generous vesting, paid vacation and holidays, global shutdown days between Christmas and New Year’s, and a variety of wellness resources and employee support programs. Also, certain positions are eligible for added forms of compensation, such equity awards (long-term incentives).

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.

Salary : $95,000 - $118,000