Senior Associate Scientist, Quality Control- Microbiology
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 an Senior Associate Scientist, Quality Control – Microbiology with the responsibility to support clinical manufacturing of a range of Gene Therapy products. Technical proficiency in analytical methodology for drug substances and drug products is required for gene-based products.
Responsibilities:
- Perform routine testing (microbial and molecular) of samples for release and stability
- Ability to develop testing protocols and qualification procedures for Environmental Monitoring
- Perform Environmental Monitoring and other Microbiology related activities
- Perform Subculturing and Identification for recovered Microorganisms
- Support analytical testing of process development samples as applicable
- Ability to develop qualification method for analytical testing
- Working knowledge of regulatory guidelines (USP, FDA, Annex-1, etc.)
- Support general QC labs operations and functions
- Document test execution according to cGMP, maintains up to date QC records, logbooks and notebooks
- Lead lab investigations, CAPA and Change Control records
Qualifications:
Education/Experience and Skills Requirements:- BS in Biology, molecular biology, virology, Life Sciences or equivalent
- BS + 3 - 5 years of relevant experience in QC or equivalent experience in biotechnology industry
- Preferred experience with Gene/Cell therapy products for clinical and commercial
- Ability to work independently and troubleshoot issues
- 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
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.