Senior Associate Scientist, Quality Control- Microbiology
Apply NowCompany: Rocket Pharmaceuticals, Inc.
Location: Cranbury, NJ 08512
Description:
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
Desired Competencies:
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.
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
Desired Competencies:
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.