Senior Associate Scientist, QC- Contract
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:
Senior Associate Scientist, Quality Control will be responsible for supporting clinical manufacturing in a range of Gene Therapy products. Technical proficiency in analytical methodology for drug substances and drug products is required for gene based products.
Responsibilities:
- Experience in execution of assays by HPLC and CE-SDS
- Experience in operation of q-PCR/ddPCR, Capillary Electrophoresis
- Perform routine testing of vectors and raw materials for release and stability
- Support analytical and process development activities
- Support general QC labs operations and functions
- Document test execution according to cGMP, maintains up to date QC records, logbooks and notebooks
- Review protocols, data summaries, reports for stability studies and validation
- Assist with deviation, lab investigations, CAPA and Change Control
Qualifications:
- MS or BS in Biology, molecular biology, virology, Life Sciences or equivalent
- BS +5 or MS + 2 years of relevant experience in QC or equivalent experience in biotechnology industry
- Preferred experience with Gene/Cell therapy products for clinical and commercial
- Excellent organizational skills
- Ability to work independently with excellent problem-solving skills
- Thorough knowledge of cGMPs (CFR/ICH/EU) and applicable international regulations and guidelines as they apply to drug manufacturing and aseptic processing
- Experience in AAV, and Lenti Viral Vector for gene therapy is highly preferred
- Ability to interact 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.