We are seeking a motivated temporary Development Associate to support the development of analytical methods for Adeno-associated virus (AAV) gene therapy products. In this role, the candidate will follow SOPs; perform, troubleshoot, and help optimization of the analytical methods to support a variety of company’s therapeutic programs. The ideal candidate will have a fundamental understanding of developing analytical methods that are used for characterization of manufacturing of biologics.
Support of our process development
Rapid turn around
This is in Gene therapy
Will look at Graduates with 1-2 yrs experience
Reports to Snr Manager and AD up to Senior Director
Growing this team
Amazing science technology
Most people wont have but if they DO- it would be SUPERB: TCID50
They do rotation schedule in lab for Covid safety
- Play a major role in analytical testing for supporting process development under the general supervision of a senior level scientist.
- Assist in development and optimization of novel analytical methods for the characterization of AAV-based drug products.
- Work with senior level scientist to ensure required documentation is accurate and complete.
- Contribute to the completion of milestones associated with specific project plans.
- Contribute to routine laboratory organization of samples and reagents and maintenance of lab equipment
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- BS in a Chemistry, Molecular Biology, Biochemistry or equivalent. MS preferred.
- Minimum 2 years of relevant industry experience.
- Proven laboratory experience with different molecular biology techniques including and not limited to real-time qPCR and droplet digital PCR.
- Familiarity with analytical biochemistry and protein-based assays including ELISA and HPLC.
- Previous experience in a gene therapy-based drug development and regulated environment is a plus.
- An understanding of USP/ICH guidelines for analytical method development, qualification/validation is strong plus.
- Ability to execute experiments independently, troubleshoot molecular techniques and evaluate data of moderate complexity.
- Detail-oriented, organized with ability to work independently and collaboratively.
- Demonstrated ability to document procedures and results and keep accurate detailed records.
- Effective communication and interpersonal skills.
- Ability to be flexible in a fast-paced and dynamic environment.
- Proficient in standard computer skills, familiarity with data analysis and Statistical analysis software is a plus