South San Francisco, CA, United States
Jun 25, 2020
**MEMBERS ONLY**SIGN UP NOW***. Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. We are combining the precision of gene regulation with the versatility of gene therapies to create breakthrough treatments. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit ****The position of Scientist of Analytical Development, Protein Chemistry & Biophysics, will lead the development, optimization and qualification of analytical methods for AAV vector QC release testing, stability testing and product characterization. The ideal candidate will have hands-on experience in protein analytical and biophysical assays. The position requires close and effective collaboration with internal (R&D, PD, QC, QA, Manufacturing and Facilities) and external parties (CRO, CDMO).
Develop, optimize and qualify biophysical and protein chemistry analytical methods for QC release and stability testing of AAV drug substance and drug product.
Design and perform analytical characterizations to understand AAV product critical quality attributes (CQA) and support process development.
Provide expertise and testing results from methods such as IEX, RP-HPLC, AUC, DLS, SEC, SEC-MALS, AF4 (FFF), CE-SDS, Mass Spec, Sub-visible & visible particles, Spectrophotometry, pH, Osmolality etc. to support process development of AAV products.
Author technical reports and SOPs and contributes to relevant sections of regulatory filings if needed.
Collaborate with QC to transfer and/or qualify key release or in-process methods
Conduct lab testing, train analysts, analyze data, and review results
Operate under Good Documentation Practice for efficient data management and retrieval
Keep current with advances in analytical methodologies; evaluate, assess risks, and recommend new technologies that will be useful in expanding and enhancing process and product understanding
Support investigations and CAPAs as required
Maintain a safe, clean, well-organized testing lab, ensuring that equipment is in calibration and good operational condition
Support tech transfer activities to Contract Manufacturing Organizations (CMOs) if required
Comply with safety and other company policies
PhD in a relevant area of specialization plus 2 years of industry experience OR
MSc/BSc in a relevant area of specialization plus 8 /11 years of industry experience
Hands-on experience of analytical method development and qualification under ICH/FDA guidelines and a general understanding of instrumental IQ/OQ/PQ
Demonstrated history of working independently, with minimal supervision, and managing multiple projects
Sense of urgency and enthusiasm for collaboration
Demonstrated success and desire to work with a diverse team in a fast-paced environment under challenging timelines
Strong attention to detail supported by excellent time management and organizational skills
Strong communication and interpersonal skills
Proficiency with MS Office (Excel, PowerPoint, Word)
Comprehensive benefits package, including competitive employer premium contributions
Meaningful stock option grants
PTO, sick time and holiday pay
Generous Parental Leave program
Pre-tax medical and dependent care programs
STD, LTD, Life and AD&D
Professional development opportunities
Fully stocked kitchen
Purple Tie dry cleaning service