Associate Director/Director of Analytical Development
300 Trade Center, Woburn, MA 01801, USA
Job Description
Sanegene Bio is a privately held, well-funded, fast-growing biotechnology company focusing on small nucleic acid research. Founded in 2021 with headquarter in Cambridge, MA, and research centers in Woburn, MA and Suzhou, China, Sanegene Bio is built upon cutting-edge RNA delivery innovations to treat human diseases.
The CMC team is seeking experienced oligonucleotide analytical development talent to establish and grow Sanegene Bio’s CMC analytical development capabilities.
Core Responsibilities:
- Build and lead Sanegene’s analytical development team to support Sanegene’s fast-growing siRNA pipeline
- Develop phase appropriate analytical strategies for key raw materials, in-process samples, drug substances and drug products
- Contribute to the overall CMC strategy to support Sanegene’s discovery, pre-clinical, and clinical programs
- Identify and work with appropriate CROs, CDMOs, and consultants to meet program timelines
- Spearhead analytical development, method qualification/validation, method transfer efforts at internal or external labs (CROs/CDMOs)
- Manage quality control, release testing, and stability study activities at internal or external labs (CROs/CDMOs)
- Author and review SOPs, training documents, analytical/stability protocols/reports, analytical section of CMC documents
- Ensure completion of key analytical deliverables to support overall project timelines
Job ID Reference
1621
Desired Skills & Experience
Qualifications and Skills
- PhD. in analytical chemistry or 7+ years of experience under related industry setting
- Direct experience in analytical development function supporting oligonucleotide and/or oligonucleotide conjugates programs
- Experience in analytical development under biopharmaceutical industry setting, familiar with phase appropriate analytical method development, qualification, and validation
- Excellent knowledge a variety of analytical techniques with a focus on oligonucleotide DS/DP, including IPRP-UHPLC, IEX-HPLC, SEC, LCMS, MS/MS sequencing, GC, ICP-MS, Karl Fischer, etc.
- Familiar with ICH stability studies
- Understanding of CMC analytical requirements for IND enabling studies as well as late phase programs
- Working experience in managing AD/QC activities at CROs and CDMOs as well as working with industrial consultants
- Demonstrated ability to work collaboratively in a cross-functional / multi-disciplinary CMC team
- Strong verbal and written communication skills
- Demonstrated team building and leadership skills
- Experience with oligonucleotide therapeutics preferred
Company
300 Trade Center, Woburn, MA, USA
Sanegenebio is a fast-growing small nucleic acid pharmaceutical company. Founded in 2020 with headquarter in Cambridge, MA but relocating to Woburn, MA, Sanegenebio is built upon cutting-edge RNA delivery innovations to treat human diseases. The growing pipelines focus on several strategic areas including liver diseases, central nerve system (CNS) disorders, and cancer.
We offer highly competitive salaries and employee benefits. We value everyone’s idea and voice to make Sanegenebio a better place to work. We keep an open environment to facilitate our employees’ professional learning and career growth.
Workplace
300 Trade Center, Woburn, MA 01801, USA
