We are looking for a Sr. Scientist with extensive experience in HPLC, Mass Spectrometry based assays, analytical method development, qualification, and data handling to support gene therapy, antibody, protein/enzyme replacement therapy, small molecule, and/or oligo programs.
- Lead analytical method development, qualification, transfer, and product characterization activities for biologics portfolio (gene therapy, antibodies, enzymes, proteins) in CMC development including managing CDMO interactions and driving the development and implementation of overall analytical control strategy.
- Support pre- and post-IND regulatory submission by authoring and reviewing analytical sections and responding to queries from regulatory agencies.
- Develop and optimize chromatography-, capillary-, spectroscopy-, and mass spectrometry-based analytical methods.
- Prepare, review, and approve analytical and technical reports.
- Document experiments, data, and findings electronically in an accessible manner for inspections.
- Participate in the general lab and instrument maintenance.
- Supervise and mentor team of scientist(s) and research associate(s).
Experience: (Required Skills)
- Solid understanding of CMC enablement of biologics drug development.
- Expertise with the current analytical techniques for pharmaceutical development such as LC-MS, various HPLC modes: SEC, IEX, RP, HILIC and detections, GC-FID/MS, ICP-OES/MS, etc.
- In-depth experience in mass spectrometry platforms: MALDI-TOF MS, QQQ, qTOF, LUMOS, Fusion, etc.
- Experience developing drug substance (DS), drug product (DP) assays and supporting formulation development.
- Extensive experience leading analytical activities in DS/DP development with experience across both early and late phases.
- Deep understanding of product characterization requirement from early to late-stage development with firm knowledge of ICH guidelines & regulatory expectations from US, EU, JAPAC, etc. health authorities.
- Experience in authoring, reviewing regulatory submission (IND, INDa, BLA/MAA).
- Excellent scientific and business communication skills (verbal, written, and presentation), strong interpersonal/collaboration skills, and planning skills.
- Prior experience with people management. Strong problem-solving skills with sound technically driven decision-making ability.
- Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment.
- Experience leading/managing CMC activities. Potential to serve as CMC Analytical Partner Team Leader for early and/or late-stage products.
- Experience managing projects at CROs/CDMOs.
- Knowledge of biophysical characterization techniques specifically focused on gene therapy.
- Knowledge of analytical development for synthetic molecule drugs (e.g., small molecule, Oligo).
PhD degree in Biology, Chemistry or related field with 5+ years of relevant post-graduate experience for Sr. Scientist I (or) 7+ years for Sr. Scientist II.