In this role, you will apply your knowledge of protein chemistry and expertise in cellular and molecular biology to characterize therapeutic proteins, cell and gene products. Act as Analytical Project Leader, you will closely interact with clients and manage projects from initiation to successful completion.
Roles and Responsibilities:
- Independently develop and apply biochemistry, biophysics methods, immunoassays, and other state of the art analytical technologies to analyze and characterize oligonucleotides, cell and gene products, biotherapeutic proteins, their conjugates, and variants.
- Perform method development, validation, tech transfer, product characterization, impurity profiling, routine and stability testing across varieties of biologics products.
- Prepare project proposals, protocols, reports, Certificate of Analysis, investigation reports, and generate cGMP documents.
- Act as Analytical Project Leader, closely interact with clients through various means of communication and ensure high client satisfactions.
- Manage projects from initiation to completion and ensure the projects are on time, on budgets, and meeting pre-established quality standards.
- Train, develop junior staff, and collaborate with cross functional teams including QA, QC, formulation, and small molecules.
- Under strategic direction of BDMS leader, contribute and/or lead the creation of new service portfolios for emerging biotherapeutics.
- PhD in Biological Science, Biochemical Engineering, or related discipline with 4+ year's relevant industrial analytical development experience, or MS with 8+ year's analytical development experience for biologics. Job title to be commensurate with the experiences and qualifications.
- Established track record of success in cell and gene therapy product characterization, cell-based assay, and flow cytometry experience.
- Preference will be given to the candidates with relevant experiences in Lentiviral and AAV vector construction and characterization.
- It is a plus to have experience in applying biochemistry (e.g., icIEF, CE-SDS, HPLC, LC-MS, ELISA, etc.) and biophysics (CD, DSC, DLS, etc.) analytical method for characterization and release of biologics such as recombinant proteins and monoclonal antibodies.
- Experience planning and coordinating analytical projects across multiple stakeholders both internally and externally.
- Experience working in a GMP and GLP environment
- Experience leading teams, managing labs and budgets.
- Prior experiences working in Contract Service industry is a plus.
- Excellent oral and writing communication, and organization skills.