Essential Functions:

• Independently lead the development, qualification, and transfer of analytical methods for purity, content, and other quality attributes of biologic drug substances, carbohydrates, and vaccine targets.
• Develop analytical methods and conduct characterization studies to support raw material, formulation development and the establishment of appropriate manufacturing control strategies.
• Perform analytical method transfer to CROs/CMOs.
• Perform appropriate CRO/CMO oversight by reviewing analytical method development data, reviewing and approving analytical method validation protocols and subsequent reports, and reviewing and approving analytical method SOPs.
• Provide technical oversight to drug substance/drug product release and stability testing, as well as trouble shooting and analytical investigation at CRO/CMOs.
• Author protocols, reports, and regulatory submissions as appropriate.

Requirements:

• PhD in Chemistry, Analytical Chemistry preferred, Organic / Biochemistry considered, with 5+ years relevant industry experience; MS with 8+ or BS with 10+ years of industry experience; (Pharma / Biotech / Analytical Testing) required.
• Ideal candidate will have a strong theoretical understanding and extensive hands-on experience of SEC-MALS technique. Familiar with Wyatt instrument and ASTRA software is a plus.
• Broad hands-on experience with modern analytical instrumentations commonly used in the analysis and characterization of biologics, carbohydrates, conjugates and small molecule drug candidates and successful track record of method development trouble shooting and validation, e.g., UV-Vis, various modes of HPLC, CE, SDS-PAGE, icIEF, LCMS, GCMS, enzyme kinetics, colorimetric and fluorescent plate-based assays, ELISA, Western Blot, etc.
• Self-starter; able and willing to learn new techniques quickly and work in a fast-paced, cross-functional environment and collaborate effectively with other team members.
• Direct experience operating Agilent HPLC using OpenLab/ Chemstation software and/or Waters UPLC and Empower software for data acquisition and analysis.
• Experience working in a regulated (GLP / GMP) environment.
• Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to analytical method development and qualification/validation for small molecules, biologics and vaccines, and demonstrated ability of applying the regulatory guidance to formulate practical solutions and phase appropriate analytical strategy.
• Attention to detail and excellent skills in record keeping / documentation.
• Extensive technical writing experience in drafting method protocols, SOPs and reports.
• Project management skills including the ability to manage one’s project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management.
• Strong interpersonal skills; ability to communicate effectively both verbally and in written formats.
• Constantly identify gaps and areas for improvement and escalate to management as appropriate.