Our client is looking for an energetic, self-motivated, and talented individual to join our CMC team. The candidate must have proven record of analytical development and characterization, and hands on experience in using Capillary Electrophoresis and various analytical techniques to develop analytical methods for proteins, conjugates, and polysaccharides when applicable. The candidate will independently develop analytical methods (including but not limited to: CE, different modes of chromatography, LCMS, colorimetric and light-scattering technique) for GMP quality control and characterization purposes. Additional responsibility will also include analytical data review, authorship of method SOPs, study protocols and reports, technical support for assay transfer between our company and external CMO partner groups. The person will also serve as SME to provide technical support for troubleshooting effort in the CMOs.
Essential Functions:
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- Independently propose, develop, and transfer analytical methods for release, stability, in-process monitoring, and characterization and quality control of proteins, and protein-polysaccharide conjugates, to support process development/characterization and the establishment of appropriate manufacturing control strategies.
- The job responsibility may also include identifying suitable CRO or research institute partners to co-develop analytical methods. Develop project plans and analytical technical roadmap with identified external partners. Provide appropriate oversight of project conducted externally by critically reviewing analytical development data, providing necessary guidance, and troubleshooting solutions to move project forward, reviewing and approving analytical development reports and analytical method SOPs.
- Author method SOP, study protocols, reports, and CMC sections of regulatory submissions as appropriate.
- Provide troubleshooting support to CMO and internal QC.
- Partner with process development scientists, CMC functional heads and project management to deliver the project milestones.
Requirements:
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- PhD in Chemistry, Analytical Chemistry preferred, with 3+ years relevant industry experience; MS or BS with 8+ years of industry experience; (Pharma / Biotech / Analytical Testing) required.
- Extensive hands-on experience in using CE, IEF, and various CE technology, as well as other separation techniques such as HPLC to quantitate and characterize proteins and their conjugates is a must.
- In depth knowledge on capillary electrophoresis in general and solid understanding of theory, operating principles, and advantages/disadvantage of various CE instrument platforms as well as familiarity with associated data acquisition and data analysis software.
- Experience in employing DOE methodologies for analytical method development and familiarity with SAS JMP other data analysis software.
- Ideal candidate will have a strong theoretical understanding of various analytical chemistry methodology principles and successful track record of end-to-end delivery to meet the analytical challenges, from analytical technology selection and method development to transfer and validation.
- Extensive hands-on experience with modern analytical instrumentations commonly used in the analysis and characterization of biologics, carbohydrates, conjugates, and small molecule drug candidates.
- 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 and demonstrated ability of applying the regulatory guidance to formulate practical solutions and phase appropriate analytical strategy.
- Solid understanding of product development activities in biotech/drug/vaccine development, including key interdependencies, and knowledge of proven development strategies and tactics.
- Self-starter with ability to map out project milestones, apply sound judgment, excellent project management and problem-solving skills to delivered desired outcomes within timelines.
- Strong planning and tracking skills, well-organized, results oriented, capable of managing multiple projects with respect to priorities and resource.
- Adaptable fast learner with excellent skills for integrating and interpreting interdisciplinary connections.
- Able to work in a fast-paced, cross-functional environment and collaborate effectively with other team members.
- Extensive technical writing experience in drafting method protocols, SOPs, and reports.
- Strong interpersonal skills; ability to communicate effectively both verbally and in written formats.
- Attention to detail and excellent skills in record keeping / documentation.
- All employees require vaccination against COVID-19.