Scientist I, CMC Analytical Development

Tandym Group; California; On-site; USD 80,000 - 120,000; Full time

Job summary

A leading biopharma company in the Bay Area is seeking a Scientist to join their Technical Development Department. The role involves developing analytical methods, supporting characterization studies, and collaborating with various functions to ensure lab safety and effective project execution.

Qualifications

• 2+ years experience with a Ph.D; or 4+ years with a Master's; or 6+ years with a Bachelor's.
• Experience with state-of-the-art analytical technologies for biologics.

Responsibilities

• Develop analytical methods and support characterization studies for biologics.
• Author and review protocols, technical reports, and method SOP.

Skills

Analytical Methods

Communication

Education

Ph.D.

Master's Degree

Bachelor's Degree

Tools

HPLC

CE

LC-MS

Job description

A biopharma company in the Bay Area is actively seeking a new Scientist to join their growing Technical Development Department. In this role, the Scientist will be responsible for developing physicochemical analytical methods (HPLC, CE, LC / MS), performing extensive characterization on both early and late-stage molecules for orphan diseases, and supporting process and formulation development through routine testing.

Responsibilities :

• Develop analytical methods, support extended characterization studies for biologics-based therapeutics
• Support process and formulation development by providing analytical testing results
• Author and review protocols, technical reports, and method SOP
• Contribute to laboratory and manufacturing investigations, develop and execute experiments in the laboratory as needed
• Collaborate effectively with other functions, including process development, manufacturing, quality control, quality assurance, regulatory affairs, etc.
• Maintain lab safety, equipment, and reagents

Qualifications :

• Previous experience as a Scientist (2+ years of experience with a Ph.D; or , 4+ years of experience with a Master's Degree; or , 6+ years of experience with a Bachelor's Degree)
• Experience with HPLC / UPLC's, CE and iCIEF analytical methods and instrumentation
• Experience of state-of-the-art analytical technologies for biologics, such as HPLC (various modes and detections), CE-SDS, icIEF, LC-MS, peptide map, glycan map, disulfide map, DSC, FT-IR, CD, fluorescence spectroscopy, particle analysis
• Excellent written and verbal communication skills
• Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates
• Ability to engage collaboratively with CMC functions and external testing laboratories

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