RA​/SRA, Analytical Chemistry and QC

Job Title

RA/SRA, Analytical Chemistry and QC

36984

San Diego County, CA

Responsibilities

• Conduct routine/non-routine analysis of in-process, toxicology, finished drug substance and drug product samples (i.e. release and stability testing)
• Manage new and ongoing development projects
• Review analytical data for compliance to SOPs (e.g. Analytical Methods, Equipment Procedures, Material Specifications)
• Present and participate in internal and external scientific meetings
• Assemble and document data for quality review
• Revise SOPs as needed (e.g. Analytical Methods, Equipment Procedures, Material Specifications)
• Author and execute qualification/validation protocols and write reports
• Author scientific reports and portions of Chemistry, Manufacturing, and Controls (CMC) section of regulatory filings
• Conduct analytical investigations
• May develop and/or optimize analytical methods
• Applies knowledge of cGMP and GLP on a daily basis

• BS/MS degree in Chemistry or related field
• At least 4 years (Research Associate II) or 7+ years (Sr. Research Associate) experience in an analytical development and quality control role
• Practical knowledge of HPLC, MS, and GC
• Knowledge and previous applications of cGMPs preferable
• Experience following SOPs (i.e. Analytical Methods, Equipment Procedures, Material Specifications)
• Ability to be the technical leader of a scientific project
• Ability to interpret experimental results and correctly identify a path forward independently
• Strong organizational skills
• Experience recording data in laboratory notebooks or data collection forms
• Comfortable with the operation and troubleshooting of instrumentation (lab equipment)
• Communicate effectively, both verbally and in written form, to all levels of the organization
• Ability to carry through on assignments, meet deadlines and time schedules
• Ability to be flexible with workload and job duties to support team objectives
• Experience managing development projects
• Will build positive teamwork, encourage solutions, and solicit feedback to problems and demonstrate respectful behavior to others
• Be an active listener; provide open, constructive feedback to suggestions or opinions presented

• BS/MS degree in Chemistry or related field
• At least 4 years (Research Associate II) or 7+ years (Sr. Research Associate) experience in an analytical development and quality control role
• Practical knowledge of HPLC, MS, and GC
• Knowledge and previous applications of cGMPs preferable
• Experience following SOPs (i.e. Analytical Methods, Equipment Procedures, Material Specifications)
• Ability to be the technical leader of a scientific project
• Ability to interpret experimental results and correctly identify a path forward independently
• Strong organizational skills
• Experience recording data in laboratory notebooks or data collection forms
• Comfortable with the operation and troubleshooting of instrumentation (lab equipment)
• Communicate effectively, both verbally and in written form, to all levels of the organization
• Ability to carry through on assignments, meet deadlines and time schedules
• Ability to be flexible with workload and job duties to support team objectives
• Experience managing development projects
• Will build positive teamwork, encourage solutions, and solicit feedback to problems and demonstrate respectful behavior to others
• Be an active listener; provide open, constructive feedback to suggestions or opinions presented

Salary: $70-100K
HPLC and GC knowledge and expertise required
Experience in a regulated (GMP/GLP) environment is required
This is an onsite laboratory role in North County San Diego