Associate Analytical Scientist

WuXi AppTec; San Diego (CA); On-site; USD 69,000 - 90,000; Full time

Job summary

STA Pharmaceutical US LLC, a WuXi AppTec Company, is seeking an analytical chemist to join the Analytical Chemistry Department. The role supports routine analytical testing and data verification for process development and manufacturing in cGMP laboratories.

You will perform qualitative and quantitative assays using wet chemistry and state-of-the-art instruments, conduct HPLC and GC method validation and transfers, and maintain instruments while ensuring quality compliance and accurate

Qualifications

• Master's degree in analytical chemistry or a related field is required or BS with 1–2 years of relevant experience.
• Experience in a cGMP environment is preferred.
• Ability to perform qualitative and quantitative analyses using wet chemistry techniques and modern analytical tools.
• Experience with HPLC and GC method validation/transfer is desirable.

Responsibilities

• Support routine analytical testing and data verification for process R&D and production in cGMP laboratories.
• Perform qualitative and quantitative assays following applicable analytical methods.
• Conduct HPLC and GC method validation and transfer activities and prepare related documentation.
• Maintain instruments, troubleshoot issues, and contribute to SOPs and regulatory filings.

Skills

cGMP environment

raw material testing

qualitative & quantitative assays

HPLC

GC

documentation & regulatory filings

problem solving

teamwork

Education

Masters degree in analytical chemistry or related field

BS in analytical chemistry or related field with 1-2 years experience

Tools

HPLC

GC

Regulatory documentation (SOPs/Reports)

Job description

This position reports to the Analytical Chemistry Department at STA Pharmaceutical US LLC. STA Pharmaceutical US LLC, a WuXi AppTec Company, is a contract development and manufacturing organization focused on providing high quality process development, R&D, GLP Tox lots and up to P1/P2 GMP small molecule manufacturing services to the biopharmaceutical industry. The candidate will be responsible for routine analytical testing and data verification supporting both process R&D and Production in cGMP-compliant laboratories and R&D laboratories.

Knowledge / Skills / Abilities

• Work under cGMP environment.
• Perform raw material release, in-process testing, and release testing drug substance as per applicable regulatory and company guidelines.
• Perform qualitative and quantitative assays by following applicable analytical methods using wet chemistry technique and state of the art analytical tool.
• Perform HPLC and GC method validation / method transfer experiments, prepare for method validation protocol, and method validation report, etc.
• Routine instruments maintenance and troubleshooting.
• Authors/co-authors SOP's, protocols, technical reports, specifications and sections for regulatory filings.
• Perform / Assist in analytical method development, stress study, stability indication method development, IPC method development, residual solvent method development, etc.
• Through the scientific reasoning to determine problem, collect information, know the facts, and correct effective conclusions.
• Willing to perform other tasks as required.
• Other duties as assigned.
• Masters degree in analytical chemistry or related field, no work experience required.
• BS in analytical chemistry or related field with 1-2 years of relevant experience.

Requirements

Physical Requirements

• Must be able to wear appropriate PPE
• Must be able to work in environment with variable noise levels
• Ability to stand /Sit/walk for long periods of time
• Ability to identify and distinguish colors
• Must be able to perform activities with repetitive motions

Anticipated Salary Range: $69,036 to $89,570

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.