Associate Analytical Scientist

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

Job summary

STA Pharmaceutical US LLC is seeking an Analytical Chemistry professional to support process R&D and cGMP operations in US laboratories. The role includes routine analytical testing, data verification, and collaboration with R&D and production teams.

Responsibilities include performing HPLC/GC analyses, method validation support, instrument maintenance, SOP writing, and ensuring safety and quality standards in a fast-paced environment.

Qualifications

• Master's degree in analytical chemistry or related field.
• BS in analytical chemistry or related field with 1–2 years of relevant experience.

Responsibilities

• Work under cGMP environment.
• Perform raw material release, in-process testing, and release testing of drug substance per guidelines.
• Perform qualitative and quantitative assays using wet chemistry and analytical tools.
• HPLC and GC method validation / transfer, prepare validation protocol and report.
• Routine instrument maintenance and troubleshooting.
• Authors SOPs, protocols, technical reports for regulatory filings.
• Assist in method development, stress/stability and IPC studies.
• Demonstrate scientific reasoning to identify issues and conclusions.

Skills

Analytical chemistry knowledge

Attention to detail

Data integrity

Teamwork

MS Office proficiency

Education

Master's degree in analytical chemistry

BS in analytical chemistry

Tools

HPLC

GC

LC-MS

Dissolution

GC-MS

Job description

Overview

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.

Responsibilities

• 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.

Qualifications

• 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.

Knowledge / Skills / Abilities:

• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
• Meticulous, detail oriented, punctual and willing to switch shift as needed.
• Able to use excel, power point, other MS Office applications and standard statistical analysis tools.
• Experience with variety of analytical techniques, method development and validation.
• Hands‑on experience in HPLC, GC, LCMS, Dissolution and GCMS is a plus.
• Excellent communication (oral and written) and attention to detail.
• Experience with high pressure chromatography systems and software required.
• Experience with capillary electrophoresis preferred.
• Strong organizational and communication skills are required.
• Experience with electronic notebook programs preferred.
• Understand and adhere to safety, quality and cGMP standards.
• Ability to work in a team environment and independently as required.
• Maybe required to work Holidays and weekends.
• Maybe required to work overtime

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.