Scientist I/II - Analytical Method Development

Vita Global Sciences, a Kelly Company; Irvine (CA); On-site; USD 44,000 - 50,000; Full time

Job summary

Vita Global Sciences, a Kelly Company, in Irvine, CA, seeks a Scientist I/II to advance analytical method development for drug product programs. The role is a 6-month contract with a rate of $32–$36 per hour (DOE) and a daytime shift.

Responsibilities include development, validation, transfer of USP methods, and method troubleshooting across HPLC/GC/ICP/UV platforms. Strong documentation and cGMP compliance are essential.

Qualifications

• Bachelor's degree in Chemistry with 2+ years of related experience.
• Pharmaceutical setting experience with small molecules and good documentation practice (cGMP).
• Hands-on experience with HPLC/GC for assay, impurity, solvents, and dissolution; Empower software.

Responsibilities

• Support analytical method development, validation, and transfer for drug product development.
• Validate/verify USP methods; write review protocols, reports, SOPs.
• Conduct method improvements and troubleshooting for analytes and materials.
• Ensure good documentation practices in notebooks, logs, and reports.
• Conduct method development and feasibility studies for assay and related characteristics.

Skills

cGMP knowledge

Analytical method development

Documentation

Team communication

Education

Bachelor's Degree in Chemistry

Tools

HPLC

GC

Empower

UV

ICP

Job description

Job Title: Scientist I/II - Analytical Method Development

Location: Irvine, CA

Contract Duration: 6 months

Rate: $32-36/hr. (DOE)

- DAY SHIFT -

PRIMARY DUTIES AND RESPONSIBILITIES:

• Support analytical method development, validation, and transfer for drug product development including formulation development, stability tests, and release tests.
• Validate/verify new or existing USP methods, write and review method validation/verification protocols, reports, analytical method, and SOPs.
• Conduct method improvements and modifications on commercial or new product analytical methods for drug substance and product for continued improvements.
• Trouble-shoot problems of instrument or analytical methods for raw materials, finished product.
• Good documentation practice for lab notebook, logbook, validation and verification report, stability studies, lot release testing, and protocol driven R&D studies.
• Conduct method development and USP method feasibility studies for assay, trace minerals, and associated characteristics for drug products

ASSOCIATED DUTIES AND RESPONSIBILITIES:

• Operate HPLC, GC, ICP, UV, FTIR, dissolution, Malvern Particle Analysis, XRD, and other analytical instrumentation.
• Analyze organic and inorganic compounds to determine chemical and physical properties.
• Method development, validation or verification, and method transfer.
• Other related duties as assigned by lab Director.

REQUIRED SKILLS, ABILITIES, AND QUALIFICATIONS:

• Bachelor’s Degree (B.S.) or higher in Chemistry, with two or more years of related experience and/or training; or equivalent combination of education and experience.
• Worked in a Pharmaceutical company (4 years or more) on small molecules with good documentation practice/cGMP.
• Developed and validated analytical methods using HPLC, or GC, for assay, impurity, residual solvents, and dissolution. Hands on experience using Empower software.
• Experience in supporting CMC documents for ANDA filing is preferred.
• Work well in a team environment with good communication both verbal and written English language for clear and accurate documentation of results and communicate for project update.
• Mastery in calculations with good lab records for lab notebooks, logbooks, and laboratory reports according to good documentation practice for cGMP compliance.
• Ability to understand cGMP principles and FDA regulations for drug product development.
• A self-starter, working under limited supervision, and capable of taking initiative in prioritization and implementation of work.
• Ability to read and interpret scientific articles and documents, such as method development publications, FDA regulations, safety rules, and procedure manuals.
• Ability to apply mathematical operations to tasks as determination of test reliability and validity, analysis of variance or RSD, correlation coefficient with linear regression, as well as difference (f1) and similarity factor (f2).
• Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form.
• Experience with FDA audit for cGMP compliance is desirable.