Scientist I/II - Analytical Method Development

Kelly Services; Irvine (CA); On-site; USD 44,000 - 50,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Holiday pay

Job summary

Kelly Services is seeking a Scientist I/II for Analytical Method Development in Irvine, CA, on a 6-month contract. The role involves developing, validating, and transferring analytical methods for drug product development, including formulation and stability testing, with emphasis on cGMP documentation and regulatory readiness.

The candidate will operate HPLC, GC, ICP, UV, FTIR, and other analytical instruments, ensuring quality data and supporting CMC documentation for ANDA filings where

Qualifications

• Bachelor’s Degree (B.S.) or higher in Chemistry, with two or more years of related experience and/or training.
• 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.

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.
• Troubleshoot 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

Skills

Analytical method development

Team collaboration

Technical documentation

English communication

Education

Bachelor’s Degree in Chemistry

Tools

HPLC

GC

Empower

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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .

Kelly Services is proud to be an Equal Employment Opportunity and affirmative action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.