Quality & Validation Scientist (Assay Transfer)

Job description

**Assay Transfer, Quality & Validation Scientist (Temporary / Temp-to-Hire)**
**Location:** Gaithersburg, MD (On-site)
**Duration:** 3 months (possible conversion to direct hire depending on 2026 headcount)
**Working Hours:** Monday–Friday, 8:00 AM – 5:00 PM
**Hourly Pay Rate:** **$43–$45/hr**

**Role Overview**
We are seeking **two** driven Assay Transfer, Quality & Validation Scientists to join our QC team.

These roles will support biological and molecular assay development, optimization/robustness, method transfers, qualification/validation, and training of staff.

You will operate with minimal supervision, maintaining assay integrity in a GMP environment and being a subject matter expert for transferred/qualified assays.

**Key Responsibilities**

+ Develop, optimize, transfer, and validate analytical methods (both GMP & Non-GMP), including creating Experimental Protocol Summaries (EPS), executing qualification/validation, and writing and revising SOPs.
+ Design robust qualitative and quantitative assays; determine controls, optimize assays, assess robustness.

Carry out stability studies of critical reagents and standards qualification.
+ Maintain fully compliant records of all assay development, transfer, qualification, validation activities per cGMP.
+ Evaluate and implement new technologies for biological / molecular assays.
+ Act as SME: train analysts on new or transferred assays.
+ Establish and maintain assay trending metrics in alignment with regulatory standards (USP, EP, FDA, ICH).
+ Perform/support QC test methods: nucleic acid extraction, qPCR, restriction digests, agarose gels, sequencing, ELISA, flow cytometry, cell culture.
+ Manage QC materials / lab supplies inventory; monitor, order, record via SAP.
+ Assist in troubleshooting assay issues, supporting investigations (OOS, CAPAs, deviations etc.).
+ Present new reagents/materials to Raw Material Board; manage part numbering and SAP integration.

**Minimum Qualifications**

+ Bachelor’s degree in life sciences (e.g. biology, molecular biology, biochemistry); Master's preferred.
+ Minimum of 5 years’ relevant experience in assay development / validation / transfer; or equivalent combination of education + experience.
+ Strong proficiency in Biological / Molecular assay techniques and methodologies.
+ Understanding of the full analytical method lifecycle: development, qualification, validation, transfer, maintenance.
+ Working knowledge of GMP compliance and Quality Control in a regulated environment.
+ Statistical skills; experience with design of experiments (DOE) and statistical analysis tools (e.g. JMP) preferred.
+ Strong attention to detail, excellent organizational, written & oral communication skills.
+ Familiarity with ICH, EP, USP, FDA regulatory standards as they apply to assays and cell therapy/bio-assay products.

**Why this role may appeal**

+ Hands-on exposure to high-impact molecular and biological assay work in a regulated environment.
+ Opportunity to become a subject matter expert and train others.
+ Potential to convert to direct hire, depending on future departmental needs.

**APPLY NOW FOR IMMEDIATE CONSIDERATION!!**
**#P1**

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources.

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.

Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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

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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 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.

Required Skill Profession

Other General