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Senior Process Development Associate – Analytical
Gaithersburg, MD, US
Scientific
Bachelors Degree
Full Time, Temporary
$40/hr-$50/hr
Experienced (Non-Manager)
On-site
Biotechnology/Pharmaceuticals
First Shift (Day)
Gaithersburg, MD, US
$40/hr-$50/hr
Experienced (Non-Manager)
Full Time, Temporary
Biotechnology/Pharmaceuticals
On-site
Scientific
Bachelors Degree
First Shift (Day)
Job details
Senior Process Development Associate – Analytical
Location: Gaithersburg, MD
Pay Rate: $40–$50/hour
Employment Type: 6-Month Contract (Potential Extension)
Kelly Science & Clinical is seeking a Senior Process Development Associate – Analytical for a contract opportunity with a growing biotechnology organization. This individual will support analytical method and assay development activities for cell and gene therapy programs, with a primary focus on method development, transfer, and qualification. The position will provide hands-on scientific support across multiple client and internal development projects, helping the team meet project timelines and expanding business demands.
Responsibilities
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Support analytical assay and method development, transfer, and qualification activities across multiple development projects.
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Develop, optimize, and evaluate analytical methods to support cell and gene therapy products.
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Perform hands-on analytical testing and assist with ongoing method development projects.
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Support analytical method transfer and qualification activities to ensure methods are suitable for their intended applications.
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Collaborate with Process Development Scientists and other analytical team members to execute project activities and meet timelines.
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Provide analytical testing and project support to other team members as needed to maintain team capacity.
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Document experimental procedures, analytical results, and development activities in accordance with established procedures.
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Contribute to troubleshooting, method optimization, and continuous improvement initiatives.
Qualifications
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Bachelor’s degree in Biology, Biotechnology, Biochemistry, or a related scientific discipline required.
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Typically 3–5 years of relevant industry experience in analytical development, assay development, or a related biotechnology/pharmaceutical environment.
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Hands-on experience with analytical method development, method transfer, and method qualification.
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Experience developing, optimizing, or qualifying potency assays strongly preferred.
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Experience supporting cell and gene therapy, biologics, or viral vector products is highly desirable.
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Familiarity with Design of Experiments (DoE) is beneficial.
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Experience with flow cytometry and/or droplet digital PCR (ddPCR) is a plus.
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Strong laboratory, analytical, troubleshooting, documentation, and collaboration skills.
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