Research Associate (cell based assays)

Job description:

Quality Control Chemist

Job Type: Contract – 6 Months

Location: Frederick, MD

Work Arrangement: 100% Onsite

Schedule: Wednesday–Saturday, 3:00 PM–1:30 AM EST

Training Schedule: Monday–Friday, 7:30 AM–4:00 PM EST for the first 7 weeks

Job Overview

We are seeking a detail-oriented Quality Control Chemist to support laboratory testing and quality control activities in a biotechnology or pharmaceutical manufacturing environment. The ideal candidate will have knowledge of GMP regulations, analytical testing methods, laboratory documentation, and quality systems.

The selected candidate will perform testing of raw materials, intermediates, drug substances, and final products while ensuring compliance with established procedures and regulatory requirements.

Key Responsibilities

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• Perform analytical testing of raw materials, intermediates, drug substances, and final products using cell-based bioassays, flow cytometry, ELISA, and qPCR.
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• Maintain laboratory equipment and instruments through routine maintenance and calibration.
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• Review and trend laboratory data, test results, and supporting documentation for in-process testing and product release.
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• Support the preparation of Certificates of Analysis (CoAs) for product release.
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• Author, revise, and maintain Standard Operating Procedures (SOPs), qualification protocols, validation protocols, and reports.
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• Assist with out-of-specification (OOS) investigations, deviations, root cause analysis, and corrective actions.
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• Ensure laboratory activities comply with GMP requirements, documented procedures, and applicable quality standards.
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• Review proposed changes to laboratory systems, procedures, analytical methods, and regulatory submissions as appropriate.
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• Collaborate with internal teams and external resources to maintain laboratory readiness and operational efficiency.
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• Provide updates during daily and weekly meetings.
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• Collect and analyze metrics to support continuous improvement initiatives.
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• Perform additional duties as required.
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Basic Qualifications

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• Bachelor's degree in a relevant scientific field; OR
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• Associate degree with at least 2 years of experience in biotechnology or a related field, including Quality Control experience; OR
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• High school diploma or equivalent with at least 3 years of experience in biotechnology or a related field, including Quality Control experience.
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Preferred Qualifications

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• Experience in the biotechnology or pharmaceutical industry.
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• Strong knowledge of GMP, SOPs, and laboratory quality control processes.
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• Experience identifying, documenting, investigating, and closing OOS results and laboratory investigations.
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• Hands-on experience with flow cytometry, ELISA, PCR/qPCR, cell-based bioassays, or other analytical methods used for biopharmaceutical testing.
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• Working knowledge of quality systems and regulatory requirements, including 21 CFR Parts 11, 210, and 211.
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• Proficiency in Microsoft Word, Excel, PowerPoint, and related applications.
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• Strong written and verbal communication skills.
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• Ability to work independently and collaborate effectively with scientific and technical teams.
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Important Schedule Requirements

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• This is a 6-month contract position requiring 100% onsite work in Frederick, MD.
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• During the first 7 weeks, contractors must work Monday–Friday, 7:30 AM–4:00 PM EST, to complete new-hire orientation and manufacturing onboarding technical training.
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• After the initial training period, contractors will transition to the agreed-upon Wednesday–Saturday shift, 3:00 PM–1:30 AM EST.
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• Candidates must be comfortable with the initial training schedule and the subsequent evening shift.
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Interested candidates: Please submit your updated resume highlighting relevant Quality Control laboratory experience, analytical testing techniques, and GMP compliance knowledge.