Kelly Science, Engineering, Technology & Telecom
Senior QC Microbiologist - Cell & Gene Therapy
Kelly Science, Engineering, Technology & Telecom, Gaithersburg, Maryland, us, 20883
Senior QC Microbiologist – Cell & Gene Therapy
Location:
Gaithersburg, MD (On‑site)
Schedule:
Monday–Friday, 8:00 AM – 5:00 PM (occasional weekends)
Duration:
3 months
Pay Rate:
$47–$50 per hour
Start Date:
ASAP
About The Role We are seeking a
Senior Quality Control Analyst (Microbiology)
to support microbiology programs focused on
lentiviral vector and cell & gene therapy
development. The ideal candidate will have hands‑on experience in a
cGMP microbiology quality control environment , strong technical acumen, and the ability to work independently with minimal supervision. This role plays a key part in ensuring product quality and compliance with internal procedures and regulatory standards (ICH, CFR, etc.).
Key Responsibilities
Execute day‑to‑day microbiology testing and related activities with minimal supervision.
Apply sound scientific and technical judgment to ensure accuracy and reliability of results.
Conduct and write investigations, reports, and deviations independently or with limited assistance.
Identify and support resolution of out‑of‑trend (OOT) and out‑of‑specification (OOS) events.
Contribute to the improvement of existing procedures and development of new laboratory processes.
Coordinate sample shipments, contract laboratory testing, and equipment maintenance.
Maintain and track microbiological data and metrics for management review.
Ensure compliance with all cGMP, internal, and regulatory guidelines.
Required Qualifications
Bachelor’s (B.S.) or Master’s (M.S.) degree in Biotechnology, Biology, Chemistry, or a related field.
5+ years of hands‑on experience in a cGMP microbiology QC laboratory within the biotech or pharmaceutical industry.
Strong understanding of aseptic technique, product sample handling, and microorganism culture.
Proven ability to write and support technical documentation, including SOPs, protocols, and investigations.
Excellent attention to detail, organizational, and problem‑solving skills.
Strong communication abilities—both written and verbal—and experience collaborating with cross‑functional teams.
Proficiency with Microsoft Office applications (Excel, Word, PowerPoint, Outlook).
Preferred Experience
Prior experience supporting cell and gene therapy programs or lentiviral vector manufacturing.
Familiarity with ICH and CFR regulatory guidance.
Demonstrated ability to manage multiple priorities in a fast‑paced, highly regulated environment.
Important Note This role requires
industry experience —candidates with
academic or NIH backgrounds only
will not be considered. Hands‑on biotech or pharmaceutical experience is essential.
Apply Now for Immediate Consideration! 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 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.
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Gaithersburg, MD (On‑site)
Schedule:
Monday–Friday, 8:00 AM – 5:00 PM (occasional weekends)
Duration:
3 months
Pay Rate:
$47–$50 per hour
Start Date:
ASAP
About The Role We are seeking a
Senior Quality Control Analyst (Microbiology)
to support microbiology programs focused on
lentiviral vector and cell & gene therapy
development. The ideal candidate will have hands‑on experience in a
cGMP microbiology quality control environment , strong technical acumen, and the ability to work independently with minimal supervision. This role plays a key part in ensuring product quality and compliance with internal procedures and regulatory standards (ICH, CFR, etc.).
Key Responsibilities
Execute day‑to‑day microbiology testing and related activities with minimal supervision.
Apply sound scientific and technical judgment to ensure accuracy and reliability of results.
Conduct and write investigations, reports, and deviations independently or with limited assistance.
Identify and support resolution of out‑of‑trend (OOT) and out‑of‑specification (OOS) events.
Contribute to the improvement of existing procedures and development of new laboratory processes.
Coordinate sample shipments, contract laboratory testing, and equipment maintenance.
Maintain and track microbiological data and metrics for management review.
Ensure compliance with all cGMP, internal, and regulatory guidelines.
Required Qualifications
Bachelor’s (B.S.) or Master’s (M.S.) degree in Biotechnology, Biology, Chemistry, or a related field.
5+ years of hands‑on experience in a cGMP microbiology QC laboratory within the biotech or pharmaceutical industry.
Strong understanding of aseptic technique, product sample handling, and microorganism culture.
Proven ability to write and support technical documentation, including SOPs, protocols, and investigations.
Excellent attention to detail, organizational, and problem‑solving skills.
Strong communication abilities—both written and verbal—and experience collaborating with cross‑functional teams.
Proficiency with Microsoft Office applications (Excel, Word, PowerPoint, Outlook).
Preferred Experience
Prior experience supporting cell and gene therapy programs or lentiviral vector manufacturing.
Familiarity with ICH and CFR regulatory guidance.
Demonstrated ability to manage multiple priorities in a fast‑paced, highly regulated environment.
Important Note This role requires
industry experience —candidates with
academic or NIH backgrounds only
will not be considered. Hands‑on biotech or pharmaceutical experience is essential.
Apply Now for Immediate Consideration! 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 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.
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