Senior QC Microbiologist – Impactful Pharma Testing

Kindeva Drug Delivery; Lexington (KY); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Purpose-driven work

Growth potential

Collaborative team

Direct impact on patient care

Industry-leading innovation

Job summary

Kindeva Drug Delivery in Lexington, KY, seeks a Senior QC Microbiologist I to join the Quality Control Microbiology team. You will lead hands-on testing, develop and qualify microbiological methods for raw materials, in-process materials, and finished products, and ensure cGMP compliance and inspection readiness.

You will perform routine testing, support investigations and CAPA, and provide technical guidance to junior staff while maintaining strict adherence to USP/ICH standards and regulatory

Qualifications

• BA/BS degree in Biology, Microbiology, Life Sciences, or related field.
• Experience in a cGMP laboratory environment (5+ years).
• Proficiency with Microsoft Office (Word, Excel, Outlook).
• Good verbal and written communication skills.
• Qualified to work with controlled substances.

Responsibilities

• Develop, qualify, and improve microbiological methods for raw materials, components, in‑process materials, and finished product testing in alignment with GMP, USP, and ICH standards.
• Perform release and/or stability testing on excipients, components, drug substances, and drug products.
• Execute and troubleshoot compendial microbiological testing (USP) and related methods.
• Support environmental monitoring, trending, and report creation.
• Author and revise SOPs, test methods, and laboratory documentation; support audits and regulatory readiness.

Skills

MS Office

Communication skills

Controlled substances handling

Education

BA/BS in Biology or Microbiology or Life Sciences

Job description

Kindeva Drug Delivery in Lexington, KY, seeks a Senior QC Microbiologist I to join the Quality Control Microbiology team. You will lead hands-on testing, develop and qualify microbiological methods for raw materials, in-process materials, and finished products, and ensure cGMP compliance and inspection readiness.

You will perform routine testing, support investigations and CAPA, and provide technical guidance to junior staff while maintaining strict adherence to USP/ICH standards and regulatory