Samsung Biologics is looking for a QC Microbiologist who will be responsible for performing microbiological testing in support of GMP manufacturing operations, ensuring compliance with regulatory requirements and company quality standards. This role supports environmental monitoring, utilities testing, and raw material or in-process sample analysis to ensure product safety and quality. Based at our Rockville, Maryland site, the QC Microbiologist works cross-functionally with Manufacturing, QA, and Facilities to maintain a state of control within the production environment and support timely batch release.
Key Responsibilities- Lead and supervise QC Microbiology laboratory staff, including scheduling work assignments, reviewing analytical data and documentation, and managing performance and development of direct reports.
- Foster a culture of compliance with Safety, Environmental, and cGMP requirements while promoting a Right-First-Time and continuous improvement mindset.
- Drive team performance through effective communication, coaching, and adherence to site policies and procedures.
- Oversee laboratory operations, including inventory management, productivity improvements, corrective action tracking, and execution of special projects.
- Ensure proper training and qualification of personnel to maintain compliance with departmental and regulatory standards.
- Perform and oversee laboratory testing, including material qualification, method validation/transfer, and product testing, ensuring accuracy and timeliness.
- Review and approve technical documents, analytical protocols, and reports generated within the QC Microbiology laboratory.
Scope of Role- This role involves a combination of office and laboratory work, including handling potentially hazardous chemical reagents (e.g., corrosive, toxic, flammable materials), operating analytical equipment, and participating in meetings. Physical activities include sitting, standing, walking, and occasional bending or lifting of small containers or equipment.
- The position also requires periodic work outside standard hours to support on-call responsibilities such as chamber management, product testing, and data review.
Qualification Requirements- Bachelor's or Master's degree in Biology, Microbiology, Virology, Biochemistry, or a related field, with a minimum of 5 years of relevant experience in laboratory, manufacturing, or quality control/assurance environments.
- Experience working in a GMP-regulated environment.
- Strong written and verbal communication skills.
- Technical expertise in microbiology or related biological sciences.
The anticipated salary range for this position in Maryland is $102,000 to $136,000 plus annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc.
Benefits:• 13 paid holidays
• Vacation time
• 401K match
• Medical, dental and vision benefits effective day one of employment
