Scientist, Microbiology

Position Overview
Located at our US headquarters in RTP, North Carolina, the Scientist, Microbiology position will be experienced and well versed in various technical aspects related to microbiological testing, microbial identification, culture-based methods, rapid microbiological methods, and environmental monitoring. Experience supporting analytical method development, qualification, validation, and transfer for pharmaceutical, biotechnology, and advanced therapy products is desirable. This position is on-site based in the newly built US headquarters in RTP. The position is part of the Biologics and Novel Modalities laboratory environment and follows Good Manufacturing Practices (GMP).

Please note that this is a fully onsite position and requires regular, in-person attendance at the designated work location. Remote and hybrid work arrangements are not available for this role. The anticipated salary range is up to $100,000 annually, with the final offer determined based on factors such as education, relevant experience, skills, and overall qualifications.

Critical Performance Areas

1. Perform microbiological testing accurately and independently. 
2. Execute assays such as: 
   1. Sterility testing
   2. Bioburden/microbial enumeration
   3. Endotoxin testing
   4. Environmental monitoring
   5. Rapid microbiological methods
3. Coordinate with the Team Lead to execute daily laboratory tasks, such as processing client samples, assay development, and training activities. 
4. Manage multiple tasks at the same time and ensure on-time testing and delivery of the highest quality results to clients.
5. Generate and assess data generated, record assay metrics, and proactively implement performance improvements.
6. Communicate effectively with the Microbiology Team Lead, and across various teams at RTP.

Essential Job Functions

• Ensure compliance with GMP regulatory requirements and SOPs. 
• Process client samples, qualify controls/standards, document all processes in LIMS/ELN, review draft protocols, and other aspects of a laboratory operations regulated environment.
• Participate in investigations of processing deviations, non-conformity, OOS, change controls and other quality events as applicable. 
• Contribute to process improvements for effective and efficient workflows in the lab. 
• Maintain inventory, ordering of laboratory supplies, and instrument maintenance.
• Work collaboratively with cross-functional teams and customers.

Essential Job Functions

• Ensure compliance with GMP regulatory requirements and SOPs. 
• Process client samples, qualify controls/standards, document all processes in LIMS/ELN, review draft protocols, and other aspects of a laboratory operations regulated environment.
• Participate in investigations of processing deviations, non-conformity, OOS, change controls and other quality events as applicable. 
• Contribute to process improvements for effective and efficient workflows in the lab. 
• Maintain inventory, ordering of laboratory supplies, and instrument maintenance.
• Work collaboratively with cross-functional teams and customers.

Requirements

• M.S. or Ph.D. in Microbiology or Life Sciences with 5+ years relevant experience or B.A/B.S. with 10+ years relevant experience. 
• Experience working on rapid sterility, Bioburden, Endotoxin, and monocyte activation technologies in a GMP, GLP, or GCP environment.
• Experience in method development, qualification & validation of microbial methods.

Other Desired Skills/Abilities

• Excellent organizational skills, ability to work independently and collaboratively in a team environment.
• Strong written and verbal communication skills.
• Experience working with LIMS, automation, databases, statistics/programming, and building slide decks for client presentation.
• Lean 6Sigma.
• Able to multitask and adjust prioritization as necessary.
• Bioinformatics experience is desirable, but not a requirement.
• Experience working in a CRO/CDMO highly desired.

Disclaimer: Solvias North America does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting.

NOTE:   This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.