Scientist, Microbiology

Solvias•Morrisville, NC

1d•$100,000•Onsite

About The Position

The Scientist, Microbiology position is located at the US headquarters in RTP, North Carolina. This role requires expertise in various technical aspects of microbiological testing, including microbial identification, culture-based methods, rapid microbiological methods, and environmental monitoring. Experience with analytical method development, qualification, validation, and transfer for pharmaceutical, biotechnology, and advanced therapy products is desirable. This is a fully onsite position in the newly built US headquarters in RTP, part of the Biologics and Novel Modalities laboratory environment, and follows Good Manufacturing Practices (GMP). Remote and hybrid work arrangements are not available. The anticipated salary range is up to $100,000 annually.

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.

Nice To Haves

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.

Responsibilities

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