What are the responsibilities and job description for the Scientist, Molecular Biology position at Solvias?
Position Overview
JOB DESCRIPTION
Located at our large molecule headquarters in RTP, North Carolina, the Scientist, Molecular Biology will be experienced and well versed in various molecular biology (MolBio) techniques related to Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) assays. This position is on-site based and is part of the Large Molecule & Advanced Therapy Medicinal Products Services laboratory environment following Good Manufacturing Practices (GMP).
Critical Performance Areas
Essential Job Functions
QUALIFICATIONS
This Job Typically Reports To
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.
About Us
Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the life sciences industry. Our expert team combines decades of experience with regulatory expertise across small molecules, biologics, and cell and gene therapies. Solvias offers end-to-end solutions from raw material testing to drug product release and API development for small molecules. Headquartered near Basel, Switzerland, Solvias operates six global Centers of Excellence, all adhering to the highest ISO, GMP, GLP, and FDA standards
JOB DESCRIPTION
Located at our large molecule headquarters in RTP, North Carolina, the Scientist, Molecular Biology will be experienced and well versed in various molecular biology (MolBio) techniques related to Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) assays. This position is on-site based and is part of the Large Molecule & Advanced Therapy Medicinal Products Services laboratory environment following Good Manufacturing Practices (GMP).
Critical Performance Areas
- Consistently & reliably document client and control samples through nucleic acid isolation, PCR, & NGS assays with minimal supervision. In addition to performing above, conduct quality lab activities to maintain optimal laboratory function/performance in a highly regulated environment.
- Coordinate with the Senior Scientist &/or Team Lead to execute daily laboratory tasks, such as processing client samples, assay development project design and testing, as well as training activities.
- Assist in the development, validation, and transfer of analytical methods for the analysis of cell & gene therapy products according to GMP requirements. Perform routine testing of client samples across various phase appropriate validated GMP assays.
- Manage multiple tasks at the same time and ensure on-time testing and delivery of the highest quality results.
- Generate data, record assay metrics, provide troubleshooting support, and proactively implement performance improvements.
- Communicate effectively with the MolBio leadership, 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 Laboratory Information Management Systems/Electronic Lab Notebooks (LIMS/ELN), review draft protocols, and other aspects of a laboratory operations regulated environment.
- Participate in investigations of processing Quality Events (QE): deviations, non-conformity, OOS, change controls, and other QEs as they occur.
- Train peers and analysts in the team as needed.
- Contribute to process improvements for effective and efficient workflows in the lab.
- Maintain inventory, order laboratory supplies, organize instrument maintenance, etc.
- Work collaboratively with cross-functional teams and with clients.
QUALIFICATIONS
- Ph.D. Life Sciences with 3 years, M.S. with 5 years, or B.A/B.S. with 7 years relevant experience.
- Experience working on NGS, qPCR, ddPCR, genomic library preparation, and nucleotide extraction in a GMP, GLP, or GCP environment.
- Experience working in a regulated operational & development environment involved in validation of qPCR, ddPCR, NGS assays, and other emerging technologies.
- Previous CRO experience.
- Excellent organizational skills along with the ability to work both independently and collaboratively in a team environment.
- Strong written and verbal communication skills.
- Experience working with spreadsheets, LIMS, ELNs, laboratory automation, databases, statistics/programming, and building slide decks for client presentation.
- Lean 6Sigma training.
- Able to multitask and adjust prioritization as necessary.
- Bioinformatics experience is desirable, but not a requirement.
This Job Typically Reports To
- Team Lead: Molecular Biology.
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.
About Us
Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the life sciences industry. Our expert team combines decades of experience with regulatory expertise across small molecules, biologics, and cell and gene therapies. Solvias offers end-to-end solutions from raw material testing to drug product release and API development for small molecules. Headquartered near Basel, Switzerland, Solvias operates six global Centers of Excellence, all adhering to the highest ISO, GMP, GLP, and FDA standards