What are the responsibilities and job description for the Analyst, Molecular Biology position at Solvias?
Position Overview
JOB DESCRIPTION
Located at our large molecule headquarters in RTP, North Carolina, the Analyst, Molecular Biology will be experienced in basic laboratory techniques, aseptic handling of reagents and samples, and is required to have a general understanding of molecular biology (MolBio) processes, such as, but not limited to, Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS). This position is on-site based at the newly built North America Center of Excellence in RTP, North Carolina and part of the Large Molecule & Advanced Therapy Medicinal Products Services laboratory adhering to Good Manufacturing Practices (GMP) standards.
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 Analyst, Molecular Biology will be experienced in basic laboratory techniques, aseptic handling of reagents and samples, and is required to have a general understanding of molecular biology (MolBio) processes, such as, but not limited to, Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS). This position is on-site based at the newly built North America Center of Excellence in RTP, North Carolina and part of the Large Molecule & Advanced Therapy Medicinal Products Services laboratory adhering to Good Manufacturing Practices (GMP) standards.
Critical Performance Areas
- Perform quality lab activities according to assigned schedule.
- Process samples for release and stability testing of drug product/drug substances as part of the Operations routine testing team, including complex sample preparation and in compliance with GMP requirements.
- Document experiments, sample tracking, and raw data according to Standard Operating Procedures (SOPs) and GMP standards.
- Support development and validation of PCR & NGS assays.
- Generate raw data, perform data analysis, and interpret data for assays as needed.
- 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.
- Generate data, record assay metrics, and proactively implement performance improvements.
- Communicate effectively with the MolBio leadership with regard to project status, issues encountered, and/or other technical challenges/successes.
- 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.
- 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.
QUALIFICATIONS
- M.S. with 2 years, or B.A/B.S. with 3 years relevant experience.
- Experience working on at least 2-3 of the following: NGS, qPCR, ddPCR, genomic library preparation, and nucleotide extraction in a GMP, GLP, or GCP environment.
- Experience working in a regulated MolBio operational laboratory environment and adhering to strict GMP/GDP/GLP/GCP standards.
- Excellent organizational skills along with the ability to work independently and collaboratively in a team environment.
- Strong written and verbal communication skills.
- Experience working with LIMS, laboratory automation, databases, and statistics/programming.
- 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