Analyst, Molecular Biology
Solvias, Morrisville, NC, United States
Job Title
Analyst, Molecular Biology
Location
RTP, North Carolina, USA
Overview
We are looking for an experienced analyst in basic laboratory techniques, aseptic handling of reagents and samples, and a general understanding of molecular biology 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 is 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 the 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.
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 regarding project status, issues encountered, and other technical challenges or successes.
Communicate effectively with the MolBio leadership and across various teams at RTP.
Responsibilities
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.
Desired Skills / Abilities
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.
Reporting Structure
Reports to: Team Lead: Molecular Biology
#J-18808-Ljbffr
Analyst, Molecular Biology
Location
RTP, North Carolina, USA
Overview
We are looking for an experienced analyst in basic laboratory techniques, aseptic handling of reagents and samples, and a general understanding of molecular biology 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 is 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 the 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.
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 regarding project status, issues encountered, and other technical challenges or successes.
Communicate effectively with the MolBio leadership and across various teams at RTP.
Responsibilities
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.
Desired Skills / Abilities
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.
Reporting Structure
Reports to: Team Lead: Molecular Biology
#J-18808-Ljbffr