Scientist, Molecular Biology

Position Overview

Critical Performance Areas

Responsibilities

Qualifications

Skills

Benefits

Pay

Schedule

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).

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.

Requirements

• 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.

Desired Skills/Abilities

• 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.
• Bioinformatics experience is desirable, but not a requirement.
• Able to multitask and adjust prioritization as necessary.

Reporting Structure

This Job Typically Reports To Team Lead: Molecular Biology.

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.