Scientist, Molecular Biology

Job Description

Solvias is an internationally recognized provider of integrated solutions in contract analytical research, development, and manufacturing. The company offers a broad spectrum of services and solutions in the Pharmaceutical, Biotech, Medical Device, Cell & Gene Therapy (CGT), and Cosmetic industries. With headquarters in Switzerland, ~800 highly qualified employees take pride in putting science at the heart of serving customers to bring safer and better products to market faster.

Located at our headquarters in RTP, North Carolina, the Scientist position will be experienced and well versed in various technical molecular biology (MolBio) aspects related to Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) assays. This position is on-site based in the newly built RTP headquarters in North Carolina. The position is part of the Large Molecule & Advanced Therapy Medicinal Products Services laboratory environment and follows Good Manufacturing Practices (GMP).

• Perform PCR & NGS assays with minimal supervision while performing ancillary lab activities to maintain optimal laboratory function/performance.
• Coordinate with the Sr. Scientist &/or Team Lead to execute daily laboratory tasks, such as processing client samples, assay development, and training activities.
• Assist in the development, validation, and transfer of analytical methods for the analysis of cell & gene therapy drug products using PCR and NGS assays according to GMP requirements.
• 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 generated, record assay metrics, and proactively implement performance improvements.
• Communicate effectively with the MolBio Sr. Scientist, MolBio 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.

Requirements

• M.S. or Ph.D. Life Sciences with 5+ years relevant experience or B.A/B.S. with 10+ 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 qualification/validation of qPCR, ddPCR, NGS assays, and other emerging technologies.

Other Desired Skills/Abilities

• 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.

Reporting Structure
This job typically reports to:

• Team Lead: Molecular Biology & Virology

Note: This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.

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.

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