Senior Scientist - Molecular Biology

https://www.solvias.com/jobs-in-us/senior-scientist-molecular-biology/

Located at our large molecule headquarters in RTP, North Carolina, the Senior Scientist position will be the Subject Matter Expert (SME) for the molecular biology team supporting 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).

Essential Job Functions

• Supervise, participate in lab activities, and act as the subject matter expert (SME) for molecular biology assays.
• Collaborate with the Team Lead to train, develop, and coordinate daily laboratory tasks for the team.
• Develop, validate, and transfer analytical methods for the analysis of drugs using PCR and NGS assays according to GMP requirements.
• Manage multiple projects at the same time and ensure on-time testing and delivery of results to clients.
• Generate and interpret data generated by the team, track assay performance/metrics, troubleshooting assays as needed, and proactively implement performance improvements.
• Communicate effectively across teams, Solvias sites, and with clients, providing scientific expertise to projects.
• Ensure compliance with GMP regulatory requirements and SOPs.
• Review and approve lab notebooks, draft and review protocols, and ensure accuracy of reports.
• Investigate under GMP regulatory guidelines for deviation, non-conformity, OOS, change controls and other quality events.
• Train scientists and analysts in the team as needed and take part in coaching team members to excel scientifically/professionally.
• 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.

• 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 in method development, qualification & validation of qPCR, ddPCR, NGS assays, and emerging technologies.
• Client management experience is highly desirable.

• 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

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 US 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.