Senior Scientist, Molecular Biology

Position Overview

Located at our large molecule headquarters in RTP, North Carolina, the Senior 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).

Critical Performance Areas

• Supervise, participate in lab activities, and act as the subject matter expert (SME) for molecular biology assays including qPCR, ddPCR, and NGS.
• Coordinate with the Team Lead to train, develop, and coordinate daily laboratory tasks for the team.
• Function as a scientific lead to develop, validate, and transfer analytical methods for the analysis of CGT drug substance/drug products 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.
• Exceed at analyzing/interpreting data and present clearly to senior/junior Solvias team members/clients, track assay performance/metrics, troubleshooting assays as needed, and proactively implement process improvement initiatives.
• Communicate effectively across teams, Solvias sites, and with clients, providing scientific expertise to projects and meeting goals.
• Author and review documents required for onboarding of instrumentation, development/validation projects, raw data from operationalized assays, and daftly navigate the quality management system (QMS) at Solvias.

Responsibilities

Essential Job Functions

• Ensure compliance with GMP regulatory requirements and SOPs. 
• Review and approve data in digital or paper-based lab notebooks, draft & review protocols, validate analysis tools/formulas, and ensure accuracy of internal and external reports.
• Investigate under GMP regulatory guidelines for deviation, non-conformity, OOS, change controls and other quality events. 
• Train scientists and analysts on the team as needed, take part in coaching team members to excel scientifically/professionally, and manage a subset of direct reports.
• Contribute to process improvements for effective and efficient operational workflows in the lab. 
• Oversee inventory maintenance, ordering of laboratory supplies, and instrument maintenance.
• Work collaboratively with cross-functional teams at Solvias and clients on projects/initiatives.
• Able to multitask and adjust prioritization as necessary.

Qualifications

Requirements

• M.S. or Ph.D. Life Sciences with 5+ years relevant experience or 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-facing experience for assay development and operational processing updates is expected.

Other Desired Skills/Abilities

• Excellent organizational skills, constant attention to detail, 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/presenting slide decks for client-facing presentations.
• Lean 6Sigma. 

Reporting Structure

This job typically reports to:

• Team Lead, Molecular Biology

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. A presentation by the candidate is expected if the candidate passes screening stage.

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.