Senior Scientist, Molecular Biology

Solvias•Morrisville, NC

2d•$118,000•Onsite

About The Position

The Senior Scientist, Molecular Biology is an onsite role at Solvias’s large molecule headquarters in RTP, North Carolina, within a Good Manufacturing Practices (GMP) laboratory environment focused on Large Molecule and Advanced Therapy Medicinal Products Services. The role serves as a scientific lead and subject matter expert for molecular biology assays, including qPCR, ddPCR, and next-generation sequencing (NGS), supporting analysis of cell and gene therapy (CGT) drug substances and drug products. The position supervises and participates in laboratory activities, coordinates daily work and training with the Team Lead, and develops, validates, qualifies, and transfers analytical methods. It manages multiple projects and client deliverables, interprets and presents data, monitors assay performance, troubleshoots assays, and contributes to process improvements. The role also authors and reviews scientific and quality documentation, supports compliance with GMP requirements and standard operating procedures, investigates quality events, and manages a subset of direct reports. This position is fully onsite; remote and hybrid arrangements are not available. The anticipated salary is up to $118,000 annually, with the final offer based on education, relevant experience, skills, and qualifications. The role typically reports to the Team Lead, Molecular Biology. A candidate presentation is expected after the screening stage. Solvias North America does not offer relocation packages or sponsor work visas; applicants must have legal authorization to work at the job location.

Requirements

M.S. or Ph.D. in Life Sciences with at least 5 years of relevant experience, or a B.S. with at least 10 years of relevant experience.
Experience with NGS, qPCR, ddPCR, genomic library preparation, and nucleotide extraction in a GMP, GLP, or GCP environment.
Experience in method development, qualification, and validation for qPCR, ddPCR, NGS assays, and emerging technologies.
Client-facing experience supporting assay development and operational processing updates.
Excellent organizational skills, consistent attention to detail, and ability to work independently and collaboratively.
Strong written and verbal communication skills.
Legal right to work at the job location; the employer does not sponsor work visas.

Nice To Haves

Experience with LIMS, automation, databases, statistics or programming.
Experience building and presenting slide decks for client-facing presentations.
Lean Six Sigma experience.

Responsibilities

Supervise and participate in laboratory activities and act as the subject matter expert for qPCR, ddPCR, and NGS assays.
Coordinate with the Team Lead to train, develop, and assign daily laboratory tasks for the team.
Lead development, validation, and transfer of analytical methods for CGT drug substances and drug products using PCR and NGS assays in accordance with GMP requirements.
Manage multiple projects and ensure testing and client results are delivered on time.
Analyze and interpret data; present results clearly to Solvias colleagues and clients; track assay performance and metrics; troubleshoot assays; and implement process improvements.
Communicate across teams and Solvias sites and with clients, providing scientific expertise to projects and supporting achievement of goals.
Author and review documentation for instrumentation onboarding, development and validation projects, and raw data from operationalized assays; navigate the Solvias quality management system.
Ensure compliance with GMP regulatory requirements and SOPs.
Review and approve data in digital or paper-based laboratory notebooks; draft and review protocols; validate analysis tools and formulas; and ensure internal and external reports are accurate.
Investigate deviations, non-conformities, out-of-specification results, change controls, and other quality events under GMP regulatory guidelines.
Train scientists and analysts, coach team members in scientific and professional development, and manage a subset of direct reports.
Contribute to effective and efficient laboratory workflows through process improvements.
Oversee inventory maintenance, laboratory supply ordering, and instrument maintenance.
Collaborate with cross-functional Solvias teams and clients on projects and initiatives.
Multitask and adjust priorities as needed.