Senior Scientist in Inhalations performing complex laboratory testing, method development, validation, and mentorship within a GMP analytical laboratory.
Responsibilities
Independently performs complex laboratory testing
Communicates analytical needs and resources
Maintains strong hands‑on laboratory presence
Assists with testing execution, troubleshooting, and optimization
Applies advanced scientific judgment
Requirements
Bachelor's degree in chemistry, analytical chemistry, pharmaceutical science or related field
The role involves independently performing complex laboratory testing and providing hands-on technical coaching and mentorship within the laboratory, specifically focusing on Mass Spec/Extractable and Leachables.
Responsibilities
Independently performs complex laboratory testing, including challenging routine testing, analytical investigation support, development, transfer, or validation activities.
Communicates analytical needs, resources, and/or barriers with relevant stakeholders.
Maintains a strong hands-on laboratory presence and serves as a technical resource during test execution.
Actively assists with testing execution, troubleshooting, and optimization rather than directing work from outside the lab.
Applies advanced scientific judgment to execution strategy, data interpretation, and problem resolution.
Requirements
Bachelor's degree in a relevant area, ie. chemistry, biochemistry
The Staff Scientist provides expert-level technical leadership within the laboratory as a senior scientific contributor and recognized technical authority. This role delivers oversight for nonroutine programs (analytical development, validation, transfer) and/or serves as a subject matter expert (SME) for specific analytical technologies, while maintaining an active laboratory presence.
Responsibilities
Provides technical oversight for complex, non-routine analytical testing (analytical development, validation, and transfer), method establishment, and technology-driven programs.
Serves as a senior technical authority and SME for one or more analytical technologies, platforms, or scientific disciplines.
Guides scientific decision-making to ensure appropriate experimental design, execution strategy, and data interpretation.
Reviews and/or approves technical documents including methods, protocols, reports, and quality records to ensure quality and compliance.
Senior Scientist responsible for method validations, transfers, and verifications on APIs and finished products, applying GMP and leading analytical investigations.
Responsibilities
Perform method validations, transfers, and verifications on APIs and finished products
Apply GMP principles in all responsibilities
Conduct analytical investigations using HPLC, GC, UV/Vis, and dissolution techniques
Troubleshoot instrumentation and coordinate with vendors
Train and mentor junior staff in laboratory procedures
Support the Chemistry lab start‑up and perform qualification and routine testing at the Holly Springs Facility, including writing procedures, executing system qualification, method transfers, and managing quality documentation.
Compensation
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
Responsibilities
Support the startup of the QC organization by leading QC Chemistry start‑up activities including system qualification and validation and method transfers
Work collaboratively with site teams to establish work order and PM system for laboratory equipment
Assist with review of validation documents to support equipment and computerized system onboarding
Assist with creating and collaborating on Data Integrity Assessments for computerized lab systems
Author, revise and review documents and reports including SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, technical reports, method assessments, and technical assessments
Requirements
High school/GED
Associate's degree
Bachelor's degree
Master's degree
Nice to have: Degree in Chemistry, Biochemistry, Physics or Chemical Engineering
Lead and support analytical method transfers for large molecule bioassays, ensuring robustness, compliance, and alignment across R&D, QC, and manufacturing sites.
Compensation
Competitive compensation aligned with your knowledge and experience. 3% year-end payment and an annual bonus based on individual and company performance.
Responsibilities
Act as sparring partner for R&D during early assay development
Prepare and execute transfer plans with timelines and milestones
Lead risk/gap assessments and review transfer documentation
Align with stakeholders on method readiness and acceptance criteria
Serve as SME for LM bioanalytical methods
Requirements
Bachelor of Applied Science (BSc) or Master of Science (MSc) in Biochemistry, Biology, Molecular Biology, or related field
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