Analysis Skills, Analytical Method Development, Analytical Method Validation, Calibration, Communication Skills, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Processing, Data Quality, Drug Development, Drug Products, Equipment Maintenance/Repair, Experiment Design, FDA (Food and Drug Administration), Fourier-Transform Infrared Spectroscopy (FTIR), GMP (Good Manufacturing Practices), High Performance Liquid Chromatography (HPLC), ICH Regulations, Identify Issues, Instrumentation, Laboratory Equipment, Laboratory Management, Laboratory Notebook, Manufacturing, Microscopy, Microsoft Office, Organizational Skills, Physical Demands, Process Development, Project/Program Management, Quality Assurance, Quality Control, Regulatory Compliance, Reporting Skills, Research & Development (R&D), Safety/Work Safety, Stability Analysis, Technical Writing, Testing, Validation Plan, Writing Skills
Scientist II
Full Time | Onsite | Durham, NC
Position Summary
The Scientist II, Analytical R&D, is responsible for developing and validating analytical methods to support drug formulation development in a GMP-compliant laboratory under supervision. This role includes performing method validations, stability testing, and forced degradation studies while ensuring data integrity and regulatory compliance. The scientist will manage projects, including the experimental design and execution of stability sampling and validation parameters, as well as associated reporting. Responsibilities also include authoring technical documents—such as method validation protocols and reports—under supervision and troubleshooting analytical instrumentation such as HPLC and GC. Additionally, this role requires collaboration with cross-functional teams, including Formulation R&D, Quality Control, and Quality Assurance, while maintaining a safe and well-organized laboratory environment.
Essential Functions
- Develop/validate analytical methods to support formulation drug development under supervision
- Perform routine testing including stability testing, solubility studies, and Drug-Excipient Compatibility studies
- Perform post manufacturing studies such as freeze thaw, photostability and In use testing studies
- Perform forced degradation studies and other method development activities under supervision
- Execute routine instrument troubleshooting, peer review of laboratory notebooks, maintenance of logbooks
- Under management supervision - co-author analytical methods, protocol, reports, and development reports
- Maintain laboratory equipment, including calibration scheduling, acquisition and basic maintenance programs
- Maintain a GMP-compliant analytical laboratory and safe working environment
- Process and generate data packs on a daily basis
- Review laboratory notebooks, data packs, and reports as directed
- Material sourcing for reagents, columns, standard and lab supplies as needed
Supervisory responsibilities:
- Direct Reports: None
- Indirect Reports: None
Key Relationships (examples: Depts or Individual positions that this position will be working closely with):
- Process Development/ Formulation R&D
- Quality Control
- Quality Assurance
Education and Experience
- B.S., with 6 years', M.S., with 4-6 years' experience
- 2 years’ experience in a GMP laboratory setting
- Proven experience developing and validating GMP-compliant HPLC and GC methods to assess drug product stability
- Experience Developing methods for topical products is a plus.
- Experience diagnosing and troubleshooting HPLC instrumentation, and addressing OOS and OOT results
- Experience with operation of HPLC and Karl Fisher
- Experience with Empower software
- Experience with UV, FTIR, optical microscopy, PSD, Viscosity, and rheological methodology a plus
- Experience diagnosing and troubleshooting HPLC instrumentation is a plus
Knowledge, Skills, and Abilities
- Knowledge of cGMP regulations and ICH, USP, and FDA guidelines
- Speaks, writes, listens, and presents information in a logical and articulate manner appropriate for the audience
- Experience with software such as MasterControl and MS Office preferred
- Thorough when performing work, conscientious about attending to detail, and uses logical thinking that is well-organized and methodical
Physical Demands and Work Environment
While performing the duties of this job, there may be certain physical demands required for the position.
- Requires constant standing, walking, seeing, hearing, & gripping
- Requires frequent sitting, bending, & reaching
- Requires frequent carrying, lifting, pushing, & pulling, occasionally under 20 LBS
- Requires occasional twisting
- May be exposed to moderate noise levels in a climate-controlled lab environment
Other Duties
You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.
Limitations and Disclaimer
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. The Company is committed to making reasonable adjustments to the workplace to ensure the role is accessible to all candidates, including those with disabilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.
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