Scientist III, Analytical R​/D

The Scientist III / Senior Scientist is responsible for developing and validating analytical methods to support drug formulation development in a GMP‑compliant laboratory. This role includes performing validations, stability testing, and forced degradation studies while ensuring data integrity and regulatory compliance. The scientist will independently manage projects, including literature reviews, experimental design, execution, and reporting. Responsibilities also encompass authoring technical documents such as method validation protocols, development reports, and SOPs, as well as troubleshooting analytical instrumentation like HPLC and GC.

Additionally, the role requires mentoring junior scientists, collaborating with cross‑functional teams such as Formulation R&D, Quality Control, and Quality Assurance, and maintaining a safe, well‑organized laboratory environment.

• Develop and validate analytical methods to support formulation drug development under minimal supervision.
• Perform routine testing including stability testing, solubility studies, and drug‑excipient compatibility studies as needed.
• Own projects independently, including literature review, material sourcing, design experiments, executing/delegating tasks, and providing data to customers.
• Perform forced degradation studies.
• Author product development reports and investigation reports.
• Contribute to analytical methods, validation and transfer protocols, instrument qualification protocols, validation/qualification reports, SOPs, etc.
• Execute routine instrument troubleshooting, peer review of laboratory notebooks, and maintain logbooks.
• Maintain laboratory equipment, including calibration scheduling, acquisition, and basic maintenance programs.
• Maintain a GMP‑compliant analytical laboratory and safe working environment, and maintain lab inventory.
• Review laboratory notebooks, data packs, and reports under minimal supervision; trend stability data.
• Present data to customers and attend client meetings as needed under minimal guidance.
• Supervise, mentor, train, and develop junior scientists.

• Process Development / Formulation R&D
• Quality Control
• Quality Assurance

• B.S. with 8+ years of experience, M.S. with 6+ years of experience, Ph.D. with focus in chemistry, biology, or pharmaceutics.
• 4+ years of experience in a GMP laboratory setting.
• Proven track record developing and validating GMP‑compliant HPLC and GC methods to assess drug product stability.
• Experience developing methods for topical drug products is a plus.
• Experience diagnosing and troubleshooting HPLC instrumentation, and addressing OOS and OOT results.
• Experience with the operation of HPLC and GC.
• Experience with Empower 3 software.
• Experience with UV, FTIR, KF, optical microscopy, PSD, viscosity, and rheological methodology is a plus.

• Knowledge of cGMP regulations and ICH, USP, and FDA guidelines.
• Strong communication skills: speaks, writes, listens, and presents information logically and articulately.
• Technical report writing proficiency preferred.
• Experience with software such as Master Control and MS Office preferred.
• Thorough when performing work; detail‑oriented; logical and methodical thinker.

• Occasionally required to lift/carry up to 20 lbs.
• Requires standing/walking for extended periods in a climate‑controlled lab environment.
• Frequent bending, lifting, pushing, pulling, carrying, and sitting may be required.
• May be exposed to moderate noise levels in a climate‑controlled lab environment.

May be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.