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Position Summary
The Scientist III/ Sr. Scientist is responsible for developing and validating analytical methods to support drug formulation development in a GMP-compliant laboratory. This role involves 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 include 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.
Essential Functions
• 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 and when needed
• Ability to 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
• Author/ Co-author analytical methods, validation and transfer protocols, instrument qualification protocols, validation/qualification reports, SOPs, etc.
• Execute routine instrument troubleshooting, peer review of laboratory notebooks, maintenance of logbooks
• Maintain laboratory equipment, including calibration scheduling, acquisition, and basic maintenance programs
• Maintain a GMP-compliant analytical laboratory and safe working environment, maintain lab inventory
• Review laboratory notebooks, data packs, and reports under minimal supervision. Trend stability data.
• Present data to the customers, attend client meetings as needed under minimal guidance
• Supervise, mentor, train and develop junior scientists
Supervisory responsibilities:
Direct Reports: No; Indirect Reports: Yes
Key Relationships (examples: Depts or Individual positions that this position will be working closely with):
• Process Development/ Formulation R&D
• Quality Control
• Quality Assurance
Travel requirements: N/A
Education and Experience
• B.S., with 8+ years', M.S., with 6+ years' experience, Ph.D.: focus in chemistry, biology, pharmaceutics
• 4+ years' 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 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
• Technical report writing proficiency preferred
• 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.
• Occasionally required to lift/carry up to 20lbs
• 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
Other Duties
You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.