Scientist III, Analytical R/D

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.

Responsibilities

• 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.
• 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
• 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

Requirements

• 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 diagnosing and troubleshooting HPLC instrumentation, and addressing OOS and OOT results
• 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

Preferred

• Experience developing methods for topical drug products is a plus
• 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

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.