Senior Analytical Scientist I

Role & Responsibilities

• Analytical Testing and Method Validation:
  • Perform advanced analyses and lead method validation and transfer protocols.
  • Independently perform method development for new projects.
  • Perform analytical characterization of particulate-based drug delivery systems using techniques such as assays (API quantitation, lipid quantitation, etc.), particle size, dissolution, and/or in vitro release, residual moisture, osmolality, and syringeability/injectability.
• Instrument Operation and Troubleshooting:
  • Demonstrate strong knowledge of instrument operation and troubleshooting.
  • Independently perform instrument troubleshooting to resolve technical issues.
  • Maintain working knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.
• Mentoring and Training:
  • Mentor, supervise, and train junior staff on analytical techniques and instrument operation.
  • Develop and implement training programs for junior analysts.
  • Absorb and assist in training junior/newly hired staff and interns to operate analytical instruments
• Problem Solving and Troubleshooting:
  • Lead analytical problem-solving and troubleshooting activities to improve laboratory processes and outcomes.
  • Assist analytical team with technical troubleshooting of analytical problems related to instrumentation, general chemistry, and analytical methodologies
• Data Analysis and Reporting:
  • Analyze, report, and trend data from method development activities.
  • Summarize generated data and analyze it for technical correctness and accuracy.
  • Present data internally and externally to team members, stakeholders, and clients.
• Client Interaction:
  • Interact with clients to understand project objectives and provide analytical solutions.
  • Evaluate different analytical approaches to solve client and project objectives.
  • Engage in high-level client interaction and project management.
• Project Management:
  • Oversee project scoping and costing to ensure accurate planning and budgeting.
  • Manage advanced projects to ensure adherence to timelines and successful completion.
• Documentation and Review:
  • Maintain lab notebooks with detailed and accurate records of experiments and results.
  • Draft, review, and approve technical documents such as Standard Operating Procedures (SOPs), methods, and reports.
  • Write technical documents such as SOPs, analytical methods, drug release and stability protocols, and technical reports.
• Study Design:
  • Design in vitro release and stability studies independently to support product development.
• Service Expansion and Recommendations:
  • Present service expansion ideas and instrument recommendations to enhance laboratory capabilities.
  • Evaluate service expansion ideas and instrument procurement recommendations.
• EH&S Practices:
  • Adhere to Environmental Health and Safety (EH&S) practices and protocols to maintain a safe working environment.
  • Maintain a safe, clean, and organized work environment free of safety hazards.

Requirements

• Bachelor’s degree in chemistry, pharmacy, or pharmaceutical sciences with 10-15 years of experience, a Master’s degree with -9 years of experience, or a PhD with 2-5 years of experience.
• Proficient in Microsoft Office (Word, Excel, PowerPoint)
• Strong analytical and problem-solving skills.
• Excellent attention to detail and organization skills.
• Ability to work independently and as part of a team.
• Excellent verbal and written communication skills and ability to collaborate cross-functionally.

Preferred Skills

• Experience with advanced analytical testing and data analysis
• Familiarity with laboratory safety protocols and EH&S practices.
• Knowledge of CE, HPLC, and dissolution/in vitro release testing techniques.
• Prior experience executing fluorescent micro-plate-based assays (RiboGreen, PicoGreen, etc), chromatography, spectroscopy, and wet chemistry methods.
• Prior experience with instruments such as HPLC, UPLC, UV/VIS, fluorescence, or multimode microplate reader, dissolution apparatus, and particle size analyzer.
• Prior experience in method development for early-stage drug development.
• Prior method transfer experience.