Overview
The Senior Analyst I in the Analytical Team is responsible for driving results in a fast-paced environment by performing routine and non-routine analytical testing to support the development of particulate-based drug delivery systems. These systems include microspheres for sustained release, nanoparticles for targeted drug release, and lipid nanoparticles for nucleic acid delivery. Responsibilities include developing and executing analytical assays to characterize particle size, API content, encapsulation efficiency, nucleic acid quantitation and integrity, in vitro release, and dissolution. Key analytical methodologies applied include HPLC, Capillary Electrophoresis, Gel Electrophoresis, ELISA, fluorescent microplate-based assays (RiboGreen, PicoGreen, etc.), and dissolution/in vitro release. This role requires the ability to work independently and collaboratively across multiple departments (Operations, Analytical Services, Process Development) and client-facing interactions. The Senior Analyst I will be responsible for supporting multiple projects in parallel to facilitate project teams’ ability to successfully meet project objectives in a timely and organized fashion.
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.
- 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.
- Other duties as assigned
Supervisory Responsibilities
- Act as direct line manager for junior analysts.
- Conduct performance evaluations and provide constructive feedback.
- Oversee daily activities and ensure adherence to project timelines.
- Foster a collaborative and supportive work environment.
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.
Additional Notes
- This position requires working in a laboratory environment with potential exposure to chemicals
- The role may involve standing for extended periods and performing repetitive tasks.
- This role may involve working outside standard office hours (9.00-5.30 pm) occasionally to meet project needs.
