Senior Analytical Scientist Job Hopkinton area,Massachusetts USA,Research/Development

Position: Senior Analytical Scientist I

Overview

The Senior Analytical Scientist I leads analytical testing for particulate-based drug delivery systems, including microspheres, nanoparticles, and lipid nanoparticles. 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. Applies methodologies such as HPLC, Capillary Electrophoresis, Gel Electrophoresis, ELISA, fluorescent microplate assays, and dissolution testing. The role requires independent work and cross-functional collaboration across Operations, Analytical Services, Process Development, and client-facing interactions.

The Senior Analyst I may support multiple projects in parallel to meet objectives in a timely manner.

Responsibilities

Analytical Testing and Method Validation:
Perform advanced analyses and lead method validation and transfer protocols. Independently perform method development for new projects. Conduct analytical characterization of particulate-based drug delivery systems using assays (API quantitation, lipid quantitation, etc.), particle size, dissolution and/or in vitro release, residual moisture, osmolality, and syringe ability/injectability.

Instrument Operation and Troubleshooting:
Demonstrate strong knowledge of instrument operation and troubleshooting. Independently resolve technical issues. Maintain working knowledge of instrumentation, equipment, and methodologies necessary to perform 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 to improve laboratory processes and outcomes. Assist in technical troubleshooting related to instrumentation, general chemistry, and analytical methodologies.

Data Analysis and Reporting:
Analyze, report, and trend data from method development activities. Summarize data 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 meet objectives. Engage in high-level client interaction and project management.

Project Management:
Oversee project scoping and budgeting to ensure accurate planning. Manage advanced projects to meet timelines and ensure successful completion.

Documentation and Review:
Maintain lab notebooks with detailed records. Draft, review, and approve technical documents such as SOPs, methods, and reports. Produce technical documents including drug release and stability protocols and analytical reports.

Study Design:
Independently design in vitro release and stability studies to support product development.

Service Expansion and Recommendations:
Present ideas to expand services and recommend instrument procurement to enhance laboratory capabilities. Evaluate feasibility of expansion and equipment investments.

EH&S Practices:
Adhere to EH&S protocols to maintain a safe working environment. Maintain a safe, clean, and organized workspace.

Other duties as assigned

Supervisory Responsibilities

Act as direct line manager for junior analysts. Conduct performance evaluations and provide feedback. Oversee daily activities and ensure adherence to 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. 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
Experience with fluorescent micro-plate assays (Ribo Green, Pico Green, etc), chromatography, spectroscopy, and wet chemistry methods
Experience with instruments such as HPLC, UPLC, UV/VIS, fluorescence, or multimode microplate reader, dissolution apparatus, and particle size analyzer
Experience in method development for early-stage drug development

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

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