Scientist

Planet Pharma; Cambridge (MA); On-site; USD 50,000 - 54,000; Full time

Job summary

Planet Pharma in Cambridge, MA is seeking an Analytical Scientist to develop and implement pioneering analytical methods for impurity release testing, and to generate and interpret data supporting product development investigations and regulatory submissions.

The role requires expertise in ELISA, qPCR, DNA isolation, GDP documentation, and the use of Electronic Laboratory Notebook systems, with strong communication and collaboration skills to support cross-functional teams.

Qualifications

• Master’s degree (or Bachelor’s with 4 years of scientific experience) in a life-science field.
• 2+ years of scientific experience for Master’s track; 4+ years for Bachelor’s track.

Responsibilities

• Develop and implement analytical methods for impurity release testing.
• Generate and interpret analytical data to support product development investigations and regulatory submissions.
• Support analytical projects involving method development, qualification, and transfer.
• Provide critical evaluation of analytical data to support regulatory submissions and investigations.
• Contribute to analytical development teams with updates and documentation.

Skills

ELISA

qPCR

DNA isolation

GDP documentation

Electronic Laboratory Notebook

Microsoft Office

analytical data interpretation

communication

Education

Master’s degree in Science

Bachelor’s degree in Science with 4 years of scientific experience

Tools

GDP documentation systems

Job description

• Developing and implementing pioneering and fit-for-purpose analytical methods for: impurity release testing.
• Generating, analyzing, and interpreting analytical data to support: product development investigations, and regulatory submissions
• Keeps current in analytical development field including literature and technology development for groundbreaking and regulatory activities
• Supporting analytical projects involving method development, qualification, and transfer
• Provides critical evaluation of analytical data and results to support: product development (for Process Development, Quality, etc.), investigations and regulatory submissions
• Participates in and contributes to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates and documentation.

Basic Qualifications

Master’s degree & 2 years of Scientific experience

OR

Bachelor’s degree & 4 years of Scientific experience

Preferred Qualifications:

• Experience and expertise with protein assays, particularly ELISA as well as most common formats for measuring protein-protein interactions.
• Experience and expertise with molecular biology, particularly qPCR and DNA isolation.
• Experience with GDP documentation and Electronic Laboratory Notebook systems.
• Experience and expertise with Microsoft Office software, particularly Word, PowerPoint and Excel.
• Experience with ICH Guidelines
• Innovation – positive approach to challenges; champions new insights and initiatives; brings out and applies others’ creativity to improve unit performance
• Communication – establishes and maintains effective communication mechanisms to keep staff appropriately advised; bridges communication between individuals, units and other organizations as necessary
• Social skills – communicates optimally, using appropriate tact and sensitivity; makes others feel respected, valued and understood

Pay Range: $36-39/hr* Based on Experience