Analytical Scientist: Protein Assays & Regulatory Support

Aequor-a6ad214d; Cambridge (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Fives DyAG Corp. is seeking an analytical development scientist in Cambridge, MA to design and implement innovative methods for impurity release testing.

The role involves generating and interpreting data to support product development investigations and regulatory submissions, while staying current with literature and technology developments. You will participate in cross-functional analytical development teams, collaborating to provide updates, document results, and help transfer methods to

Qualifications

• Master's degree with 2 years of scientific experience OR Bachelor's degree with 4 years of scientific experience.
• Experience with protein assays, particularly ELISA and protein-protein interactions.
• Experience with GDP documentation and ELN systems.

Responsibilities

• Develop and implement analytical methods for impurity release testing.
• Generate, analyze, and interpret analytical data to support product development investigations and regulatory submissions.
• Maintain current knowledge in analytical development and regulatory activities.
• Support analytical projects involving method development, qualification, and transfer.
• Provide critical evaluation of analytical data to support product development, investigations, and regulatory submissions.
• Participate in analytical development teams by providing updates and documentation.

Skills

ELISA assays

qPCR

DNA isolation

GDP documentation

Microsoft Office

ICH Guidelines

Data interpretation

Communication

Team collaboration

Education

Master's degree

Bachelor's degree

Tools

Electronic Laboratory Notebook (ELN)

Job description

Job Description
Responsibilities include:
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

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