Scientist

Aditi Consulting; Cambridge (MA); On-site; USD 45,000 - 65,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) plan with employer match

Paid time off ( PTO)

Job summary

Aditi Consulting is seeking an analytical development scientist to develop and implement methods for impurity release testing. You will generate and interpret analytical data to support product development investigations and regulatory submissions.

The role requires staying current with analytical developments and supporting method development, qualification, and transfer activities. The candidate should have a Master’s with 2 years or a Bachelor’s with 4 years of experience, with preferred

Qualifications

• Master’s degree & 2 years of scientific experience OR Bachelor’s degree & 4 years of scientific experience.
• Experience with protein assays, ELISA, and molecular biology.
• GDP documentation and ELN systems experience.
• MS Office proficiency (Word/PowerPoint/Excel).
• ICH guidelines familiarity and data interpretation skills.

Responsibilities

• Develop and implement analytical methods for impurity release testing.
• Generate, analyze, and interpret analytical data to support product development investigations and regulatory submissions.
• Stay current in analytical development field and apply literature/tech developments.
• Support method development, qualification, and transfer projects.
• Provide evaluation of analytical data for process development and regulatory submissions.
• Participate in analytical development teams with documentation updates.

Skills

Analytical mindset

Communication skills

Education

Master’s degree with 2 years experience

Bachelor’s degree with 4 years experience

Tools

ELISA

qPCR

GDP documentation

Electronic Laboratory Notebook

MS Office (Word/Excel/PowerPoint)

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.

Payrate: $40.00 - $40.00/hr.

Responsibilities

• 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 Transparency

The typical base pay for this role across the U.S. is: $40.00 - $40.00/hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages.

• medical, dental, and vision benefits
• health savings accounts with qualified medical plan enrollment
• 10 paid days off
• 3 days paid bereavement leave
• 401(k) plan participation with employer match
• life and disability insurance
• commuter benefits
• dependent care flexible spending account
• accident insurance
• critical illness insurance
• hospital indemnity insurance
• accommodations and reimbursement for work travel
• discretionary performance or recognition bonus
• Sick leave and mobile phone reimbursement provided based on state or local law.