Analytical Project Lead

Groton, MA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Work in a GLP or GMP environment with appropriate documentation and safety practices
Lead the development and execution of analytical strategies for new drug product candidates
Plan direct and review laboratory work including method development validation and transfer
Design and interpret stability studies to understand degradation mechanisms and support shelf-life assignments.
Develop impurity control strategies aligned with regulatory expectations.
Collaborate with formulations process and regulatory teams to ensure seamless pharmaceutical drug development
Collaborate with colleagues to identify appropriate analytical approaches including use of computational predictive tools modeling software and data visualization tools where appropriate
Critically review and interpret scientific data to derive clear conclusions and provide direction for future work
Mentor and guide junior scientists in analytical techniques and data interpretation.
Evaluate and implement new strategies as needed e.g. working with external partners
Communicate results and conclusions through various media including presentations and technical reports
Author relevant sections of the quality modules of regulatory submissions

Qualifications :

Ph.D. in Analytical Chemistry or related field with 5-7 years of pharmaceutical R&D experience or B.S./M.S. with 15 years of pharmaceutical R&D experience required
Proven expertise in a broad range of analytical techniques e.g. chromatography mass spectrometry dissolution spectroscopy NMR and data analysis
Strong understanding of regulatory requirements and experience with regulatory filings
Experience with method transfer and working with external partners
Proficiency in scientific software data systems and modeling tools
Demonstrated leadership problem-solving and mentoring capabilities
DESIRED QUALIFICATIONS:
Experience with mathematical modeling or coding

Additional Information :

Position is full-time Monday-Friday 8:00 am - 5:00 pm.
Candidates currently living within a commutable distance of Groton CT are encouraged to apply
Excellent full-time benefits including comprehensive medical coverage dental and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
#LI-EB1
Authorization to work in the United States indefinitely without restriction or sponsorship

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

Employment Type :

Full-time

Work in a GLP or GMP environment with appropriate documentation and safety practices Lead the development and execution of analytical strategies for new drug product candidates Plan direct and review laboratory work including method development validation and transfer Design and interpret stability ...

Work in a GLP or GMP environment with appropriate documentation and safety practices
Lead the development and execution of analytical strategies for new drug product candidates
Plan direct and review laboratory work including method development validation and transfer
Design and interpret stability studies to understand degradation mechanisms and support shelf-life assignments.
Develop impurity control strategies aligned with regulatory expectations.
Collaborate with formulations process and regulatory teams to ensure seamless pharmaceutical drug development
Collaborate with colleagues to identify appropriate analytical approaches including use of computational predictive tools modeling software and data visualization tools where appropriate
Critically review and interpret scientific data to derive clear conclusions and provide direction for future work
Mentor and guide junior scientists in analytical techniques and data interpretation.
Evaluate and implement new strategies as needed e.g. working with external partners
Communicate results and conclusions through various media including presentations and technical reports
Author relevant sections of the quality modules of regulatory submissions

Qualifications :

Ph.D. in Analytical Chemistry or related field with 5-7 years of pharmaceutical R&D experience or B.S./M.S. with 15 years of pharmaceutical R&D experience required
Proven expertise in a broad range of analytical techniques e.g. chromatography mass spectrometry dissolution spectroscopy NMR and data analysis
Strong understanding of regulatory requirements and experience with regulatory filings
Experience with method transfer and working with external partners
Proficiency in scientific software data systems and modeling tools
Demonstrated leadership problem-solving and mentoring capabilities
DESIRED QUALIFICATIONS:
Experience with mathematical modeling or coding

Additional Information :

Position is full-time Monday-Friday 8:00 am - 5:00 pm.
Candidates currently living within a commutable distance of Groton CT are encouraged to apply
Excellent full-time benefits including comprehensive medical coverage dental and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
#LI-EB1
Authorization to work in the United States indefinitely without restriction or sponsorship

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

Employment Type :

Full-time

Key Skills

Airside Operations
Accountancy
Data Warehousing
Actuary
Import & Export
Corrosion

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About Company

Eurofins

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eur ... View more

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