Eurofins USA PSS Insourcing Solutions
Pharmaceutical Analytical Project Analyst
Eurofins USA PSS Insourcing Solutions, Groton, Connecticut, us, 06349
Job Description
Design and guide analytical strategies to support manufacturing process development.
Lead the planning, development, execution, and data interpretation performed by other scientists in a collaborative, matrixed environment.
Oversee and review the development, validation, and transfer of analytical methods to ensure robust and reliable data generation.
Manage stability studies to assess degradation pathways and establish shelf-life parameters.
Develop impurity control strategies to ensure product quality and regulatory compliance.
Experience with a wide range of analytical testing including dissolution, HPLC/UPLC, SFC, disintegration, compendial testing (e.g., excipients / packaging release testing), generic testing (e.g., solvents, water, ash, titrations, heavy metals, ICP/MS, UV) and compound specific methods
Collaborate with cross-functional teams to identify and apply the most effective analytical techniques, including the use of computational modeling, predictive tools, and data visualization platforms.
Evaluate scientific data to draw clear conclusions, guide future work, and communicate findings through presentations, technical reports, and other media.
Contribute to regulatory submissions by authoring relevant sections of the quality modules, ensuring alignment with global standards and expectations.
Maintain compliance with GLP/GMP standard and safety protocols
Qualifications: Qualifications
PhD in Chemistry, or related field, with 3+ years of pharmaceutical R&D experience or a B.S./M.S. with 15+ years
Strong oral and written communication skills.
Experience in a regulated laboratory environment (GLP/GMP).
Proven ability to lead scientific projects and mentor team members.
Proficiency in analytical instrumentation and techniques.
Familiarity with regulatory documentation and submission processes.
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.
Design and guide analytical strategies to support manufacturing process development.
Lead the planning, development, execution, and data interpretation performed by other scientists in a collaborative, matrixed environment.
Oversee and review the development, validation, and transfer of analytical methods to ensure robust and reliable data generation.
Manage stability studies to assess degradation pathways and establish shelf-life parameters.
Develop impurity control strategies to ensure product quality and regulatory compliance.
Experience with a wide range of analytical testing including dissolution, HPLC/UPLC, SFC, disintegration, compendial testing (e.g., excipients / packaging release testing), generic testing (e.g., solvents, water, ash, titrations, heavy metals, ICP/MS, UV) and compound specific methods
Collaborate with cross-functional teams to identify and apply the most effective analytical techniques, including the use of computational modeling, predictive tools, and data visualization platforms.
Evaluate scientific data to draw clear conclusions, guide future work, and communicate findings through presentations, technical reports, and other media.
Contribute to regulatory submissions by authoring relevant sections of the quality modules, ensuring alignment with global standards and expectations.
Maintain compliance with GLP/GMP standard and safety protocols
Qualifications: Qualifications
PhD in Chemistry, or related field, with 3+ years of pharmaceutical R&D experience or a B.S./M.S. with 15+ years
Strong oral and written communication skills.
Experience in a regulated laboratory environment (GLP/GMP).
Proven ability to lead scientific projects and mentor team members.
Proficiency in analytical instrumentation and techniques.
Familiarity with regulatory documentation and submission processes.
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.