- Design and manage analytical approaches to support process development with a focus on chromatographic and dissolution-based methods.
- Oversee and review the planning development execution and interpretation of analytical studies performed by other scientists in a collaborative matrixed environment.
- Lead the development validation and transfer of robust analytical methods ensuring high-quality data generation and reproducibility.
- Manage stability studies to assess degradation pathways and establish shelf-life parameters.
- Develop impurity control strategies to ensure product quality and regulatory compliance.
- Collaborate cross-functionally to identify and apply optimal analytical techniques including 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.
- Maintain compliance with GLP/GMP standard and safety protocols
Technical Expertise:
- Extensive hands-on experience with HPLC/UPLC dissolution testing and data review in a pharmaceutical R&D setting.
- Familiarity with a broad range of analytical techniques including SFC disintegrations compendial testing (e.g. excipients packaging release testing) generic testing (e.g. UV ICP-MS titrations)
- Proficiency in analytical instrumentation and troubleshooting
Qualifications :
Basic Qualifications:
- PhD in Chemistry or related field with 3 years of pharmaceutical R&D experience or a B.S./M.S. with 15
- Strong oral and written communication skills.
- Experience in a regulated laboratory environment (GLP/GMP).
- Proven ability to mentor team members.
Preferred Qualifications:
- Familiarity with regulatory documentation and submission processes (e.g. IND NDA CTD)
- Experience with data visulization and modeling tools to support analytical decision making.
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 :
No
Employment Type :
Full-time
Design and manage analytical approaches to support process development with a focus on chromatographic and dissolution-based methods.Oversee and review the planning development execution and interpretation of analytical studies performed by other scientists in a collaborative matrixed environment.Le...
- Design and manage analytical approaches to support process development with a focus on chromatographic and dissolution-based methods.
- Oversee and review the planning development execution and interpretation of analytical studies performed by other scientists in a collaborative matrixed environment.
- Lead the development validation and transfer of robust analytical methods ensuring high-quality data generation and reproducibility.
- Manage stability studies to assess degradation pathways and establish shelf-life parameters.
- Develop impurity control strategies to ensure product quality and regulatory compliance.
- Collaborate cross-functionally to identify and apply optimal analytical techniques including 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.
- Maintain compliance with GLP/GMP standard and safety protocols
Technical Expertise:
- Extensive hands-on experience with HPLC/UPLC dissolution testing and data review in a pharmaceutical R&D setting.
- Familiarity with a broad range of analytical techniques including SFC disintegrations compendial testing (e.g. excipients packaging release testing) generic testing (e.g. UV ICP-MS titrations)
- Proficiency in analytical instrumentation and troubleshooting
Qualifications :
Basic Qualifications:
- PhD in Chemistry or related field with 3 years of pharmaceutical R&D experience or a B.S./M.S. with 15
- Strong oral and written communication skills.
- Experience in a regulated laboratory environment (GLP/GMP).
- Proven ability to mentor team members.
Preferred Qualifications:
- Familiarity with regulatory documentation and submission processes (e.g. IND NDA CTD)
- Experience with data visulization and modeling tools to support analytical decision making.
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 :
No
Employment Type :
Full-time
View more
View less