Analytical Scientist: NCE Method Development & Validation

Piramal Pharma Ltd; Sellersville (Bucks County); On-site; USD 85,000 - 110,000; Full time

Job summary

Piramal Pharma Solutions in the United States seeks an Analytical Scientist to develop and validate analytical methods for a diverse portfolio of NCEs and generic drugs across solid and liquid oral dosage forms.

The role involves applying QbD principles, preparing technical documentation, and collaborating with external partners in a regulated pharmaceutical environment. A strong background in chromatographic, spectroscopic, and solid-state techniques is preferred.

Qualifications

• Bachelor’s degree in chemistry, pharmaceutical sciences, or related field required, master’s preferred.
• 2+ years’ experience developing analytical methods for NCEs and generic drug products in solid and liquid oral dosage forms, such as tablets, capsules, suspensions, and solutions, within a regulated pharmaceutical environment.
• Familiarity with chromatographic (HPLC/GC), Dissolutions, spectroscopic, and solid-state characterization techniques preferred.
• Experience in a client-facing role, serving as the primary point of contact for external partners on projects.

Responsibilities

• Develop, validate, and transfer of analytical methods for a diverse portfolio of New Chemical Entities (NCEs) and generic drug products in solid and liquid oral dosage forms, including tablets, capsules, suspensions, and solutions.
• Implement Quality by Design (QbD) principles to analytical method development to create robust and reliable methods, preparing all necessary scientific documentation—such as comprehensive reports, technical justifications, and detailed rationales—based on the findings of the QbD study
• Work with various analytical methods including cleaning verification, assay and related substances, BCS Solubility study, dissolution, discriminatory dissolution, doss dumping study, multimedia dissolution study, residual solvents in-process control, and analysis of finished products and excipients
• Developing analytical methodologies to complete all related activities and provide insights to product development teams on mitigation strategies
• Perform initial and stability testing for R&D batches and demonstration batches to support formulation development
• Review/analyze data and information for technical correctness and accuracy; interpret and evaluate results properly

Skills

Client-facing

Analytical method development

Regulatory compliance

Education

Bachelor's degree in chemistry/pharmaceutical sciences or related field

Master's degree preferred

Tools

HPLC

GC

Dissolutions

Spectroscopy

Solid-state characterization

Job description

Piramal Pharma Solutions in the United States seeks an Analytical Scientist to develop and validate analytical methods for a diverse portfolio of NCEs and generic drugs across solid and liquid oral dosage forms.

The role involves applying QbD principles, preparing technical documentation, and collaborating with external partners in a regulated pharmaceutical environment. A strong background in chromatographic, spectroscopic, and solid-state techniques is preferred.