Analytical Scientist

Piramal Pharma Ltd; Sellersville (Bucks County); On-site; USD 65,000 - 95,000; Full time

Job summary

Piramal Pharma Solutions in the United States seeks an Analytical Scientist to develop, validate and transfer analytical methods for NCEs and generics in solid and liquid dosage forms.

The role emphasizes applying QbD principles, supporting development teams, conducting stability testing, and ensuring data integrity across projects.

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 dosage forms, 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 analytical methods for a diverse portfolio of NCEs and generic drug products in solid and liquid dosage forms.
• Apply Quality by Design (QbD) principles to analytical method development and prepare supporting documentation.
• Work with analytical methods including cleaning verification, assay and related substances, dissolution studies and related assessments.
• Develop methodologies to support product development teams with mitigation insights.
• Perform initial and stability testing for R&D and demonstration batches.
• Review data for technical correctness and interpret results accurately.

Skills

Analytical method development

Client-facing experience

Data interpretation

Education

Bachelor’s degree in chemistry, pharmaceutical sciences, or related field

Tools

HPLC/GC instruments

Dissolution testing

Solid-state characterization

Job description

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. For more details, please visit : www.piramalpharmasolutions.com

Job Title

Analytical Scientist

Job Description

The incumbent for this position will be responsible for the development and validation of analytical methodologies and performance of tasks using chromatographic, spectroscopic, solid-state, and physical/wet-chemical techniques.

• 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.– 30%
• 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 – 20%
• 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 – 10%
• Developing analytical methodologies to complete all related activities and provide insights to product development teams on mitigation strategies – 20%
• Perform initial and stability testing for R&D batches and demonstration batches to support formulation development – 10%
• Review/analyze data and information for technical correctness and accuracy; interpret and evaluate results properly – 10%

Qualifications

• Bachelor’s degree in chemistry, pharmaceutical sciences, or related field required, master’s preferred.
• 2+ years’ experience developing analytical methods for New Chemical Entities (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.