Analytical Scientist

Piramal Pharma Limited; Sellersville (Bucks County); On-site; USD 70,000 - 95,000; Full time

Job summary

Piramal Pharma Solutions is seeking an Analytical Scientist to develop and validate analytical methodologies using chromatographic, spectroscopic, solid-state, and wet-chemical techniques. The incumbent will support a diverse portfolio across solid and liquid oral dosage forms.

Responsibilities include method development and transfer, QbD implementation, and documentation. The role requires 2+ years of experience and a relevant bachelor's degree, with opportunities to contribute to product

Qualifications

• Bachelor's degree in chemistry, pharmaceutical sciences, or related field; master's preferred.
• 2+ years’ experience developing analytical methods for NCEs and generic drugs in solid and liquid dosage forms.
• Familiarity with chromatographic (HPLC/GC), dissolution, spectroscopic, and solid-state characterization techniques preferred.
• Experience in a client-facing role as the primary contact for external partners on projects.

Responsibilities

• Develop, validate, and transfer analytical methods for NCEs and generics in solid and liquid oral dosage forms.
• Implement QbD principles to analytical method development and prepare necessary documentation.
• Work with methods including dissolution, residual solvents, and finished product analysis.
• Develop methodologies to provide insights to product development teams on mitigation strategies.
• Perform initial and stability testing for R&D batches and demonstration batches.
• Review data and interpret results for technical accuracy.

Skills

Analytical methods

HPLC/GC

QbD

Method transfer

Education

Bachelor's in Chemistry/Pharma

Master's preferred

Tools

HPLC

GC

Dissolutions

Spectroscopy

Solid-state analysis

Job description

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Division

Piramal Pharma SolutionsPiramal 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 dataand 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.
• Experiencein a client-facing role, serving as the primary point of contact for external partners on projects.