Analytical Scientist

Piramal PharmaSellersville, PA
Onsite

About The Position

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. They serve clients through a globally integrated network of facilities in North America, Europe, and Asia, providing services such as Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms, and specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. The Analytical Scientist 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.

Requirements

  • Bachelor’s degree in chemistry, pharmaceutical sciences, or related field required.
  • 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.
  • Experience in a client-facing role, serving as the primary point of contact for external partners on projects.

Nice To Haves

  • Master’s degree preferred.
  • Familiarity with chromatographic (HPLC/GC), Dissolutions, spectroscopic, and solid-state characterization techniques preferred.

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.
  • Develop 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.
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