Analytical Scientist — Method Development & QbD Expert

piramalpharma; Sellersville (Bucks County); On-site; USD 75,000 - 105,000; Full time

Job description

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

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.