Analytical Scientist

Piramal Pharma Limited; Sellersville (Bucks County); On-site; USD 80,000 - 120,000; Full time

Job summary

Piramal Pharma Limited, within Piramal Pharma Solutions, is seeking an Analytical Scientist to develop and validate analytical methodologies for NCEs and generics. You will transfer methods and support QC and development teams across solid and liquid dosage forms.

Key activities include applying QbD principles, performing dissolution and related analyses, and delivering robust scientific documentation. A client-facing mindset and strong data interpretation are essential.

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 analytical methods for a diverse portfolio of 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

Skills

Analytical method development

Client liaison

Data interpretation

Education

Bachelor's degree in chemistry or pharmaceutical sciences

Tools

HPLC/GC

Dissolutions

Spectroscopy

Solid-state characterization

Job description

Be the First to Apply 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

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.

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.