Analytical Scientist / Sr. Scientist

We are seeking a skilled Analytical Scientist II or Senior to join our laboratory team. This role focuses on supporting formulation development through comprehensive analytical testing, method development, and validation activities for both generic (ANDA) and new drug application (NDA) projects. Responsibilities :

Method Development & Validation

Design, develop, and optimize analytical test methods for raw materials, in-process samples, and finished pharmaceutical products

Execute method verification and validation studies following established protocols, company procedures, FDA guidance documents, and ICH guidelines

Document all analytical work comprehensively to ensure regulatory compliance

Testing & Analysis

Perform chemical and physical characterization of APIs, raw materials, in-process samples, and finished products

Conduct routine product release testing and stability studies using validated analytical methods

Support formulation development teams through timely and accurate analytical data generation

Documentation & Communication

Author technical protocols, validation reports, and analytical documentation

Collaborate effectively with cross-functional teams including Formulation Development, Quality Control, Quality Assurance, Compliance, and Regulatory Affairs

Maintain clear communication channels to support project timelines and objectives

Compliance & Professional Development

Adhere to current Good Manufacturing Practice (cGMP) regulations and company standard operating procedures

Participate in ongoing training programs covering SOPs, laboratory safety, and current scientific methodologies

Stay current with FDA guidance documents and ICH guidelines relevant to analytical testing

Required Qualifications :

Education & Experience

Bachelor's degree in Chemistry, Chemical Engineering, Materials Science, or related scientific discipline

Minimum 5 years of relevant analytical laboratory experience

Level (II vs Senior) determined by depth of experience and demonstrated expertise

Technical Skills

Strong foundation in analytical chemistry principles and physical characterization techniques

Proven experience in analytical method development and optimization

Working knowledge of GMP requirements, ICH guidelines, and FDA regulatory expectations

Professional Skills

Excellent written and verbal communication abilities

Strong interpersonal skills for effective cross-functional collaboration

Detail-oriented approach with strong documentation practices

Ability to work independently while supporting team objectives

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