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

If you meet the required qualifications and are interested in this role, please apply today.

Clinical Resource Network Distinction

CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.

About CRN

Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit https://www.solomonpage.com/crn and connect with us on Facebook and LinkedIn.

Opportunity Awaits.

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