Sr. Analytical Scientist

We are seeking an experienced Senior Analytical Scientist to drive method development and validation for pharmaceutical products while leading analytical teams. This role combines hands-on technical expertise with leadership responsibilities, supporting both research initiatives and regulatory compliance across all stages of product development.

Responsibilities:

Method Development & Validation

• Design, develop, and validate analytical methods for raw materials, in-process samples, and finished pharmaceutical products
• Create comprehensive development and validation documentation to support regulatory submissions
• Utilize advanced instrumentation including HPLC, UHPLC, LC-MS, dissolution apparatus, and GC systems
• Focus on potency testing, dissolution studies (extended-release formulation experience highly valued), impurity/degradation analysis, and residual solvent testing

Documentation & Regulatory Support

• Prepare technical documents, procedures, and methods in compliance with regulatory requirements
• Author CMC sections in CTD format for ANDA and NDA submissions
• Support regulatory filings with high-quality analytical documentation

Team Leadership & Development

• Lead cross-functional analytical project teams and coordinate activities to meet project objectives
• Manage workflow prioritization and resource allocation across multiple concurrent projects
• Provide mentorship, training, and technical guidance to junior scientists and QC analysts
• Represent the Analytical Sciences group in customer meetings and internal project discussions
• Make strategic decisions to advance project timelines and deliverables

Technical Support & Collaboration

• Support formulation development teams and clinical supplies testing programs
• Execute method transfers to internal QC departments and external partners
• Contribute to stability programs and ongoing analytical support initiatives
• Maintain regular communication with management regarding project progress and emerging challenges

Required Qualifications:

Education & Experience

• PhD in Chemistry, Analytical Chemistry, or related field with 6+ years pharmaceutical laboratory experience, OR
• Master's degree with 10+ years relevant pharmaceutical experience, OR
• Bachelor's degree with 12+ years relevant pharmaceutical experience

Technical Skills

• Expert knowledge of pharmaceutical operations including GMP compliance, laboratory procedures, and analytical equipment
• Proficiency with regulatory documentation (ANDA, NDA, DMF, IND submissions)
• Advanced Microsoft Office suite capabilities
• Comprehensive understanding of laboratory safety protocols

Professional Competencies

• Outstanding written and verbal communication skills
• Proven ability to lead and contribute effectively within cross-functional teams
• Strong project management skills with ability to prioritize and manage multiple concurrent projects independently
• Exceptional attention to detail and organizational capabilities
• Demonstrated leadership and mentoring experience

Physical Requirements

Laboratory Environment

• Ability to perform standard laboratory activities including standing, walking, reaching, bending, pushing, and pulling
• Comfortable working with personal protective equipment (PPE) in various conditions including high-noise environments, chemical exposure, and areas with dust, mists, or fumes
• Occasional lifting and moving of laboratory equipment and materials

Technical Dexterity

• Capability to climb ladders or steps to access equipment when necessary
• Excellent manual dexterity and physical coordination for handling precision laboratory instruments
• Strong visual acuity for reading measuring equipment, gauges, thermometers, and microscopic observations

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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