What are the responsibilities and job description for the Sr. Analytical Scientist position at Clinical Resource Network (CRN)?
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
Education & Experience
Laboratory Environment
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.
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
- 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
- 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
- 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
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
- 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
- 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
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
- 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
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.
