Principal Analytical Scientist - CRDMO

Posted 22 November 2022
Salary Competitive
LocationUnited States of America
DisciplineSmall Molecule
Contact NameSofia Furlan

Job description

​Mantell Associates is proudly partnering with an extremely exciting upcoming and ​rapidly growing privately owned CRDMO. This organisation provides drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry.

This organisation has an impressive growth plan and is currently investing significant capitals in a two-phase expansion projects, including building a new state-of-the-art facility adjacent to our current facility. Due to the investment they are now looking to hire a new Principal Scientist that will directly report to the head of Quality Control and will be responsible for the operational and functional leadership of the Analytical Development laboratory.

Principal Analytical Scientist Responsibilities:

  • The ideal candidate will have small molecule method development, validation and testing experience to support clinical and commercial manufacturing.

  • Identifies, evaluates, develops, and validates analytical methods for compendial, raw material, drug substance and finished product testing.

  • Provides subject matter expertise in common analytical chemistry techniques (HPLC/UPLC, LC-MS, GC etc.).

  • Leads laboratory investigations for OOT and OOS results.

  • Collaborates with project teams and customers to meet project objectives, budgets and timelines.

  • Analyses complex data sets, interprets and integrates experimental results with project objectives.   

  • Leads, coaches and mentors reports along with other team members.

  • Develops and maintains a comprehensive understanding of regulatory guidance pertaining to all aspects of drug product development.

  • Authors and executes developmental protocols and summary reports.

  • Reviews and approves data from analytical experiments.   

Principal Analytical Scientist Requirements:

  • Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Bioengineering or related field with 12+ years of relevant pharmaceutical industry experience OR MS with over 15+ years of relevant experience.

  • Expertise in a GMP manufacturing environment.

  • Theoretical and practical knowledge of method development and validation principles to ICH and other guidelines.

  • Outstanding Good Documentation Practices (GDP).

  • Exceptional communication and interpersonal skills, ability to work in a dynamic, time-sensitive environment and prioritize work as assigned. 

  • Experience applying QbD principles to analytical method development and optimization, process, and product development.

  • Familiarity and working knowledge with design aspects of DoE software.

  • Previous CDMO experience.

  • Process Validation and Commercialization requirements for finished products.

  • NDA/CMC filing experience.

​​Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact Sofia Furlan on+44 (0) 203 854 7700 or sofia.furlan@mantellassociates.com.