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Formulation Scientist

Chicago, IL

Posted: 01/21/2021 Employment Type: Direct Hire Job Category: Clinical: Scientific Job Number: 2630

Job Description

The Formulation Scientist will provide technical leadership for the development of pre-clinical and early clinical stage candidates using our Client’ s proprietary technology for the delivery of small molecule and peptide/protein therapeutic agents. The successful candidate will be expected to drive programs from inception through preclinical manufacture/screening, technology transfer to selected CDMOs, early cGMP manufacture working closely with Quality and CMC counterparts as well as any necessary analytical method development, specification development, and assessment of stability data/programs.

Essential Job Functions:
  • Develop and refine client’ s proprietary technology platform (sterile suspension/paste in oil), including formulation, process and scaleup.
  • Develop robust phase appropriate preclinical formulations to screen commercial opportunities
  • Prepare and supply finished drug product (non-GLP, GLP) for internal and external studies
  • Conduct formulation optimization through Design of Experiments
  • Oversee the development of analytical methods to support the formulation development activities and early phase specifications for pre-clinical and clinical supplies.
  • Design stability studies, analyze and summarize analytical data, contribute to storage condition recommendations and product expiry/shelf life
  • Contribute to the identification/qualification of sterile fill-finish CDMOs and facilitate technology transfer activities for non-GMP and cGMP drug product manufacture
  • CDMO management for early phase CTM manufacture
  • Write, review and approve technical protocols and reports
  • Write, review and edit appropriate sections of Regulatory submissions
  • Represent Product Development at cross functional Core Team interactions
  • Perform other duties as required
  • Up to 25% travel required

Skills and Qualifications
  • Ph.D. in Chemistry or related scientific field with a minimum of 9 years of experience working within formulation development, analytical method development and CMC
  • Experience with the development of sterile parenteral products
  • Experience in particle engineering and sterile suspension and paste manufacturing preferred.
  • Demonstrated experience in preclinical and early clinical development
  • Solid understanding of GLP and GMP regulations with a working understanding of ICH and FDA guidelines
  • Experience managing CDMO’ s at all stages of development
  • Working understanding of analytical method development activities, HPLC/UPLC experience, experience using compendial methods for the characterization of parenteral products
  • Direct experience with the development of early phase clinical CTM specifications
  • Experience writing NDA, IND and other regulatory submissions
  • Preferred Combination product experience
  • Solid written and oral presentation skills
  • Communicates clearly and effectively across multiple functions and levels to foster a friendly collaborative work environment
  • Excellent problem-solving skills
  • Ability to be flexible and thrive in a fast-paced environment
  • Proactive team player who can also work independently

Meet Your Recruiter

Aaron Goldman
Principal Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past nine years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!

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