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Analytical Scientist

Chicago, IL

Posted: 01/21/2021 Employment Type: Direct Hire Job Category: Clinical: Scientific Job Number: 2640

Job Description

The Analytical Scientist will provide technical leadership for the development and registration of the company’ s pipeline of preclinical- and clinical development-stage candidates. This role defines and executes the overall analytical strategy for biopharmaceuticals, including leading the effort in managing and overseeing analytical method development, method qualification and transfer, and biophysical/biochemical characterization activities for recombinant antibodies and related biologic modalities. Provides leadership in developing a comprehensive analytical characterization strategy for biologics assets from pre-clinical through clinical development and commercial.

Essential Job Functions:
  • Define and execute overall strategy for biopharmaceutical analytical development.
  • Establish the Biopharmaceutical analytical core functional capabilities which includes resource planning, recruiting top talent, and setting up internal labs.
  • Lead and manage the evolution of a phase-appropriate strategy for method development, qualification and transfer for drug substance and drug product.
  • Support and manage activities performed at API suppliers and CROs/CDMOs associated with method development and validation, stability assessment, and release testing of drug substance, drug product and reference standards.
  • Establish product-specific QC release/stability assays, provide biochemical and biophysical analytical support for drug product characterization and manufacturing, and prepare comparability assessments associated with changes in manufacturing process, scale and/or site.
  • Lead the development and maturation of specifications for drug substance and drug product in agreement with evolving control strategies in a dynamic developmental environment.
  • Collaborate with regulatory-CMC in defining technical content, related to analytical sections, of module 3 for IND and NDA/BLA submission.
  • Co-author and review technical content of analytical sections in IND and NDA/BLA and ensure timelines are met.
  • Co-author and review responses to regulatory inquiry regarding IND, NDA, and BLA submissions.
  • Select, manage and audit CRO/CDMO.
  • Establish and implement processes to enable effective collaboration with CRO/CDMO business partners to ensure efficiency and high quality of results.
  • Identify and establish relationships with external consultants/subject matter experts to leverage knowledge and experience not available in-house.
  • Partner with Quality Assurance and Regulatory Affairs-CMC to ensure completion of appropriate documentation and maintenance of high-quality standards.
  • Partner with Quality Control group to transfer and support analytical program in support of commercial track development programs.

Requirements / Qualifications:
  • Ph.D. in chemistry, biology, biochemistry, or biochemical/bioprocess engineering or related technical discipline.
  • Minimum of 9 years of small molecule, peptides and biopharmaceutical analytical experience and exposure to all stages of biopharmaceutical development.
  • Demonstrated track record of leading and managing biophysical/biochemical characterization of biological products, analytical methods development, CRO/CDMO management, and qualification and transfer activities.
  • Strong knowledge of CMC analytical and regulatory requirements, including establishment of product specifications, governing biologics product development.
  • Hands-on working experience in IND, NDA/BLA authoring, submission and approval.
  • Competencies: Strategic & Functional Leadership, Collaboration, Project Management, Adaptability, Problem Solving, Self-Motivated, Technical Writing and Presentation skills, Written and Verbal Communication skills, Professionalism

Meet Your Recruiter

Tracey Goldthwaite
Senior Vice President

Tracey spearheads the firm’s Commercial practice and focuses on identifying and placing individuals in leadership roles within Global Marketing, Medical Affairs, New Product Planning, and Patient Advocacy and Engagement, to name a few. With 25 years of experience, she also plays a key role in the Clinical Staffing practice, recruiting top talent of all levels for positions in our core areas including Clinical Operations and Development, Regulatory Affairs, Pharmacovigilance and Program Management.

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