Senior Analytical Scientist

Overview

The Sr. 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.

Responsibilities

• 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.

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