Senior Analytical Scientist
- Employer
- Xeris Biopharma, Inc.
- Location
- Chicago, Illinois
- Start date
- Jan 14, 2021
View more
- Discipline
- Quality, Quality Control, Regulatory, Regulatory Affairs, Science/R&D, Bioengineering, Biology, Chemistry, CMC
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
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
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