Senior Research Scientist II

Senior Research Scientist II

The successful candidate will be responsible for managing a team responsible for design of functional characterization strategy and execution of in vitro experiments to evaluate antibody-based therapeutics for treatment of various diseases. This individual will work as part of biologics analytical team focusing on biological functional characterization for biologics development projects. The successful candidate should be able to utilize the appropriate protein-protein interaction assay systems to support biologics drug development, structure function studies, and critical quality attribute assessment for early and late stage biological drug candidates.

Specific Responsibilities

• Lead functional characterization activities in support of biologics characterization for antibody therapeutics.
• Engage cross-functionally with discovery teams, biophysical and structural characterization, team to lead the structure function studies and critical quality attribute assessment for early and late stage biologics.
• Work with multi-functional project team to design and execute analytical characterization strategy to support process and formulation development.
• A thorough understanding of extended physico-chemical and functional characterization, function structure relationship, critical quality attributers for protein therapeutics is required.
• The successful candidate will be expected to demonstrate technical leadership to oversee and delegate experimental/project responsibilities as needed, independently champion technology development projects, be involved in new assay evaluation and optimization, define assay platforms, write/review development summary reports and author Regulatory submissions. The candidate should maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage external data and publications and relevant industry benchmarking information to drive experimental design, data analysis and functional/cross-functional strategy development.
• The candidate will lead the development of bioassays based on Biacore, KinEx, cell-imaging technologies, characterize the primary and higher order structure of biologics drug candidates, elucidate structure-function relationship as part of a team to characterize the molecule, degradation pathways and define critical quality attributes in a phase appropriate context. The candidate will also participate in process comparability studies, as required.
• The successful candidate will be responsible for defining controls, analysis parameters as well as identification and implementation to enable rapid process development (glycosylation, size, charge, etc.). The candidate will work with Discovery teams to identify and deploy orthogonal characterization methods to aid in identifying critical quality attributes. Responsible for production and maintenance of all critical custom reagents for all bioassays.
• The candidate will serve as an analytical development representative on CMC sub-teams and direct team members in the initiation and execution of laboratory experimentation, working on a wide range of problems where analysis of situations or data requires evaluation of intangible variables, requiring regular use of ingenuity and creativity
• The applicant should be an effective communicator of ideas, project goals and results to team members across cross-functional roles/departments. Ability to proactively identify issues and develop solutions in a collaborative multidisciplinary environment. This is a highly collaborative environment where willingness and ability to communicate and work effectively with individuals across various project teams is essential.
• Candidates should be self-motivated and organized, familiar with the relevant literature, and enjoy scientific investigation and thinking, proactively identify issues and develop solutions in a collaborative multidisciplinary environment. The applicant is also expected to exercise considerable latitude in determining objectives and approaches to assignments.
• Strong skills to lead, motivate, and develop the people in their group is highly desirable.
  Routinely makes decisions affecting direction of project and for ensuring project timelines are met.
  Makes key insights and decisions to direct project with minimal data if necessary and understands impact of results. Reviews and approves technical reports. Leads presentations in technical review.

Required Skills

• PhD in Biochemistry, Cell and Molecular Biology, or a related scientific discipline with 7+ years of relevant experience in the Pharmaceutical or Biotechnology industry.
• Excellent communication skills (both verbal and technical) and interpersonal skills are required. Must be able to participate in highly effective teams. Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results and provides direction to members of project teams in the initiation and execution of laboratory experimentation. Experience successful leading projects and managing the team members is required.
• Maintains in-depth knowledge of state-of-the art principles and theories, applying such knowledge to the research direction that supports Company interests. Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and research strategy. Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.

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