Sr Research Scientist I, Analytical Operations
Essential Duties and Job Functions:
- Manages a group of scientists that perform protein structure and characterization studies
- Leads analytical method development projects and qualification for protein and structure characterization activities.
- Demonstrates technical proficiency, scientific creativity and independent thought in experimental design and strategy.
- Manage projects in executing project plans and coordinates with team to characterize molecules, degradation pathways, and define critical quality attributes.
- Defines, conducts, and instructs group in comparability studies.
- Advises and manages analysis of in-process samples and product related impurities as needed.
- Works in a matrixed environment and effectively communicate of ideas, results, and problems.
- Conceives and optimizes experiments and proactively troubleshoots problems.
- Identifies areas for improvement and efficiency gains.
- Leads method transfers to QC and external CRO/CMO laboratories.
- Maintains full working knowledge scientific literature for techniques and instruments and applying appropriately to projects.
- Represents the company at national/international conferences.
- Manages multiple projects and ensures analytical deliverables are met within timelines.
- Responsible for conducting scientific research for the development of drug candidates.
- Works on moderately complex problems where analysis of situations or data requires evaluation of intangible variables, requiring regular use of intelligence, logic, ingenuity, and creativity.
- Initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.
- Presents results of work, interprets data, and draws conclusions within the context of the work.
- Experience with Regulatory Filings and authoring relevant sections is desired.
- Works under supervision of scientific directors to analyze laboratory. experimentation and advance the development of state-of-the-art techniques to characterize drug product formulations and processes.
- The applicant is also expected to exercise considerable latitude thus thinking critically and creatively to determine appropriate resources for resolution of problems. Therefore, the candidate must have strong organizational and planning skills.
- Maintains full working knowledge of principles and theories, applying such knowledge to the direction that supports company interests.
- Demonstrates ability in developing methods, techniques, and evaluation criteria for obtaining results and interpreting experimental outcomes.
- Provides expertise and advises for troubleshooting issues with assays in QC, Technical Services, and manufacturing.
- Draft and revise standard operating procedures for analytical methods.
- Interacts with Process Sciences, Manufacturing Sciences & Technology, Quality Control, Project Management Office.
- Acts a mentor and technical trainer for staff to junior staff.
Required Education, Knowledge & Skills
- PhD in life sciences or engineering with 3+ years of experience in biotechnology or pharmaceutical development
- Significant knowledge of analytical methods used in biopharmaceutical development including mass spectrometry.
- Extensive experience in operating mass spectrometers and processing related data (i.e. peptide mapping, intact analysis).
- Has independently or as project management, led the development of new assays and transferred them to GMP environment.
- Strong understanding of pharmaceutical product development and experience working with monoclonal antibody or ADC products.
- Must possess excellent communication (oral and written), organizational, and interpersonal skills, with the ability to lead a high-performing team. People managing experience preferred.
- Familiarity with GLP/GMP practices and regulations. Experience working in a regulated environment is preferred.
- Has experience in leading project teams and mentoring of junior scientists.
- Must be proficient with MS Office applications. Working knowledge of LIMS systems preferred.
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