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Assignment: Subvisible Particle Analysis Coordinator, Biophysical Characterization
Job Level/Title: Senior Research Associate (Level 7)
Searching for a highly-proficient analytical project coordinator to contribute to its subvisible particulate (SVP) analysis efforts in the Biophysical Characterization group of its Protein Pharmaceutical Development department. This individual will coordinate and oversee the development and deployment of SVP methods in our in-house laboratories and at external analytical contract laboratories. Working with internal stakeholders and external laboratories, this person will be responsible for executing studies, managing timelines, writing high-quality documents, and delivering information in support of both pipeline programs and commercial product lifecycle management initiatives.
Responsibilities include:
Coordinating SVP activities between internal laboratory staff and external contract laboratories.
Facilitating the development and transfer of SVP methods for analysis of biopharmaceutical drug product solutions: light obscuration (HIAC), flow-imaging microscopy (MFI), and dynamic light scattering; of these, MFI methods will be of greatest emphasis;
Collaborating with internal project teams and external contract laboratories to identify method needs and demands (i.e., sample workload, scheduling);
Ensuring timely acquisition and reviews of SVP data to support process development, tech transfer, and manufacture of biopharmaceuticals at all stages throughout the Biogen Idec product portfolio/pipeline;
Authoring/reviewing necessary SOPs, and preparing final reports/documentation in support of method training and regulatory submissions.
Qualifications:
Experience in managing method development and transfers of biopharmaceutical product quality assays to contract analytical laboratories is essential. Specific experience with the transfer of flow-imaging microscopy methods (FlowCAM, ProteinSimple MFI) is preferred, but not required;
Proven skills in time management, budget tracking, project management, and ability to manage several projects simultaneously are critical for success in this assignment;
Excellent written and oral communication skills; strong technical writing skills (SOPs, development reports) are required;
Prior knowledge and/or hands-on experience in SVP analysis principles and method development is beneficial. Methods may include light obscuration, flow-imaging microscopy, and/or other related methods;
Prior experience working in a biopharmaceutical product development environment and familiarity with GMPs and FDA/ICH guidelines is preferred.
Education:
Interested candidates must have a B.S. in Chemistry, Biochemistry, Biology, or related discipline with at least 6 years of relevant work experience in biotechnology; a M.S. degree with a minimum of 4 years of relevant work experience; or a Ph.D. in Chemistry or related discipline with 0-2 years of experience.