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Scientist, Vaccines and Advanced Biotechnologies (VAX) Process R&D

External
Merck logoMerck · - Pennsylvania - West Point
Full-timeOn-site1w ago
LeadershipSAFe
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Job Description Vaccines and Advanced Biotechnologies (VAX) Process R&D is responsible for the development and clinical manufacturing of Drug Substance (DS) and Drug Product Intermediates (DPI) for the vaccine and advanced therapy pipeline, spanning from preclinical to commercialization stages. We are part of the Process R&D organization, which enables modality-agnostic DS/DPI process development and clinical manufacturing for our company's pipeline. Our vaccines downstream process development team develops safe, scalable, robust, cost-effective downstream processes that enable clinical and commercial manufacture of vaccines and adjuvants across all vaccine modalities. We are seeking an innovative, highly motivated, and experienced Scientist to join us at our research and development site in West Point, PA. The candidate will be responsible for scientific/technical contributions and leadership of bioconjugation process development, and will also be a critical member of cross-functional program/project teams. This role will require frequent collaboration with cross-functional teams including Analytical, Formulation, Process Chemistry, Enabling Technologies, and Manufacturing colleagues. The candidate should have a strong background in downstream bioprocess/bioconjugation design, including reaction steps, filtration (tangential and normal flow) and column chromatography. Primary responsibilities include, but are not limited to : Independent design, execute, and analyze process development experiments to maximize conjugate vaccine production processes, thereby de-risking later stage development and tech transfer. Leadership roles in downstream process design and development for conjugate vaccine candidates. Represent functional area in cross-functional and strategic teams engaged in vaccine development. Lead tech transfer of vaccine drug substance processes for clinical and commercial manufacture. Serve as a scientific/technical mentor. Provide technical guidance in the various aspects of downstream bioprocess/bioconjugation development. Support strategic initiatives and innovation in the areas of vaccine and advanced biotechnology process development. Analysis of experiments through analytical techniques including HPLC, light scattering, and spectroscopy. Data interpretation and presentation, manuscript/patent preparation. Education Minimum Requirement : BS, MS or PhD in engineering or bio/chemical sciences: Chemical Engineering, Bioengineering, Biomedical Engineering, Chemistry, Biochemistry, Molecular Biology, Biotechnology For BS candidates, at least two (2) years of experience in a pharmaceutical or biotechnology-related position For MS candidates, at least one (1) year of post-graduate experience in bioprocess/biotechnology-related position (vaccines and/or therapeutic proteins) or relevant academic research thesis. Required Experience and Skill s: Must have scientific understanding of downstream bioprocess purification processes. Scientific understanding of purification operations of large complex molecules. Technical understanding of bioprocess scaling principles. Prior hands-on bioprocess development experience through academic lab or industry experience. Position requires employee to be willing to work with infectious agents and/or pathogens. Position requires occasional travel and off hour/weekend work. Strong scientific and hands-on understanding of downstream bioprocess/bioconjugation unit operations, biotherapeutic and/or vaccine process development and sound understanding of scale-up principles. Ability to work effectively both independently and in a team-focused environment. Preferred Experience and Skills : Prior hands-on experience with any of the following purification bioprocesses: Tangential Flow Filtration, Dead-End Filtration, Chromatography, or Homogenization. Experience in Process Tech Transfer to production facilities. Experience with biomolecule conjugation (e.g., conjugate vaccines, antibody-drug conjugates), conjugation chemistry and downstream bioconjugate processing. Strong understanding of, or hands-on experience in, cGMP manufacturing. The successful candidate will be expected to demonstrate the ability to communicate results of their work in both verbal and written formats. They are also expected to demonstrate flexibility in responding to changing priorities or dealing with unexpected events. In addition to the core responsibilities outlined above, the candidate will be expected to comply with all required training and maintain a focused attention on laboratory safety for themselves and their team. Position may require working with infectious agents, pathogens, and/or potent compounds with appropriate engineering controls and PPE. Some travel or off-hours work may be required. #PRD Required Skills: Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed


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