Scientist, Engineering

Position Description: The Bioprocess Drug Substance and Commercialization (BDSC) group within our Manufacturing Division focuses on late-stage process development, technology transfer, and in-line support of biologics. We seek a motivated scientist/engineer to work under technical direction of a group leader to support development and licensure. In this role, you will be responsible for:

Leading the hands-on execution of experiments in biologics downstream processing, including lab-scale process characterization, pilot-scale process development, and process scale-up/scale-down model development Collaborating with commercial manufacturing teams as a process sciences representative to support facility start-up and in-line support activities, including on-the-floor support for drug substance manufacturing as needed Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ) and licensure Position Qualifications:

Minimum Requirement: Bachelor’s Degree or higher in Chemical Engineering, Chemistry, Biology or comparable discipline with 3+ years of experience. Required Experience and Skills: Significant experience with downstream processing of monoclonal antibody (mAb) products or similar products in a laboratory or manufacturing setting, including unit operations such as membrane filtration, preparative chromatography, ultrafiltration or tangential flow filtration, and viral clearance unit operations Mechanistic understanding of downstream processing separation sciences Ability to understand and execute experiments independently in a manner that meets quality and timeline expectations Well-developed communication, organizational, and problem-solving skills, with an attention to detail Preferred Experience and Skills: Large molecule drug substance technology transfer Collaboration with analytical teams, pilot-scale, and/or manufacturing environment Experience authoring technical documentation in support of the following: process description, process characterization, process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions. Current Good Manufacturing Practice (cGMP) awareness or experience Required Skills: Biopharmaceuticals, Biopharmaceuticals, Biopharmaceutics, Cell Culture Techniques, cGMP Regulations, Chemical Engineering, Chemical Technology, Clinical Manufacturing, Data Analysis, Detail-Oriented, Downstream Process Development, Downstream Processing, Experimentation, Good Manufacturing Practices (GMP), Interdisciplinary Collaboration, Maintenance Supervision, Monoclonal Antibodies, Pharmaceutical Biology, Pharmaceutical Process Development, Polyclonal Antibody Production, Product Formulation, Production Process Development, Risk Control Assessment, Technical Writing, Technical Writing Documentation {+ 2 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S.

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