WuXi Biologics
Principal Scientist I, Downstream Process Development
WuXi Biologics, Cranbury, New Jersey, United States
Overview
Job title - Principal Scientist I, Downstream Process Development. Work location - Cranbury, NJ. WuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. We employ a large team and provide opportunities across the globe. This description reflects the Principal Scientist I, Downstream Process Development role. Role summary: Designs, executes, and authors downstream purification development, optimization, scale-up and tech transfer. Collaborates with other internal Process Development teams during process development and tech transfer. Supports pilot production, GMP manufacturing and related investigations. Serves as a subject-matter expert in client calls and meetings. Responsibilities
Responsible for bench-scale purification process development, optimization, and process transfer studies. Designs and executes pilot-scale experiments to support non-GMP material generation. Manages project workflow to ensure timely delivery: from initial planning, experiment execution, to data evaluation. Performs independent data analysis, interpretation, and develops strategies for optimization and troubleshooting. Authors study protocols and reports, ensures data are reported clearly and accurately; serves as trainer for inter- and intradepartmental staff as needed. Leads tech transfer to GMP manufacturing and supports deviations and investigations. Participates as Downstream purification SME in client calls and meetings; provides project plans and updates to clients. Coaches junior scientists and staff on process development and design of experiments. Authors Downstream lab equipment SOPs; maintains equipment functionality and coordinates repairs and preventive maintenance. Performs job-specific tasks in compliance with applicable regulations, international standards, and WuXi Biologics policies and guidelines. Completes all required training (e.g., safety, equipment). Contributes to overall operations and achievement of departmental goals. May be required to assist in other departments or assume other duties as needed. Qualifications
PhD in Life Sciences or related field with 4+ years of experience; MS with 8+ years in a biopharmaceutical or biological contract testing/manufacturing organization. Extensive hands-on experience in downstream purification process development and lab/pilot-scale experimental execution, including chromatography, UFDF, viral inactivation, depth filtration, and viral filtration. Experience with different biologics modalities is a plus. Experience in project management, Quality by Design concepts, late-stage process development/tech transfer, and control strategy is highly desirable. Strong oral and written communication skills. Ability to work effectively as part of a team and to exhibit interpersonal skills. Experience in a cGMP environment is highly desirable. Ability to manage multiple tasks concurrently. Proficient in Microsoft Excel, Word, and Outlook. Physical requirements
Must be able to work in a lab setting with biohazards and various chemicals. Must be able to wear appropriate PPE. Ability to lift up to 40 lbs. Compensation
The anticipated pay for this position is $85,000 - $137,000. Equal Opportunity
WuXi Biologics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Notes
The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position may be required to perform other job-related duties/responsibilities based on their expertise and the company’s business needs.
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Job title - Principal Scientist I, Downstream Process Development. Work location - Cranbury, NJ. WuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. We employ a large team and provide opportunities across the globe. This description reflects the Principal Scientist I, Downstream Process Development role. Role summary: Designs, executes, and authors downstream purification development, optimization, scale-up and tech transfer. Collaborates with other internal Process Development teams during process development and tech transfer. Supports pilot production, GMP manufacturing and related investigations. Serves as a subject-matter expert in client calls and meetings. Responsibilities
Responsible for bench-scale purification process development, optimization, and process transfer studies. Designs and executes pilot-scale experiments to support non-GMP material generation. Manages project workflow to ensure timely delivery: from initial planning, experiment execution, to data evaluation. Performs independent data analysis, interpretation, and develops strategies for optimization and troubleshooting. Authors study protocols and reports, ensures data are reported clearly and accurately; serves as trainer for inter- and intradepartmental staff as needed. Leads tech transfer to GMP manufacturing and supports deviations and investigations. Participates as Downstream purification SME in client calls and meetings; provides project plans and updates to clients. Coaches junior scientists and staff on process development and design of experiments. Authors Downstream lab equipment SOPs; maintains equipment functionality and coordinates repairs and preventive maintenance. Performs job-specific tasks in compliance with applicable regulations, international standards, and WuXi Biologics policies and guidelines. Completes all required training (e.g., safety, equipment). Contributes to overall operations and achievement of departmental goals. May be required to assist in other departments or assume other duties as needed. Qualifications
PhD in Life Sciences or related field with 4+ years of experience; MS with 8+ years in a biopharmaceutical or biological contract testing/manufacturing organization. Extensive hands-on experience in downstream purification process development and lab/pilot-scale experimental execution, including chromatography, UFDF, viral inactivation, depth filtration, and viral filtration. Experience with different biologics modalities is a plus. Experience in project management, Quality by Design concepts, late-stage process development/tech transfer, and control strategy is highly desirable. Strong oral and written communication skills. Ability to work effectively as part of a team and to exhibit interpersonal skills. Experience in a cGMP environment is highly desirable. Ability to manage multiple tasks concurrently. Proficient in Microsoft Excel, Word, and Outlook. Physical requirements
Must be able to work in a lab setting with biohazards and various chemicals. Must be able to wear appropriate PPE. Ability to lift up to 40 lbs. Compensation
The anticipated pay for this position is $85,000 - $137,000. Equal Opportunity
WuXi Biologics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Notes
The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position may be required to perform other job-related duties/responsibilities based on their expertise and the company’s business needs.
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