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WuXi Biologics

Scientist II, Downstream Process Development

WuXi Biologics, Cranbury, New Jersey, United States

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Overview Job Title : Associate Scientist, Downstream Process Development

Base pay range : $50,000.00/yr - $75,000.00/yr

Work Location : Cranbury, NJ

Summary Designs, executes and authors downstream purification development, optimization, scale up and tech transfer. Collaborates with other internal PD teams during process development and tech transfer. Supports pilot production, GMP manufacturing and related investigation studies. Serves as SME in client calls and face to face 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 on time delivery: from initial planning, experiment execution, to data evaluation.

Performs independent data analysis and interpretation, and develops strategies for optimization and troubleshooting.

Authors study protocols and reports, and ensures all 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.

Serves as downstream purification SME, participates in client calls and face-to-face meetings. Provides project plans and updates to clients.

Authors downstream lab equipment SOPs; maintains equipment functionality and coordinates repairs and preventative maintenance.

Performs job-specific tasks in compliance with applicable Regulations, International Standards, and WuXi Biologics internal policies and guidelines.

Completes all required training (e.g., safety, equipment).

Contributes to overall operations and to the achievement of departmental goals.

May be required to assist in other departments or perform other duties as assigned.

Qualifications

PhD in Life Sciences or related field, MS with 2+ years or BS with 4+ years of experience in a biopharmaceutical or biological contract testing/manufacturing organization.

Extensive hands-on experience in downstream purification process development and lab-scale execution, including chromatography, UFDF, TFF, viral inactivation and filtration.

Strong oral and written communication skills are required.

Ability to work effectively as part of a team and to exhibit effective interpersonal skills.

Experience in a cGMP environment is highly desirable.

Ability to manage multiple tasks simultaneously.

Proficient in Microsoft Excel, Word, Outlook.

Other

Seniority level: Mid-Senior level

Employment type: Contract

Job function: Research, Analyst, and Information Technology

Industries: Pharmaceutical Manufacturing

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