Principal Scientist I, Downstream Process Development (4866)

Job Title - Principal Scientist l, Downstream Process Development

Job Title - Cranbury NJ

Job 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.

Responsibilites

• 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 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, 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 SMEs to participates in client calls and face to face meetings. Provides project plans and updates to clients.
• Coach junior scientists and staff on process development and design of experiments.
• 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 (i.e. safety, equipment etc.).
• Contributes to the overall operations and to the achievement of departmental goals.
• May be required to assist in other departments or assigned other duties.

Qualifications

• PhD in Life Sciences or related field with 4+ years, MS with 8+ years of experience in a biopharmaceutical or biological contract testing/manufacturing organization.
• Extensive hands-on experience in downstream purification process development and lab scale and pilot scale experimental execution, including chromatography, UFDF, viral inactivation, depth filtration, and viral filtration, etc.
• Experience with different biologics modalities is a plus.
• Experience in project management, Quality by Design concepts, late-stage process development/tech transfer, control strategy is highly desirable.
• Strong oral & 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 take on multiple tasks simultaneously.
• Proficient in Microsoft (Excel, Word, Outlook)
• Must be able to work in Lab setting with Biohazards /various Chemicals
• Must be able to wear appropriate PPEs
• Ability to Lift 40 lbs

The anticipated base salary range for this position is $90k - $140k

The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.