Job Summary
Designs, executes and authors upstream cell culture development, tech transfer, and optimization studies. Conducts pilot scale material generation runs. Partners with other internal PD teams during process tech transfer, and supports GMP manufacturing and related investigation studies. Participates in client calls and face to face meetings with minimum supervision
Job Responsibilities
- Works on bench scale cell culture process development, optimization and process transfer studies with minimum supervision. Conducts pilot-scale experiments for 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 assists in 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.
- Assists with tech transfer to GMP manufacturing, and supports deviations and investigations.
- Serves as upstream cell culture SMEs to participates in client calls and face to face meetings. Provides project plans and updates to clients.
- Authors Upstream 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, MS with 2+ years or BS with 4+ years of experience in a biopharmaceutical or biological contract testing/manufacturing organization.
- Hands-on experience in upstream cell culture process development using bench scale bioreactors, experience with fed-batch operations.
- Experience with pilot scale bioreactor operation is a plus.
- 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)
The anticipated salary range for this position is $66,000 - $ 106,000
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 expertis and company business needs.
