Senior Scientist, II
AbbVie
18 days ago
On-site
Irvine, CA
$109,500 - $208,500 USD yearly
Clinical Research and Development
Responsibilities:
- Support late-stage and commercial biologics manufacturing, technology transfer, process validation, investigations, troubleshooting, scale-up, and continuous improvement.
- Develop protein recovery and purification processes using clarification, chromatography, and membrane filtration; use experimental and modeling tools to deepen understanding of process performance.
- Design, execute, and analyze experiments using a robust scale-down model for process characterization and continued process improvement.
- Leverage data science and advanced mechanistic modeling to build digital platforms for data visualization, analysis, and prediction.
- Support/lead new product introduction into manufacturing, ensuring successful tech transfer, scale-up, and validation.
- Support product investigations and non-conformances; identify root causes and make scientific recommendations on acceptability and quality of affected lots.
- Author and review relevant CMC sections of submissions; support agency inspections, inquiries, and audits.
- Represent the PDS&T Toxins group in CMC program teams and collaborate with internal, global, and external stakeholders.
Qualifications:
- BS, MS, or PhD in Chemical Engineering, Biochemistry, Chemistry, or closely related field; typically 12+ (BS), 10+ (MS), or 4+ (PhD) years of postdoc or industry experience.
- Experience in bioprocess development, process characterization, modeling, validation, regulatory submissions, and manufacturing support.
- Demonstrate independence leadership and an enterprise mindset.
- Analytical thinker with excellent problem-solving skills; able to adapt to changing priorities and deadlines.
- Excellent communication, writing, and presentation skills.
- Results-oriented work ethic with urgency and a self-motivated “can-do” attitude.
- Demonstrated GMP knowledge and technical support experience in GMP manufacturing.
- Ability to collaborate in a dynamic cross-functional matrix environment.
- Support late-stage and commercial biologics manufacturing, technology transfer, process validation, investigations, troubleshooting, scale-up, and continuous improvement.
- Develop protein recovery and purification processes using clarification, chromatography, and membrane filtration; use experimental and modeling tools to deepen understanding of process performance.
- Design, execute, and analyze experiments using a robust scale-down model for process characterization and continued process improvement.
- Leverage data science and advanced mechanistic modeling to build digital platforms for data visualization, analysis, and prediction.
- Support/lead new product introduction into manufacturing, ensuring successful tech transfer, scale-up, and validation.
- Support product investigations and non-conformances; identify root causes and make scientific recommendations on acceptability and quality of affected lots.
- Author and review relevant CMC sections of submissions; support agency inspections, inquiries, and audits.
- Represent the PDS&T Toxins group in CMC program teams and collaborate with internal, global, and external stakeholders.
Qualifications:
- BS, MS, or PhD in Chemical Engineering, Biochemistry, Chemistry, or closely related field; typically 12+ (BS), 10+ (MS), or 4+ (PhD) years of postdoc or industry experience.
- Experience in bioprocess development, process characterization, modeling, validation, regulatory submissions, and manufacturing support.
- Demonstrate independence leadership and an enterprise mindset.
- Analytical thinker with excellent problem-solving skills; able to adapt to changing priorities and deadlines.
- Excellent communication, writing, and presentation skills.
- Results-oriented work ethic with urgency and a self-motivated “can-do” attitude.
- Demonstrated GMP knowledge and technical support experience in GMP manufacturing.
- Ability to collaborate in a dynamic cross-functional matrix environment.