Senior Scientist I, Downstream Purification, PDS&T Toxins
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Job Location:
Irvine, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Job Summary
The Product Development Science and Technology (PDS&T) Toxins group supports manufacturing process characterization process validation regulatory submission and continuous improvement for late-stage and commercial manufacturing of biological toxin products in AbbVie. We have an exciting opportunity for a Senior Scientist I Downstream Purification position based in Irvine CA. The scientist will apply scientific engineering principles modeling and statistical process design/analysis to develop robust toxin manufacturing process hands-on. The candidate must have in-depth knowledge and hands-on experience including but not limited to bioprocess development scale down model qualification protein characterization etc. Excellent communication skills and the ability to work within a multi-disciplinary and cross-functional teamwork environment are essential.
Responsibilities:
- Support late stage and commercial biologics manufacturing technology transfer process validation investigations troubleshooting scale-up and continuous improvement.
- Develop protein recovery and purification process that utilizes clarification chromatography and membrane filtration technologies. Provide deeper understanding of process performance using appropriate experimental and modeling tools.
- Design execute and analyze experiments using a robust scale-down model for process characterization and continued process improvement of commercial biologics products.
- Leverage data science and advanced modeling to build digital platforms for data visualization and analysis.
- Support/ lead new product introduction into the manufacturing area ensuring successful tech transfer scale up and validation for the product.
- Support product investigations and non-conformances. Identify root causes and make scientific recommendations as to the acceptability and quality of affected product lots.
- Author and review relevant CMC sections of submissions and support agency inspections inquiries and audits.
- Represent the PDS&T Toxins group in CMC program teams. Interact effectively with diverse groups within function and maintain strong working relationships with internal global and external collaborators.
Qualifications :
- BS MS or PhD in Chemical Engineering Biochemistry Chemistry or closely related field with typically 10 (BS) 8 (MS) or 0 (PhD) years of postdoc or industry related experience.
- Experience in areas of bioprocess development process characterization modeling validation regulatory submissions and manufacturing support.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent communication writing and presentation skills are required.
- Must have a results-oriented work ethic and a positive can-do attitude with a strong sense of urgency and self-motivated desire to achieve.
- Demonstrated knowledge of GMP and experience providing technical support in a GMP manufacturing environment
- Demonstrated ability to collaborate effectively in a dynamic cross-functional matrix environment
Additional Information :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Laboratory Experience
- Mammalian Cell Culture
- Biochemistry
- Assays
- Protein Purification
- Research Experience
- Next Generation Sequencing
- Research & Development
- cGMP
- Cell Culture
- Molecular Biology
- Flow Cytometry
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
