Senior Scientist I - ST - Downstream
Senior Scientist I - ST - Downstream
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Job Description
The PDS&T Toxins group supports manufacturing process characterization process validation regulatory submission and continuous improvement for latestage and commercial manufacturing of biological toxins products in AbbVie. We have an exciting opportunity for a Senior Scientist position based in Irvine CA. The scientist will apply scientific engineering principles and statistical process design/analysis to develop robust toxin manufacturing process handson. The candidate must have indepth knowledge and 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 multidisciplinary and crossfunctional teamwork environment are essential.
Responsibilities:
- Support late stage and commercial biologics manufacturing technology transfer process characterization process validation investigations troubleshooting scaleup and continuous improvement.
- Design execute and analyze experiments using a robust scaledown model for continued process improvement of commercial biologics products.
- Identify and implement technical innovations to improve product quality improve yield qualify new material suppliers reduce cost and/or enhance the intellectual property landscape.
- Support CMC life cycle management and postapproval continued process validation for commercial products.
- Support/ lead new product introduction into the manufacturing area ensuring successful tech transfer scale up and validation for the product.
- Support product investigations and nonconformances. 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. Interacts effectively with diverse groups within function and maintains strong working relationships with internal global and external collaborators.
- Responsible for compliance with applicable Corporate and Divisional policies and procedures.
Qualifications :
- Bachelors Degree or equivalent education and typically 10 years of experience Masters Degree or equivalent education and typically 8 years of experience.
- Experience with bioprocess development validation regulatory submissions and manufacturing support.
- Analytical thinker with excellent problemsolving skills and the ability to adapt to changing priorities and deadlines.
- Excellent communication writing and presentation skills are required.
- Must have a resultsoriented work ethic and a positive cando attitude with a strong sense of urgency and selfmotivated desire to achieve.
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 shortterm 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 serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
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Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
