Principal Research Scientist I -( On-site Irvine, CA)
Principal Research Scientist I -( On-site Irvine, CA)
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Job Description
The Toxins group within the Product Development Science & Technology (PDS&T) - Biologics organization supports manufacturing regulatory submission and continuous improvement for late-stage and commercial manufacturing of biological toxins products at AbbVie. We have an exciting opportunity for a group leader position based in Irvine CA reporting to the Director of PDS&T Toxins. The Toxins group within the Product Development Science & Technology (PDS&T) - Biologics organization supports manufacturing regulatory submission and continuous improvement for late-stage and commercial manufacturing of biological toxins products at AbbVie. We have an exciting opportunity for a group leader position based in Irvine CA reporting to the Director of PDS&T Toxins.
- Lead team in analytical assay transfer development optimization and validation for biological toxin products following ICH guidelines. Focus areas include HPLC CE iCIEF ELISA and qPCR. Ensure compliance and consistency of method validation practice within the organization.
- Provide analytical support for troubleshooting in GMP manufacturing and QC testing.
- Provide analytical support for process development and improvement process characterization and validation.
- Manage laboratory operations to ensure lab safety and compliance with EH&S requirements.
- Support building analytical laboratory capability for method development validation and testing support.
- Author and review CMC analytical sections of BLA and other CMC regulatory packages such as analytical methods specifications analytical comparability and elucidation of structure and stability assessment. Develop strategies for addressing health authority inquiries. Provide technical leadership for agency inspections inquiries and audits.
- Communicate and present analytical development topics in cross-functional CMC meetings.
- Identify and drive continuous improvement initiatives and implement new technologies that will contribute to future analytical improvements.
- Partner closely and effectively with diverse groups within function and maintain strong working relationships with internal global and external collaborators.
Qualifications :
- BS MS or PhD in Biochemistry Analytical Chemistry Pharmaceutical Sciences or closely related field with typically 14 (BS) 12 (MS) or 5 (PhD) years of industry related experience.
- Ability to work with select agents in accordance with all relevant safety and compliance regulations
- Must have a results-oriented work ethic and a positive can-do attitude with a strong sense of urgency self-motivated and the ability to lead a team to achieve common business goals.
- Proven track record in late phase and commercial assay development and validation and life cycle management of biologic products.
- Demonstrated hands-on experience in developing HPLC/UPLC CE ELISA qPCR and icIEF methods for biological products
- Demonstrated extensive experience in assay validation in accordance with ICH guideline.
- Extensive experience in analytical method transfer and supporting QC troubleshooting.
- Extensive knowledge and experience working in a cGMP environment
- Excellent interpersonal and oral/written communication skills and advanced technical writing for submissions. Extensive experience in regulatory filing and addressing health authority questions.
- Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
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.
This job is eligible to participate in our long-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
Employment Type
Full-time
