- Lead CMC analytical development with in-depth knowledge of a broad range of analytical assays for biologic products.
- Lead CQA assessment and relevant characterization studies (e.g., forced degradation study, protein structure elucidation, and chromatographic peak identification) for a comprehensive understanding of the product structure-function relationship.
- 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.
- Lead method development, qualification and validation per the ICH guidelines. Ensure the compliance and consistency of method validation practice within the organization.
- Support building analytical laboratory capability for method development, qualification, validation, and testing support.
- Identify and drive continuous improvement initiatives and implement new technologies that will contribute to future business developments and improvements.
- Partner closely and effectively with diverse groups within function and maintain strong working relationships with internal, global, and external collaborators.
- Lead CMC analytical development with in-depth knowledge of a broad range of analytical assays for biologic products
- Lead CQA assessment and relevant characterization studies (e.g., forced degradation study, protein structure elucidation, and chromatographic peak identification) for a comprehensive understanding of the product structure-function relationship.
- 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.
- Lead method development, qualification and validation per the ICH guidelines. Ensure the compliance and consistency of method validation practice within the organization.
- Support building analytical laboratory capability for method development, qualification, validation, and testing support.
- Identify and drive continuous improvement initiatives and implement new technologies that will contribute to future business developments and improvements.
- Partner closely and effectively with diverse groups within function and maintain strong working relationships with internal, global, and external collaborators.
- Assist with training of staff and development of organizational expertise (e.g. method development, qualification, validation, and extended characterization).
- BS, MS, or PhD in Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, Biophysics or closely related field with typically 14+ (BS), 12+ (MS) or 5+ (PhD) years of industry related experience.
- Proven track record in late phase development, commercialization, and life cycle management of biologic products.
- Demonstrated hands-on experience in developing LC-MS, HPLC/UPLC, CE, and icIEF methods for biologic products
- In-depth expertise in biophysical methods for protein characterization, such as AUC, CD, DSC, MFI.
- Experience with analytical method transfer and validation to support late phase and commercial processes.
- Working knowledge and experience 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.
- 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 common business goals.
- Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
- Embraces the ideas of others, nurtures innovation and manages innovation to reality.
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Principal Research Scientist I - Irvine, United States - AbbVie, Inc
Description
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio.
For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.Job Description
The S&T Toxins group within Operations Science & Technology - Biologics organization supports manufacturing, process validation, 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 lead position based in Irvine, CA reporting to the Director, S&T Toxins.
Applicable only to applicants
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