- 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.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/visioninsurance 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.
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Principal Research Scientist I - Irvine, United States - BioSpace
Description
Job DetailsCompany 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 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 ingood faith it will pay for this role at the time of this posting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay more or less than the posted range. This range may be modified in the future.
AbbVie 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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