Principal Research Scientist I -( On-site Irvine, CA)

Allergan; Irvine (CA); On-site; USD 121,000 - 230,000; Full time

Job summary

A leading company in the biopharmaceutical sector is seeking a Principal Research Scientist I to lead analytical assay development and validation for biological products. This on-site role in Irvine, CA involves managing a team, ensuring compliance with regulatory requirements, and collaborating with internal and external partners. Ideal candidates will possess a strong background in analytical chemistry and significant industry experience, alongside excellent communication skills to navigate regulatory landscapes.

Qualifications

• 14+ years (BS), 12+ years (MS), or 5+ years (PhD) of industry experience required.
• Proven track record in validation and lifecycle management of biologics sought.
• Excellent communication skills essential for regulatory filings.

Responsibilities

• Lead analytical assay transfer, development, and validation for biological products.
• Provide analytical support for GMP manufacturing and QC testing.
• Author and review CMC analytical sections for regulatory submissions.

Skills

Analytical method transfer

Assay development

Team leadership

Communication skills

Results-oriented

Education

BS, MS, or PhD in Biochemistry

Pharmaceutical Sciences

Tools

HPLC

ELISA

qPCR

CE

icIEF

Job description

Principal Research Scientist I -( On-site Irvine, CA)

• Full-time
• Salary Min: 121000
• Salary Max: 230000

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 www.abbvie.com. Follow us on Twitter, Facebook, Instagram, YouTube, and LinkedIn.

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.

Responsibilities:

1. 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.
2. Provide analytical support for troubleshooting in GMP manufacturing and QC testing.
3. Support process development, improvement, characterization, and validation.
4. Manage laboratory operations to ensure safety and compliance with EH&S requirements.
5. Support building analytical laboratory capabilities for method development, validation, and testing.
6. Author and review CMC analytical sections of regulatory submissions, including analytical methods, specifications, comparability, structure elucidation, and stability assessments. Develop strategies for addressing health authority inquiries and support agency inspections, inquiries, and audits.
7. Communicate and present analytical development topics in cross-functional meetings.
8. Identify and implement continuous improvement initiatives and new technologies.
9. Collaborate effectively with internal and external partners.

Qualifications:

• BS, MS, or PhD in Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field with 14+ (BS), 12+ (MS), or 5+ (PhD) years of industry experience.
• Ability to work with select agents in compliance with safety regulations.
• Results-oriented with a positive attitude, self-motivated, and capable of leading a team.
• Proven track record in assay development, validation, and lifecycle management of biologics.
• Hands-on experience with HPLC/UPLC, CE, ELISA, qPCR, and icIEF methods.
• Extensive experience in assay validation per ICH guidelines.
• Experience in analytical method transfer and troubleshooting.
• Knowledge of cGMP environment.
• Excellent communication skills and experience with regulatory filings.

Additional information on compensation, benefits, and equal opportunity employment policies is available in the original description.