Senior Scientist, I- Analytical Development ( On-site-Worcester, MA)

AbbVie Inc; Worcester (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading company in the biopharmaceutical industry is seeking a Senior Scientist I to join their Analytical Development team. The role involves developing and qualifying analytical methods for biologics, ensuring compliance with health authority standards, and collaborating with cross-functional teams. Ideal candidates will have a strong background in method development and a proven ability to lead complex projects. This position offers a chance to make a significant impact on product quality and regulatory success.

Qualifications

• 10+ years with Bachelor's, 8+ years with Master's, or PhD with no experience.
• Experience in method development and validation for biological products.

Responsibilities

• Partner with Analytical Development for commercial method readiness.
• Oversee analytical method transfer and troubleshooting.
• Prepare technical documents for global compliance.

Skills

ELISA

qPCR

problem-solving

critical thinking

Education

Bachelor’s Degree

Master’s Degree

PhD

Tools

western blot

ddPCR

SPR

automation

Job 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 www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and TikTok.

Job Description

We are seeking a highly motivated Senior Scientist I to join our Analytical Development team in the Product Development Science and Technology, Biologics Development Launch division. Our team is responsible for developing, qualifying, and executing analytical methods to provide product and process understanding for biological entities from discovery through commercial stages.

The successful candidate will be part of the Biomolecular Interaction Group, focusing on method development and implementation of immunoassays to monitor process impurities and assess potency of AbbVie's biologics. Techniques include ELISAs for impurity monitoring, surface plasmon resonance using Biacore for antigen and Fc receptor binding assessments, and qPCR for residual DNA and mycoplasma detection. The role involves managing all analytical aspects of biologics products on the market, overseeing methods throughout their lifecycle, establishing product specifications, stability programs, and regulatory filings. Collaboration with analytical teams, process development, global QC, and manufacturing is essential to meet business milestones.

Responsibilities:

• Partner with Analytical Development groups to achieve commercial method readiness using techniques like ELISA, bioassays, spectrophotometry, and compendial methods.
• Participate in cross-functional, multi-site, global meetings/projects; oversee analytical method transfer, investigations, performance monitoring, and troubleshooting.
• Establish analytical lifecycle strategies including methods, stability, specifications, and change management aligned with health authority standards.
• Prepare and review technical documents for global compliance, including validation protocols, reports, and reference standard qualification.
• Support regulatory submissions, inspections, and respond to agency deficiency letters.
• Review and update methods periodically; design and execute remediation experiments as needed.

Qualifications:

• Bachelor’s Degree with 10+ years of experience, Master’s Degree with 8+ years, or PhD with no experience necessary.
• Experience in method development, qualification, validation, and transfer for biological products.
• Skills in ELISA, western blot, qPCR, ddPCR, SPR, and automation.
• Ability to lead projects and manage teams of significant scope and complexity.
• Strong critical thinking, troubleshooting, and problem-solving skills.

Additional Information

Details about compensation, benefits, and legal disclosures are provided, including information about pay ranges, benefits, and equal opportunity employment policies.