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

BioSpace; Worcester (MA); On-site; USD 80,000 - 120,000; Full time

Job summary

A leading company in biopharmaceuticals is seeking a Senior Scientist I for its Analytical Development team in Worcester, MA. The successful candidate will focus on developing and qualifying analytical methods for biological products, ensuring compliance with health authority standards. This role involves collaboration across teams to support the lifecycle of biologics, making it crucial for the company's mission to deliver innovative medicines.

Benefits

Health insurance

401(k)

Paid time off

Incentive programs

Qualifications

• 10 years experience with Bachelor's, 8 years with Master's, or PhD with no experience.
• Industry experience in method development and validation for biological products.
• Proven ability to lead projects and teams.

Responsibilities

• Partner with Analytical Development teams for commercial method readiness.
• Develop lifecycle strategies for analytical methods.
• Prepare and review technical documents for compliance.

Skills

ELISA

qPCR

western blot

ddPCR

SPR

automation

troubleshooting

problem-solving

Education

Bachelor's degree

Master's degree

PhD

Job description

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

Join us as a Senior Scientist, I- Analytical Development (On-site - Worcester, MA) at BioSpace.

Company Description: AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address future medical challenges. We aim to impact lives across key therapeutic areas such as immunology, oncology, neuroscience, and eye care, including products in our Allergan Aesthetics portfolio. For more information, visit www.abbvie.com. Follow us on social media: @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 within the Product Development Science and Technology, Biologics Development Launch division. This team develops, qualifies, and executes analytical methods to understand biological products from discovery to commercialization.

The successful candidate will be part of the Biomolecular Interaction Group, focusing on immunoassay development to monitor process impurities and assess potency of biologics. Techniques include ELISAs, surface plasmon resonance (Biacore), and qPCR. The role involves managing analytical aspects of biologics products on the market, overseeing methods throughout their lifecycle, establishing product specifications, stability programs, and supporting regulatory filings. Collaboration across analytical, process development, QC, and manufacturing teams is essential.

Responsibilities:

1. Partner with Analytical Development teams to achieve commercial method readiness using techniques like ELISA, bioassays, spectrophotometry, and compendial methods.
2. Participate in cross-functional, multi-site projects, overseeing method transfer, investigations, and troubleshooting.
3. Develop lifecycle strategies for analytical methods, including stability, specifications, and change management aligned with health authority standards.
4. Prepare and review technical documents for compliance, including validation protocols, reports, and regulatory submissions.
5. Support regulatory inspections and respond to deficiency letters.
6. Review and update methods, designing experiments for remediation and improvement.

Qualifications:

• Bachelor's degree with approximately 10 years, Master's with 8 years, or PhD with no experience required.
• Industry experience in method development, qualification, validation, and transfer for biological products.
• Skills in ELISA, western blot, qPCR, ddPCR, SPR, and automation.
• Proven ability to lead projects and teams, meeting deadlines and objectives.
• Strong troubleshooting and problem-solving skills.

Additional Information:

The salary range is based on geographic location, experience, and company policies. Benefits include health insurance, 401(k), paid time off, and participation in incentive programs. Compensation details are at the company's discretion and subject to change.

AbbVie is an equal opportunity employer committed to diversity and inclusion. For more info, visit here. Applicants seeking accommodations can find more information here.