Senior Scientist, II CMC Sciences Biologics Development and Launch (BDL) -Remote Role

BioSpace; Boston (MA); Remote; USD 95,000 - 145,000; Full time

Job summary

A leading company in biologics is seeking a Senior Scientist II for a remote role within their CMC Sciences team. This position entails authoring vital regulatory documents and coordinating cross-functional teams through various development phases. Ideal candidates will possess extensive industry experience and a relevant degree, contributing to program efficiencies and regulatory compliance efforts.

Benefits

Comprehensive benefits package

Eligible for short-term and long-term incentive programs

Qualifications

• 8+ years of industry experience with a BS; 6+ years with MS; 3+ years with PhD.
• Proficiency in Microsoft Word and Excel.
• Understanding of scientific/regulatory requirements.

Responsibilities

• Author regulatory documents like INDs and BLAs.
• Lead teams in developing control strategies.
• Drive alignment with stakeholders and escalate issues.

Skills

Knowledge of biologics manufacturing processes

Cell culture

Purification

Process development

Good Documentation Practices (GDP)

Proficiency in Microsoft Word

Proficiency in Microsoft Excel

Education

BS or higher in Biology, Biochemistry, Engineering, or related field

Job description

Senior Scientist, II CMC Sciences Biologics Development and Launch (BDL) - Remote Role

This role supports regulatory approval of biologics drug substances by authoring Chemistry, Manufacturing, and Controls (CMC) filing content and leading cross-functional CMC teams throughout Phase 1, 2, and 3 development.

Responsibilities include:

• Authoring sections of regulatory documents, including INDs and BLAs, based on source documentation.
• Partnering with subject matter experts in process development to ensure accurate technical information in regulatory documents.
• Leading CMC teams in developing control strategies and presenting Control Strategy Reviews (CSRs).
• Driving alignment with stakeholders such as Product Development Directors, Development Sciences, and Quality Assurance, and escalating issues when necessary.
• Contributing to program acceleration and efficiency initiatives.

Qualifications:

• BS or higher in Biology, Biochemistry, Engineering, or related field, with 8+ years of industry experience; MS with 6+ years; PhD with 3+ years.
• Knowledge of biologics manufacturing processes, cell culture, purification, and process development.
• Understanding of Good Documentation Practices (GDP) and scientific/regulatory requirements.
• Proficiency in Microsoft Word and Excel.

Additional Information:

• Salary range varies based on location and experience, with a comprehensive benefits package.
• Eligible for short-term and long-term incentive programs.

Note: Compensation details are subject to change and are not guaranteed until paid.

AbbVie is an equal opportunity employer committed to diversity and inclusion. For more info, visit here.