Principal Scientist/Associate Director, Analytical Development & Clinical Quality Control

POSITION OVERVIEW:

Reporting to a Director of Analytical Development/Clinical QC, this position requires expert knowledge of the biopharmaceutical drug development process in late-stage development, with working knowledge and experience in method development, transfer of analytical methods, and management of external vendors. This individual will contribute to late-stage analytical development strategy and content of regulatory filings. Excellent communication skills, attention to detail, and organizational skills are essential for this role.

RESPONSIBILITIES:

• Characterize biologic therapeutics using standard analytical extended techniques to explore relationships between structure and function. These techniques include but are not limited: chromatographic techniques (CEX, SEC, HILIC, etc.), mass spectrometry-based techniques including peptide mapping (LC/MS) and intact mass, capillary electrophoresis, differential scanning calorimetry (DSC) or fluorimetry (DSF), glycosylation content measurement, ELISA, and potency assays.
• Oversee development of standard protein analysis methods through external vendors and guide transfer analytical methods to separate analytical and QC testing facilities.
• Develop analytical techniques to measure product and process impurities.
• Strengthen relationships with external CDMO partners to establish and manage appropriate scopes of work, and to ensure all activities are within program expectations.
• Provide oversight into external testing facilities for non-GMP and GMP testing.
• Lead method performance investigations, troubleshooting, and laboratory investigations.
• Working and up-to-date knowledge of ICH guidelines and other regulatory guidance.
• Author, review and edit SOPs, protocols, reports, and quality related documentation for internal and external stakeholders.
• Provide authorship and review for regulatory documents for multiple countries.
• Collaborate cross-functionally across multi-disciplinary teams including Analytical Development, Process Development, Drug Product Development, Regulatory, Quality Assurance, Supply Chain, and others.

 REQUIREMENTS:

• Bachelors degree is required. An advanced degree (M.S./Ph.D.) is preferred.
• 10-12+ years of related experience in the biopharmaceutical industry experience, with 2+ years in late-stage development of antibody or related therapeutics.
• Hands-on experience with multiple analytical methods and specification development; troubleshooting experience with analytical methods using external vendors
• Good knowledge of cGMP and global regulatory requirements.
• Develop relationships and collaborate well with cross-functional groups, including Process Development, Manufacturing, Quality, and Regulatory.
• Self-starter with demonstrated ability to deliver high-quality results in a fast-paced development environment. Ability to effectively prioritize and deliver on tight timelines while remaining flexible in a changing environment.
• Excellent communication and interpersonal skills; ability to convey complex ideas succinctly.
• Experience in IND and BLA filings is highly desired.
• Ability to travel occasionally