Principal Scientist I, Biologics Drug Product Development

About the role

Biologics Drug Product Development (Bio DPD), a part of Development Sciences within AbbVie’s R&D, is a global organization responsible for drug product formulation and process development, and definition of the product presentation for biologics (proteins, conjugates, peptides, neurotoxins etc.) and genetic medicine (AAV, LNPs, Cell Therapy).

Responsibilities

• Represent Bio DPD in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC Team.
• Effectively and timely communicate development plans, risks, and mitigation plans to stakeholders and line management.
• Support scale-up and technology transfer activities to internal and external manufacturing sites.
• Lead the design and execution of biologics drug product formulation and process development, characterization and robustness studies.
• Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and platforms, and improve business processes.

Qualifications

• BS, MS, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines with- Principal Scientist I: 14+ (Bachelors), 12+ (Masters), or 6+ (PhD) years of relevant industry experience.
• Proven ability to solve critical scientific problems.
• Experience with biologics (proteins, conjugates, peptides and/or neurotoxins), parenteral synthetic molecules and/or genetic medicine (AAV, LNPs, cell therapy) drug product process development.
• Experience with sterile manufacturing unit operations (freeze-thaw, compounding, mixing, filtration and filling, lyophilization), characterization, scale-down models, simulation, scale-up, technology transfer, and batch record authoring.
• Experience leading drug product development as the functional lead within cross-functional teams.

Preferred Qualifications

• Hand-on experience with authoring regulatory filings for biologics and sterile parenteral products
• Understanding of relevant cGMP and regulatory guidance for biologics and sterile parenteral products
• Experience in managing third party manufacturers of sterile parenteral products
• Experience with quality risk management and control strategies for biologics and sterile parenteral products

Key Competencies

• Deep scientific knowledge and significant hands-on experience with drug product process development and tech transfer
• Effectively communicates to influence without authority, drives technical excellence, and inspires continuous improvement.
• Buils strong relationships with peers and cross-functional partners to enable higher performance.
• Connects ideas from disparate fields, integrates data and information quickly, and takes risks to achieve the highest performance.
• Raises the bar and is never satisfied with the status quo.
• Creates a learning environment, open to suggestions and experimentation for improvement.
• Embraces the ideas of others, nurtures innovation and manages innovation to reality.

Pay

$109,500 - $208,500 USD