Senior Scientist II, Biologics Drug Product Development

Role Summary

Senior Scientist II, Biologics Drug Product Development, located in North Chicago, IL. You will lead biologics drug product formulation and process development, modeling, scale-up and tech transfer. The role will be an integral part of the product development and CMC teams, collaborating with discovery research, analytical development, bioprocess development, combination products development, product development science and technology, pilot plants, and third-party manufacturers.

Responsibilities

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

Qualifications

• Required: PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines with 4+ years of relevant industry experience.
• Required: Proven ability to solve critical scientific problems.
• Required: Experience with biologics (proteins, conjugates, peptides and/or neurotoxins), parenteral synthetic molecules and/or genetic medicine (AAV, LNPs, cell therapy) drug product process development.
• Required: 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.
• Required: Hand-on experience with authoring regulatory filings for biologics and sterile parenteral products
• Required: Experience leading drug product development as the functional lead within cross-functional teams
• Preferred: Biologics drug product formulation development
• Preferred: Understanding of relevant cGMP and regulatory guidance for biologics and sterile parenteral products
• Preferred: Experience in managing third party manufacturers of sterile parenteral products
• Preferred: Experience with quality risk management and control strategies for biologics and sterile parenteral products

Skills

• 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.
• Builds 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.

Education

• PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines.