Scientist II, Drug Product Development

WuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing.

About the role

The Drug Product Development (DPD) team is seeking a Scientist II to join our department. The successful candidate will work as part of a team focused on formulation development, drug product manufacturing process development and technical transfer, clinical in-use compatibility studies, and drug product manufacturing support. You will collaborate closely with analytical sciences (AS) and process development and drug product manufacturing teams to lead formulation development projects, ensuring study design, execution, and troubleshooting meet client project deliverables. This role involves authoring technical documents such as SOPs, protocols, and study reports.

Responsibilities

• Understand drug product manufacturing processes and scaling up, including liquid formulation development and fill/finish process scale-up.
• Develop formulations for biologics to support stability, including study planning, design, execution, and authoring study reports to manage the DPD project lifecycle.
• Develop analytical methods focusing on separation assays and biophysical characterization using techniques such as chromatography, mass spectrometry, electrophoresis, spectroscopy, and binding assays.
• Develop injectable drug product manufacturing processes, including container closure selection, drug product compatibility with manufacturing processes, and provide technical transfer and manufacturing support, including deviation investigation and troubleshooting.
• Author technical documents such as SOPs, protocols, study reports, and support regulatory filings.
• Play a key role in Formulation/DPD lab maintenance efforts, including equipment selection/procurement, data integrity audits, lab supply management, and supporting team-building activities.
• Apply scientific knowledge and experience to assigned projects, interfacing extensively in a matrixed environment with process development, analytical development, and manufacturing teams.
• Assess new formulation/DPD technologies and support ongoing and upcoming client projects.
• Communicate effectively on research and development findings internally and externally to ensure alignment among WuXi Biologics and with clients.

Qualifications

• PhD with 0-2 years of experience in Pharmaceutics, Pharmaceutical Sciences, Pharmaceutical Chemistry, or Chemistry.
• Knowledge in formulation development, high-concentration protein formulation, matching placebo development, and drug product process development areas.
• Understanding of current industry practices and scientific reasoning for biologics product formulation development.
• Strong communication skills and ability to build positive collaboration with internal stakeholders, vendors, and clients.
• Self-motivated, highly flexible, well-organized, and detail-oriented with the ability to manage multiple tasks.
• Willingness to work occasional evening hours and conference calls to accommodate global team time zones.

Preferred Experience

• Drug product process development experience with large molecules for parenteral administration.
• Development and characterization of aseptic fill and finish operations, including freeze/thaw, compounding, mixing, sterile filtration, filling, stoppering, and visual inspection.
• Manufacturing experience of biologics drug product in clinical settings.
• Experience in biophysical characterization of biologics drug products.

Pay

The anticipated salary for this position is $66,200 - $105,900.