Senior Scientist - Drug Product Development

Responsibilities

• Provide hands-on formulation and process expertise to develop clinical and commercial formulations for the solid oral dosage forms.
• Accountable for drug product process development and related analytical activities.
• Design and execute formulation experiments, organize and analyze results with minimal direction, and communicate and present in team meetings.
• Perform high-level risk assessment/failure modes and effects analysis for the manufacturing process and prepare technical reports.
• Work with external manufacturing CMOs to enable the transfer and implementation of processes and assist in the root cause analysis (RCA) process.
• Under the guidance of the Director of Drug Product Development, help implement and maintain a state-of-the-art drug product development laboratory.
• Interact effectively & build successful relationships with members of the drug product group and other Arcus stakeholders (Drug Substance, Quality, Analytical Development, Regulatory, Medicinal Chemistry, Clinical Operations & Discovery Biology).

Qualifications

• MS or PhD in Pharmaceutical Sciences, Material Sciences, Chemistry, Chemical Engineering, or other relevant fields of study
• 4 + years of experience for PhD and 7 + years of experience for MS candidates in the pharmaceutical industry, emphasizing oral solid dosage forms with in-depth understanding of typical manufacturing unit operations such as granulation, roller compaction, drying, milling, blending, compression/encapsulation, film coating, and spray drying etc.
• Experience in scale-up studies using the QbD approach and principles.
• Experience interacting with Contract Research/Manufacturing Organizations
• Experience in oral formulation development, drug product process development, and technology transfer.
• Experience with parenteral formulation will be a plus.
• Experienced in High-Pressure Liquid Chromatography (HPLC) as analytical tool for evaluating formulation stability.
• Experience with DSC, TGA, XRPD, and other advanced formulation scientific equipment.
• Strong interpersonal skills: ability to communicate effectively both verbally and in written formats are necessary to collaborate effectively with the rest of the Drug Product Development team and well as across other teams
• Detail-oriented, rigorous, and excellent skills in record keeping/documentation
• Proven ability to think creatively, learn new technologies and obtain solutions to complex and diverse problems