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Senior Scientist / Principal Investigator - Drug Product Development

Company: Arcus Biosciences, Inc.
Location: Hayward
Posted on: January 11, 2022

Job Description:

Summary-- -The Sr. Scientist/Principal Investigator-- -will provide hands-on formulation and process expertise primarily in solid oral formulations related activities and present scientific data in the drug product development function.-- -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-- -PhD in Pharmaceutical Sciences, Material Sciences, Chemistry, Chemical Engineering, or other relevant fields of study7+ years of experience 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, etc.Experience in scale-up studies using the QbD approach and principles.Experience interacting with Contract Research/Manufacturing OrganizationsExperienced 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 across other teamsDetail-oriented, rigorous, and excellent skills in record keeping/documentationProven ability to think creatively, learn new technologies and obtain solutions to complex and diverse problems

Keywords: Arcus Biosciences, Inc., Hayward , Senior Scientist / Principal Investigator - Drug Product Development, Other , Hayward, California

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