
Senior Scientist - Drug Product Development
Arcus Biosciences
Hayward, CA
Science / R&D / Research, Analyst, Information Technology
Summary
The Sr. Scientist 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).
- 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
- Experienced 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
Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
Physical Requirements Office Setting
Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.
About the company
Company website•Biotechnology
Arcus Biosciences is a rapidly growing, clinical-stage, global biopharmaceutical company developing differentiated molecules and combination medicines that may have the potential to help people with cancer live longer.
Located in the San Francisco bay area, Arcus Biosciences offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. Arcus has an ambitious undertaking and expects to become a force in the discovery, development and commercialization of novel combination therapies to treat cancer in areas of high unmet need. Our employees enjoy operating in an exceptionally dynamic and team-driven environment in which the “rule book” has not yet been written.
