Intern, Pharmaceutical Engineering, Drug Product, PDM

Revolution Medicines • Redwood City, CA

9h • $67,000 - $81,000 • Hybrid

About The Position

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: Playing an important role as engineering support within the Drug Product team, and working closely with Scientsts and Process Engineers within the group. A successful candidate will be responsible for supporting clinical-stage and late-stage process developments as well as supporting preparation for Process Performance Qualification of Revolution Medicines’ compounds. Work closely with Scientists and Process Engineers within Drug Product group to support the transition of drug product manufacturing from clinical stage development through late stage development and Process Performance Qualification (PPQ). Support formulation and process development and optimization studies conducted according to the principles of Quality by Design (QbD), using tools such as OFAT (one factor at a time) experiments and DOE (Design of Experiments). Review protocols, manufacturing batch records, and development, campaign, and technical reports for clinical-stage and late-stage manufacturing. Analyze data and perform statistical analysis to support process development and optimiziation, process capability, and process range justification. Build and maintain databases to manage and track experimental data and results for multiple Programs. Conduct literature reviews and stay updated on the latest advancements in drug product development and manufacturing.

Requirements

• Working towards a BS or MS or Ph. D in Chemical Engineering, Pharmacetuical Sciences, or related discipline.
• Strong problem-solving skills with sound technically driven decision-making ability.
• Effective written and verbal communication skills and interpersonal skills.
• Ability to review and interpret technical documents and protocols.
• Strong organizational skills and attention to detail.
• Ability to work collaboratively in a team environment.

Nice To Haves

• Familiarity with regulatory requirements and guidelines in the pharmaceutical industry.
• Knowledge of Quality by Design (QbD) principles and tools such as OFAT and DOE a plus.
• Proficiency in statistical analysis software (JMP) a plus.

Responsibilities

• Support clinical-stage and late-stage process developments as well as supporting preparation for Process Performance Qualification of Revolution Medicines’ compounds.
• Support the transition of drug product manufacturing from clinical stage development through late stage development and Process Performance Qualification (PPQ).
• Support formulation and process development and optimization studies conducted according to the principles of Quality by Design (QbD), using tools such as OFAT (one factor at a time) experiments and DOE (Design of Experiments).
• Review protocols, manufacturing batch records, and development, campaign, and technical reports for clinical-stage and late-stage manufacturing.
• Analyze data and perform statistical analysis to support process development and optimiziation, process capability, and process range justification.
• Build and maintain databases to manage and track experimental data and results for multiple Programs.
• Conduct literature reviews and stay updated on the latest advancements in drug product development and manufacturing.

What This Job Offers

• Career Level: Intern