Associate Director, Package Engineer

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 scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

Revolution Medicines is seeking a motivated individual with a packaging engineer to play a critical role in overseeing the end-to-end packaging operations of our pharmaceutical drug products. The candidate will be responsible from design, development, validation, and commercial launch ensuring that all packaging processes comply with regulatory requirements and meet the highest standards of quality and efficiency.

The Opportunity :

• Oversee the packaging activities of Revolution Medicine's clinical and commercial assets.

• Build the packaging team accountable for the end-to-end packaging design, development and manufacturing activities.

• Align packaging activities with company objectives and regulatory requirements.

• Ensure that all packaging operations adhere to relevant regulatory guidelines, including FDA and international regulatory requirements.

• Identify opportunities for process optimization and improvement within the packaging department to enhance efficiency, reduce costs, and improve product quality.

• Collaborate closely with other departments, including Formulation and Process Development, Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain, to ensure seamless integration of packaging processes with overall drug product manufacturing and distribution operations.

• Potentially lead and mentor a team of packaging professionals, providing guidance, coaching, and support to foster their professional growth and development.

• Oversee relationships with packaging material suppliers and contract packaging organizations, ensuring that they meet quality and performance standards.

• Evaluate new packaging technologies and equipment to enhance capabilities and improve efficiency in drug product packaging operations.

• Manage the packaging department budget effectively, ensuring that resources are allocated efficiently to support departmental objectives.

• Drive a culture of continuous improvement within the packaging department, implementing best practices and quality standards to achieve operational excellence.

• Maintain accurate documentation of packaging processes, procedures, and performance metrics, and provide regular reports to senior management on departmental activities and achievements.

Required Skills, Experience and Education:

• BS or MSc degree in chemical engineering or related discipline with 10+ years of relevant experience in pharmaceutical packaging

• Hands on experience in non-good manufacturing practices (GMP) and clinical and commercial GMP packaging and labeling expertise

• Knowledge of current International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, GMP guidelines, and related industry practices

• Working experience and knowledge of regulatory submission (Investigational New Drug (IND), Investigational Medicinal Product Dossier (IMPD), and / or New Drug Application (NDA).

• Strong problem-solving skills with sound technically driven decision-making ability

• An innovative team-player with capacity to be effective in a dynamic and fast-paced company environment.

Preferred Skills, Experience and Education

• Proven track record of successfully leading and managing packaging related activities in a pharmaceutical manufacturing environment.

• Proven track record of end-end packaging of drug product.

• Excellent communication, interpersonal, and leadership skills.

• Ability to think strategically and drive results in a fast-paced, dynamic environment.

The expected salary range for this role is $160,000 to $200,000. An individual's position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. Base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition and veteran status.

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