Director CMC (Chemistry, Manufacturing, Control)

Who are we?

Compugen’s extraordinary multidisciplinary team is one of its greatest assets. Our employees, coming from different backgrounds with diverse ways of thinking, work together in an atmosphere that cultivates excellence, creativity and openness. The cooperation of people from various disciplines involving different areas of expertise is fundamental to our ability to establish a unique predictive drug discovery infrastructure, as well as to discover and develop novel therapeutic proteins and drug targets. This merging of talent from various disciplines continues to serve as a key growth driver and enables us to fulfill our mission and business goals.

We are looking for?

With already several fast-growing proprietary programs in clinical development stage, either directly or through partnerships, along with new novel programs from our internal discovery engine, UnigenTM Compugen is actively seeking a Director of CMC. This position will be within the Preclinical Development & Corporate Operations Unit and will report to the Chief Operating Officer.

The Director of CMC is responsible for establishing the CMC development plan and for ensuring its execution from preclinical through commercial development for all Compugen programs, in accordance with the defined global strategy.

Qualification:

• Establish and lead the CMC development plans for drug substances and drug products from late research – preclinical stage through commercial development
• Contribute to the assessment of developability for programs at early stage and contribute to the triage process with research and discovery teams
• Maintain and enrich the existing portfolio of third-party contract manufacturers or vendors, including contract analytical laboratories as required by the specificities of Compugen programs, in close relationship with Quality and Regulatory functions
• Oversee contract parties related to all CMC functions, including USP and DSP manufacturing, technology transfer, process and analytical method development, optimization, characterization, qualification and validation testing, stability, release, comparability campaigns, regulatory filings, packaging, and labeling operations. Guide the associated operations, through or in association with a project manager when needed
• Contribute to internal cross-functional project teams or with external partner(s) as a CMC functional representative/subject matter expert
• Contribute to Compugen quality system documentation for CMC area, working with Quality Assurance function
• Ensure that CMC activities, including externalized, adhere to Compugen policies and comply to relevant regulations
• Prepare international CMC regulatory filings and agencies consultation, working with Regulatory and Quality functions
• Review CMC development and production plans prepared or adjusted by CMC project manager to support preclinical, clinical, and commercial development
• Prepare synthesis about CMC questions in the form of reports or presentations as needed, in close collaboration with Project Management functions, to enable key strategic program decision-making by Company management
• Maintain state-of-the-art knowledge on CMC activities for biologics and propose implementation of new methods or technologies when emerging innovations may be beneficial for Compugen programs

Responsibilities:

• Scientific background (MS, Ph.D., PharmD or equivalent) in a discipline relevant to CMC, such as chemistry, biochemistry, protein engineering, molecular biology, immunology
• 5+ years of hands-on experience in contract manufacturing, biotechnology or pharmaceutical industry, in the field of biologics, preferably monoclonal antibodies
• Experience with innovative biologics modalities (e.g., bispecific/multi specific antibodies, fusion proteins, etc.) is desirable
• Track-record of experience in direct management of key activities related to CMC of biologics, from developability assessment to clinical stage
• Exposure to regulatory interactions, consultations, or filings
• Exposure to in/out due diligence processes is a plus
• Ability and motivation to work and develop a team spirit internally and with partners
• Demonstrated leadership to work with CDMOs, vendors, external advisors, or partners
• Good understanding of ICH, GMP, FDA regulations and guidelines relevant to CMC of biologics. Exposure to other CMC regulations such as Europe would be an advantage
• Efficient analysis and synthesis of data
• Result-oriented, facilitator for problem solving
• Ability to travel for missions, visits, audits to subcontracted facilities