Sr. Director, CMC

Rubedo Life Sciences is a biotechnology company with active research programs related to age-related diseases including cancer and respiratory disorders. We are seeking a motivated and enthusiastic leader to join our team. Together, we will discover and develop novel therapies that target the pathologic cells that drive aging and age-related diseases.

Position Summary:

Responsible for phase appropriate development and manufacturing of small molecule drug substance and drug products across Rubedo’s programs, from the preclinical stage through clinical development.

Essential Functions:

• Develop the CMC organization as needed to keep pace with the development of the Company’s clinical pipeline
• Prepare and execute development plans appropriate to each drug and phase of development.
• Develop target profiles, milestones, timelines and budgets in alignment with management
• Provide transparency around planning, decisions and progress
• Identify, evaluate and ensure that outsourced vendors have the required scientific expertise, capabilities, and quality/compliance standards.
• Accountability for timely supply of product to support clinical trials.
• Review report(s) to ensure scientific integrity and compliance with regulatory requirements.
• Oversee authoring of CMC modules and ensure suitability for regulatory filings
• Ensure that all Company manufacturing work is conducted in a manner that is in full compliance with all pertinent regulations and consistent with industry standards.
• Represent the Company externally on CMC matters with relevant stakeholders.
• Support business development activities with documentation, presentation, and due diligence discussions with potential partners
• Would be approximately 20% travel (vendor sites)

Preferred Experience:

• Minimum of 15 years experience in a related position in a pharmaceutical or biotech company.
• An understanding of the drug development process from lead candidate selection through NDA filing
• Thorough understanding of accepted practices for early stage development
• Experience with vendor qualification and management
• Experience with a broad range of dosage forms for systemic as well as local administration
• A track record of innovation, self-starting and success working in a multi-disciplinary team under defined and demanding timelines
• Proven management and leadership experience
• Core expertise in analytical sciences and analysis of product testing data preferred
• Experience operating under GMP guidelines with a strong operating knowledge of quality principles.
• Experience in preparing for, presenting to and negotiating with regulatory agencies.

Preferred Education:

• PhD in an area of chemistry, pharmaceutical sciences or a related field.

Preferred Additional Skills:

• Prioritize and communicate priorities effectively within a fast moving and matrixed environment.
• Delegate work effectively, while being willing to be a “hands-on, roll-up-your sleeves” leader in a lean organization.
• Ability to analyze and communicate data in an objective and concise manner.
• Strong leadership and management skills.
• Excellent teamwork and collaboration skills.
• Effective process and project management skills.
• Outstanding written and verbal communication skills.
• Independent, innovative, and creative thinker.
• Strong organizational and interpersonal skills.
• Excellent team interaction skills along with demonstrated ability to work in a cross-functional team and influence the decisions of a team.
• Ability to demonstrate effective leadership in ambiguous and frequently changing situations.

Environmental Conditions / Physical Demands:

• Environmental risks: Exposure to wet lab environment, bloodborne pathogens, and toxic or caustic chemical or reagents
• Work location: Sunnyvale, CA, USA

Rubedo Life Sciences, Inc. is an equal opportunity employer and values diversity at our company.