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.
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.
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)
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.
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.