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