Director/Sr. Director CMC Project Management

Thank you for your interest in a career at Senti Biosciences. Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases in ways previously inconceivable. We are passionate about designing gene circuits to improve the “intelligence” of cell and gene therapies in order to enhance their therapeutic effectiveness against a broad range of diseases that conventional medicines are unable to address.
 
At Senti, we find purpose and meaning knowing that our efforts have the potential to improve the lives of patients and their families with more effective and safer treatment options. With science as our foundation and empathy as our key guiding principle, colleagues become friends, managers become mentors, and with time, cancer becomes history.

Summary: The Director/Sr. Director of CMC Project Management will lead the cross-functional activities between CMC groups and other departments at Senti Biosciences to achieve product development goals across Senti’s portfolio. A successful candidate will have extensive knowledge of cell/gene therapy CMC development,  including process and analytical development,  tech transfer to GMP, and manufacturing operations and supply chain.  This individual will also work closely with preclinical research, quality and regulatory, and clinical teams to coordinate program needs. This position will contribute to ensuring alignment with corporate goals and the efficient distribution of information through multiple levels of the organization. 
Responsibilities:

• Develop, maintain, and track product development plans (e.g. Budget, resources, etc.) with SMEs to encompass key program milestones and deliverables in alignment with overall program objectives with experience/familiarity in: Process characterization, raw material sourcing and qualification, supply chain and distribution, analytical method and process characterization and validation, and regulatory submissions for early development through commercialization
• Build and maintain strong relationships with internal and external teams (PD, Manufacturing, AD/QC, QA, Regulatory, research, clinical) to ensure program goals and accountabilities
• Own the vendor project management relationship and support tech transfer and vendor management 
• Routinely communicate schedule/project adherence and risks to senior leadership
• Proactively identify risks, gaps, and resource bottlenecks, and work with impacted teams and functional leadership to develop and implement mitigation plans
• Facilitate internal program and CMC team meetings using meeting management best practices (both what and how) to drive cross-functional communication, timely and effective decision-making, and successful execution of program activities
• Support the standardization of processes and communication(s) to build efficiencies 
• Proactively seek out opportunities for organizational and operational improvement (e.g. team structure, processes, communication, etc.)
• Direct management of a project management team, responsible for training, career development, and establishing best practices

Qualifications:

• Bachelor’s Degree in any discipline required
• Advanced degree (MS or PhD) in Life Sciences preferred
• 8+ years of industry experience with 3+ years of CMC Program Management experience in biomedical industry. Cell/gene therapy preferred
• 3+ years of experience working with biological systems specifically: GMP manufacturing; process development, characterization, and validation; analytical method characterization and validation; and regulatory submissions for early development through commercialization
• 1-2+ years of experience working with FDA regulated Quality systems
• Experience with Business Process Management, and Operational Excellence toolset(s) such as Toyota Way, Lean, and Six Sigma, within the BPM framework, is desirable
• Strong communication skills with ability to build professional relationships with external and internal stakeholders a must
• Attention to detail and accuracy with respect to internal and external reportingStrong business acumen
• PMP® certification preferred
• Strong understanding of US FDA regulations and ICH guidelines for cell and gene therapy products is preferred

Salary and Benefits:

• Compensation for this role includes base salary, annual target bonus and equity
• The base salary range for this role is $226,000 - 246,000. Starting pay is determined by multiple job-related factors including a candidate’s skills, education and experience level, benchmark, and internal parity
• Significant growth opportunity as the company expands
• Empathetic, supportive and collaborative colleagues and work environments

Senti Bio is a publicly traded (Nasdaq: SNTI) gene circuit company headquartered in South San Francisco. Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases using novel and unprecedented approaches.

We are committed to an inclusive and diverse Senti Bio. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse Senti Team. We welcome people of different backgrounds, experiences, abilities and perspectives and are an equal opportunity employer.