Project Manager, Tech Ops at Senti Biosciences
Alameda, CA, US
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:
We are seeking a Project Manager to lead medium to large-scale projects for a multi-product allogeneic start-up manufacturing facility focusing on manufacturing operational readiness and quality systems implementation and subsequent transition to regular operations. You will develop the strategy and manage critical path timelines for integrated manufacturing and quality activities, as well as the budget for GMP manufacturing readiness at the new manufacturing facility in Alameda.
 
Types of projects within the portfolio include facility construction, equipment procurement, commissioning and qualification of facility, equipment and processes, facility capital expansion, tech transfers, manufacturing process changes, ERP and QMS implementation, CAPAs and risk remediation, Operational Excellence projects, manufacturing scheduling and coordination, external vendor management, lab and facilities operations project management, and other projects as needed.

Responsibilities:

    • Lead cross-functional project teams, to deliver the objectives of medium/high-level complexity projects
    • Effectively manage team meetings, including the scheduling of meetings, the preparation of agendas, the development of meeting minutes, and the follow up on action items
    • Management and reporting of OKRs (Objectives and Key Results) and KPIs (Key Performance Indicators), including timelines, budgets, milestones, and escalations
    • Proactively identify, communicate, and escalate risks and decisions to site leadership
    • Work with team Subject Matter Experts (SMEs) to develop contingency plans when required
    • Be responsible for the preparation of routine status reports and communicate project progress to stakeholders, supervisors, site leadership, and various governance forums as needed
    • Promote a culture of collaboration, cooperation, execution excellence, effective communication, and cross-functional problem-solving to enable a high-performing team.
    • Develop and manage continuous improvement projects in partnership with Operational SMEs
    • Support internal and external audit activities; scheduling, preparation, readiness, and planning.
    • Collaborate with SMEs from the following (but not limited to) functions: Manufacturing Operations, Supply Chain, Manufacturing Science and Technology (MS&T), Quality Assurance, Quality Control, Process Development, Facilities, IT, EHS, Finance, Regulatory, and other Business Process initiatives.
    • Serve as a member of sub-teams, tracking timelines elements to ensure that functional deliverables are completed on time and according to relevant quality standards
    • Ensure adherence to applicable project budgets and propose capital appropriation requests where applicable

Qualifications:

    • Bachelor’s degree in engineering or a life sciences field (or equivalent experience required), PMP certification preferred
    • 3-5+ years of relevant project management experience required in pharmaceutical, biotechnology, or related industries
    • Demonstrated high degree of business acumen, with the ability to deliver executive-level presentations, challenge assumptions and drive decision making
    • Direct experience with cGMP manufacturing of clinical therapeutics
    • Direct experience with cell and gene therapy GMP manufacturing preferred
    • Technical knowledge of cell/gene therapy processes
    • Greenfield/brownfield of a GMP facility (preferably cell/gene therapy) through design, construction, and commissioning preferred
    • Strong understanding of current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements (EMA, TGA).
    • Experience with Business Process Management, and Operational Excellence toolset(s) such as Toyota Way, Lean, and Six Sigma, within the BPM framework, is desirable.
    • Be a decisive decision-maker and problem solver to support timely result delivery and customer satisfaction
    • Self-motivated and passionate about advancing the field of cell therapies
    • Self-awareness, integrity, authenticity, and a growth mindset
    • Flexible and comfortable working with ambiguity
Senti Bio is a leading gene circuit company designing gene circuits to create a new generation of “smarter medicines" and enhance the therapeutic effectiveness of cell and gene therapies against a broad range of diseases that are unaddressed by current standards of care. We are proud to count Leaps by Bayer, NEA, 8VC, Matrix Partners China, Mirae Asset Capital, Amgen Ventures, and others among our investors. In December 2021, Senti Bio and Dynamics Special Purpose Corp. (Nasdaq: DYNS), a special purpose acquisition company (SPAC), announced a definitive business combination agreement to create a public company focused on Gene Circuit-engineered cell and gene therapies. The transaction is expected to be completed in the second quarter of 2022. Senti Bio is based in South San Francisco, CA, USA.
 
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.