Poseida is seeking an outstanding Project Manager to join our team. The Project Manager is a key member of the organization and will partner with internal team leaders and external partners to develop, track, and implement various projects to support our therapeutic programs. The ideal candidate will have the ability to identify, implement, and organize programs across cross-functional teams. The Project Manager will collaborate with teams to develop program strategy and timelines through completion.
These may include but are not limited to:
- Work with cross functional teams to evaluate opportunities, analyze the scope, and support endorsed projects
- Assist teams in evaluating projects, prior to initiation, to ensure they contribute to pre-identified goals and objectives
- Maintain a systematic structure that drives project visibility to senior leadership through defined PMO methodology
- Assists the team with determining the prioritization of opportunities based on critical business needs and defined organizational strategy plan
- Provides a proactive approach to driving projects and identifying areas for risk mitigation
- Creates, maintains, optimizes and publishes program dashboards on routine intervals
- Coordinate and facilitate projects that are cross functional/organizational to drive actions and decision making
- Identify and help manage risks, conflicts and barriers to enable project success
- Incorporate project management tools that drive scope focus, team accountability, deliverables, timelines, implementation, and effectiveness checks
- Directly manage projects with minimal supervision
- Identify deliverables and inter-dependencies associated with projects
- Routinely challenge the status quo to drive optimization and efficiencies
- Identify and engage appropriate stakeholders to establish well-rounded and represented project teams, including but not limited to Technical Operations, Supply Chain/Procurement, Quality, Facilities, Regulatory, and Finance
- Incorporate financial and resource allocation aspects into project plans
- Identify project and resource gaps to facilitate resolution(s)
- Assist in representing various cross functional internal teams with external partners/vendors, including contract development
- Ensure team decisions are clearly communicated and act as a single point of contact for project related information
- Responsible for leading high impact activities across functional initiatives
- Lead the planning and implementation of projects supporting manufacturing operations (vein to vein)
- Support Operations (Supply Chain/Procurement, Quality, Technical Operations, Facilities) by ensuring that the business model aligns with organizational goals (increase capacity, business continuity, decreased throughput, decreased COGs, etc.).
- Present reports defining project progress, risks, and proposed solutions
- Implement and manage project changes and interventions to achieve project outputs
- Support portfolio of initiatives impacting internal manufacturing operations in addition to contract manufacturers.
Requirements, Knowledge, Skills and Abilities
- Must have a BS/BA degree; higher education degree preferred (MBA, MBS, PHD)
- Must have a minimum of 8 years of multi-disciplinary experience within pharmaceutical or biotechnology industry with at least 5 years project management experience (an equivalent of education and experience may be considered)
- Background in biologics and/or immuno oncology
- In-depth knowledge and experience in pharmaceutical manufacturing for both clinical and commercial applications
- Experience managing Industry and regulatory submission enabling projects (IND, BLA, etc.)
- Knowledge of CMC requirements and regulatory submissions preferred
- Experience supporting regulatory inspections (PAI, Routine Audits, etc.)
- Strong proficiency with project management practices, tools and methodology including Gantt Charts, MS Project and Power Point
- Complex Problem-solving abilities with focus on accomplishing company goals and objectives in a dynamic business environment
- Outstanding written and oral communication and negotiation skills are essential
- Must have strong interpersonal skills capable of working with a diverse group of people
- Strong leader with focus and drive to succeed—confidence, passion, results oriented and high energy
- Ability to present thoughts clearly and concisely to a wide variety of stakeholders including senior management, directors, and corporate partners
- Knowledge of Project Management Professional (PMP) applications preferred
- Knowledge and experience in Gene and/or cell therapy, Assay development, Process Characterization, Validation, Qualification
- Knowledgeable in Operational Excellence (Lean Six Sigma)
- Experience in establishing and measuring Key Performance Indicators (KPIs) and reporting status and progress
- Strive toward excellence to support the organization by mitigating gaps identified to ensure business continuity.
- Travel can be anticipated up to ~20%
Who We Are and What We Do
Poseida is a San Diego based biotechnology leader in the development of cell and gene therapies. We have built a wholly-owned pipeline of autologous and allogeneic chimeric antigen receptor T cell, or CAR-T, product candidates, initially focused on the treatment of hematological malignancies and solid tumors. Here at Poseida we are constantly innovating and growing as we advance our CAR-T therapies in the clinic and our gene therapies currently under development. The Poseida team is passionate about the impact we are making in developing treatments, or even cures, for patients with cancer or other genetic diseases.
The company’s CAR-T product candidates are manufactured with Poseida’s non-viral piggyBac® DNA Modification System, resulting in a high percentage of stem cell memory T cells (TSCM). Tscm cells are the only T cells that are self-renewing and long-lived, potentially resulting in product candidates that are more efficacious, less toxic and more durable. Poseida is currently developing the following CAR-T product candidates:
- P-BCMA-101 is an autologous CAR-T therapy for the treatment of relapsed/refractory multiple myeloma, currently enrolling patients for a Phase 2 registrational trial with initial dosing expected in the first half of 2019.
- P-PSMA-101 is an autologous CAR-T product candidate targeting PSMA-specific cancer cells in castrate resistant prostate cancer, with filing of an IND anticipated in the second half of 2019.
- P-BCMA-ALLO1 is an allogeneic, or universal donor, CAR-T product candidate, manufactured using Poseida’s proprietary Cas-CLOVER™ site specific gene editing system and is being developed as a treatment for relapsed/refractory multiple myeloma, with an IND filing anticipated by late 2019 or early 2020.
- P-MUC1C-101 is an autologous CAR-T product candidate in late-stage preclinical development for numerous solid tumor indications, including ovarian, breast, lung, colorectal, pancreatic and renal cancers, with filing of an IND anticipated in 2020.
Poseida plans to broadly advance its current CAR-T programs and emerging pipeline programs, including gene therapies for orphan genetic diseases.
To apply send your resume and cover letter to firstname.lastname@example.org.