Senior CMC Project Manager

Company Overview

Pluristyx is a four-year-old Seattle based biotech company providing consulting, contract development services, and novel products to our customers in the area of regenerative medicine and advanced cellular therapies. This entire field is experiencing explosive growth thanks to the astonishing potential for these new therapies to profoundly affect the lives of patients with unmet medical needs and with the promise to revolutionize how serious diseases and injuries are treated. Pluristyx has also been experiencing rapid growth due to high demand for our unique technical expertise, capabilities, and our proprietary stem cell-based products.

Position Overview

Pluristyx is seeking an enthusiastic and self-driven individual to join our team in the role of a CMC Project Manager.  The position will primarily be responsible for acting as a Project Manager working across the Pluristyx functional areas in support of both internal and external projects related to the development and manufacture of cell-based products;  internal projects include product and technology development while external projects are related to laboratory services and contract consulting.  The candidate may also work with Executive Management, Business Development, and the functional area leads on strategy and work plans for new projects (e.g. defining customer product/service requirements, developing work plans and timelines, budget and resource projections).   The successful candidate should have demonstrated experience leading multi-disciplinary teams, project management, and driving cell therapy manufacturing projects to completion.  

Primary Responsibilities

The position will have responsibilities that include:

• Act as a Project Manager in the completion of both internal and external projects
  • Provide project management and leadership support over on-going internal and external projects
    • Partner with key internal stakeholders to define initial timelines and deliverables
    • Organize and run regular team meetings; take responsibility for setting agendas, taking meeting notes, tracking of action items and key decisions
    • Ensure coordination among stakeholders; apply technical expertise to proactively anticipate potential technical or scheduling issues
  • Provide leadership in facilitating the resolution of project challenges (e.g. resource and scheduling conflicts, technical obstacles) by proposing solutions and/or elevating to subject matter experts, decision makers, and other stakeholders
  • Establish project management tools and practices that can be applied to both internal and external projects  (e.g.  budgeting tools, project dashboards, rolled-up Gantt charts)

• Coordinate across the Pluristyx functional areas to facilitate the evaluation and prioritization of new internal and external projects
  • Partner with business development and functional areas (e.g., technical, legal, finance) on proposing and closing external product, service, or consulting projects.   This function may include leading or participating in drafting work plans, negotiating service agreement terms, setting strategy, and working with project sponsors
  • Partner with executive management and internal technical teams to define scope of internal projects.   This may include working with functional teams to define deliverables, product profiles, and strategy
• Provide input and leadership to areas within areas of technical expertise

Education & Experience

• BS or advanced degree in life sciences, bioengineering, or related feels
• 3-10+ years experience related to the development, manufacture, and testing of cell and gene therapy products within a GMP environment; transferable experience in the manufacture of other biologics products will also be considered
• Experience in CMC project management, strategy, and budgeting
• Experience managing the  translation of development projects into manufacturing, regulatory submissions, and the generation of CMC IND/BLA content.

Other Skills & Abilities

• Excellent verbal and written communication skills with an ability to effectively interact with other technical professionals
• Good organizational skills and detail-oriented
• Ability to work independently and in a team environment
• Relevant computer skills and familiarity with common business software (Word, Excel, Project, Smartsheet)
• A plus, but not necessarily required:
  • Understanding of basic accounting concepts (revenue, expenses, cost of goods)
  • Familiarity with reading and interpreting legal agreements (e.g., confidentiality agreements, service agreements, quality agreements)

Salary and Benefits

Pluristyx supports employees with comprehensive healthcare and 401(k) plans. Salary will be commensurate with education, relevant work experience, and other qualifications. We are a small startup company in the heart of Seattle downtown on a rapid pace for growth. We work very closely together to support each other, and we recognize the importance of balance in life with flexibility in our work environment.

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