Pharma / GXP Project Manager

W2 ONLY - Project Manager - No Sponsorship Available

Hillsboro. Oregon

Description

As a Senior Project Manager, you will be part of the Hillsboro Innovative Therapies (HIT) Project Management team in the newly formed Pharma Technical Cell and Gene Therapy organization (PTC). This growing organization is working with groups, partners and contract manufacturing organizations to establish capabilities for new cell and gene therapy products

Plus: Experience within the Pharmaceutical and BioTech industry

Plus: Experience managing IT projects in GxP validated environments

Plus: Experience managing offshore contract resources Plus: Experience with ERP, LIMS and PKM systems

Day Shift-8:00am to 4:30 PM, Onsite position - possibility for hybrid

Contract duration: 12/31/2027

This Senior Project Manager role will provide organizational support, leadership, project management and business operations expertise to HIT. Additionally, this position must effectively manage the projects across global locations and time zones and be able to travel internationally as needed. Areas of focus include: Project management of application or infrastructure projects that are of high complexity and risk.
Accountability for the successful implementation of technical solutions through effective project controls, planning and execution throughout all phases of our project management methodology
Responsibility for managing assigned resources, effectively tracking and reporting budgets and financial forecasts, creating and tracking detailed project plans,
Facilitating project meetings as well as proactively controlling project scope, risks and issues.

The successful candidate will ensure project execution and alignment with the overall business model and is accountable for the successful implementation of technical solutions through effective project controls, planning and execution throughout all phases of our project management methodology.

The HIT and PTC (Pharma Technical Cell & Gene Therapy) organization is highly matrixed and cross functional, requiring an individual with outstanding leadership, collaboration, communication, negotiation, facilitation and influencing skills. Job Responsibilities Effectively manage projects: define project objectives, requirements, and assumptions necessary to develop project charter and project plans.
Identify, acquire, and lead multifunctional, global project teams (project team sizes 15-60)
Manage relationships with various technology and business communities to achieve project objectives
Plan and manage the project scope, schedule, and budget to fulfill objectives and satisfy project requirements and strategy.
Develop, drive and maintain integrated project plans, and timelines aligning project tactics with project strategy.
Lead, coordinate, facilitate, and motivate all associated project resources to gain alignment on project goals and deliverables.
Facilitate and lead effective project meetings and workshops, manage change and conflict, and develop resource planning estimates to manage project workload and productivity. Create agenda topics and facilitate project/team meetings; writes/reviews meeting minutes.
Implement lean project and portfolio management practices.
Apply strong project management and business operations skills and experience in the creation, maintenance and improvement of business processes and tools to support the PTC organization.
Support creation and maintenance of portfolio reports to facilitate communication and alignment across workstreams. Support team business processes and tools, ensuring timely updates and driving continuous improvement.
Identify and apply systematic quality activities to ensure that projects employ all processes needed to meet Computer System Validation directives
Design and implement improvements where necessary / appropriate to improve operational efficiencies
Lead and conduct risk management planning, identification, analysis and monitoring on projects within project teams, ensuring risks have appropriate mitigation and contingency plans.
Formulate risk mitigation strategies and recommend solutions
Manage the processes required to ensure timely and appropriate generation, collection, distribution, storage, retrieval, and ultimate disposition of project information and documentation necessary for successful communications across all stakeholders and any required updates to living system documents for validated systems

Qualifications:
BA/BS with a minimum of 5-8 years of Pharmaceutical Biotech project management experience in the Pharmaceutical/Biotech or Informatics / IT industry.

Prefer 10-12 years overall project management experience

PMP certification or certification in-progress preferred

Experience supporting technical development and transfer activities with a focus on cell and gene therapy preferred.

Ideal candidate has previous experience working with external collaborators

Excellent PowerPoint, collaboration systems and g-suite skills (or similar).

Experience with MS Project or Smartsheet and data visualization tools (e.g. Tableau or Spotfire) is required.

Excellent written and verbal skills.

Demonstrates effective communication skills and integrates team members, internal and external partners to achieve team goals.

Must be proactive, with excellent interpersonal skills and ability to work collaboratively and flexibly in multiple teams.

Ability to work in a dynamic, matrixed team environment and effectively manage change.

Willing to travel up to 10% of time (future)

7+ years of experience as a successful Information Technology Project Manager using structured project management processes

Deep understanding of various SDLCs (Waterfall, Agile, iterative, etc.)
Deep understanding of technology infrastructures
Demonstrated competency planning and tracking project schedules with clearly-defined critical paths
Ability to manage mid-level, multifunctional projects across multiple global locations
Proven ability to obtain results in a global, matrix environment
Track record of delivering projects on time and on budget
Ability to see the interrelationship of a project across "the big picture" and understand its dependency on other projects in the program as required
Excellent oral and written communication skills, as well as presentation abilities
Demonstrated success communicating across a variety of audiences, including business people and technologists (both up and down the organization)
Exceptional listening, problem solving, negotiation, and facilitation skills
Proven leadership abilities and emotional intelligence
Demonstrated success handling initiatives of significant complexity and risk

Plus: Experience within the Pharmaceutical and BioTech industry
Plus: Experience managing IT projects in GxP validated environments
Plus: Experience managing offshore contract resources
Plus: Experience with ERP, LIMS and PKM systems

W2 ONLY - Project Manager - No Sponsorship Available

Hillsboro. Oregon

Description

As a Senior Project Manager, you will be part of the Hillsboro Innovative Therapies (HIT) Project Management team in the newly formed Pharma Technical Cell and Gene Therapy organization (PTC). This growing organization is working with groups, partners and contract manufacturing organizations to establish capabilities for new cell and gene therapy products

Plus: Experience within the Pharmaceutical and BioTech industry

Plus: Experience managing IT projects in GxP validated environments

Plus: Experience managing offshore contract resources Plus: Experience with ERP, LIMS and PKM systems

Day Shift-8:00am to 4:30 PM, Onsite position - possibility for hybrid

Contract duration: 12/31/2027

This Senior Project Manager role will provide organizational support, leadership, project management and business operations expertise to HIT. Additionally, this position must effectively manage the projects across global locations and time zones and be able to travel internationally as needed. Areas of focus include: Project management of application or infrastructure projects that are of high complexity and risk.
Accountability for the successful implementation of technical solutions through effective project controls, planning and execution throughout all phases of our project management methodology
Responsibility for managing assigned resources, effectively tracking and reporting budgets and financial forecasts, creating and tracking detailed project plans,
Facilitating project meetings as well as proactively controlling project scope, risks and issues.

The successful candidate will ensure project execution and alignment with the overall business model and is accountable for the successful implementation of technical solutions through effective project controls, planning and execution throughout all phases of our project management methodology.

The HIT and PTC (Pharma Technical Cell & Gene Therapy) organization is highly matrixed and cross functional, requiring an individual with outstanding leadership, collaboration, communication, negotiation, facilitation and influencing skills. Job Responsibilities Effectively manage projects: define project objectives, requirements, and assumptions necessary to develop project charter and project plans.
Identify, acquire, and lead multifunctional, global project teams (project team sizes 15-60)
Manage relationships with various technology and business communities to achieve project objectives
Plan and manage the project scope, schedule, and budget to fulfill objectives and satisfy project requirements and strategy.
Develop, drive and maintain integrated project plans, and timelines aligning project tactics with project strategy.
Lead, coordinate, facilitate, and motivate all associated project resources to gain alignment on project goals and deliverables.
Facilitate and lead effective project meetings and workshops, manage change and conflict, and develop resource planning estimates to manage project workload and productivity. Create agenda topics and facilitate project/team meetings; writes/reviews meeting minutes.
Implement lean project and portfolio management practices.
Apply strong project management and business operations skills and experience in the creation, maintenance and improvement of business processes and tools to support the PTC organization.
Support creation and maintenance of portfolio reports to facilitate communication and alignment across workstreams. Support team business processes and tools, ensuring timely updates and driving continuous improvement.
Identify and apply systematic quality activities to ensure that projects employ all processes needed to meet Computer System Validation directives
Design and implement improvements where necessary / appropriate to improve operational efficiencies
Lead and conduct risk management planning, identification, analysis and monitoring on projects within project teams, ensuring risks have appropriate mitigation and contingency plans.
Formulate risk mitigation strategies and recommend solutions
Manage the processes required to ensure timely and appropriate generation, collection, distribution, storage, retrieval, and ultimate disposition of project information and documentation necessary for successful communications across all stakeholders and any required updates to living system documents for validated systems

Qualifications:
BA/BS with a minimum of 5-8 years of Pharmaceutical Biotech project management experience in the Pharmaceutical/Biotech or Informatics / IT industry.

Prefer 10-12 years overall project management experience

PMP certification or certification in-progress preferred

Experience supporting technical development and transfer activities with a focus on cell and gene therapy preferred.

Ideal candidate has previous experience working with external collaborators

Excellent PowerPoint, collaboration systems and g-suite skills (or similar).

Experience with MS Project or Smartsheet and data visualization tools (e.g. Tableau or Spotfire) is required.

Excellent written and verbal skills.

Demonstrates effective communication skills and integrates team members, internal and external partners to achieve team goals.

Must be proactive, with excellent interpersonal skills and ability to work collaboratively and flexibly in multiple teams.

Ability to work in a dynamic, matrixed team environment and effectively manage change.

Willing to travel up to 10% of time (future)

7+ years of experience as a successful Information Technology Project Manager using structured project management processes

Deep understanding of various SDLCs (Waterfall, Agile, iterative, etc.)
Deep understanding of technology infrastructures
Demonstrated competency planning and tracking project schedules with clearly-defined critical paths
Ability to manage mid-level, multifunctional projects across multiple global locations
Proven ability to obtain results in a global, matrix environment
Track record of delivering projects on time and on budget
Ability to see the interrelationship of a project across "the big picture" and understand its dependency on other projects in the program as required
Excellent oral and written communication skills, as well as presentation abilities
Demonstrated success communicating across a variety of audiences, including business people and technologists (both up and down the organization)
Exceptional listening, problem solving, negotiation, and facilitation skills
Proven leadership abilities and emotional intelligence
Demonstrated success handling initiatives of significant complexity and risk

Plus: Experience within the Pharmaceutical and BioTech industry
Plus: Experience managing IT projects in GxP validated environments
Plus: Experience managing offshore contract resources
Plus: Experience with ERP, LIMS and PKM systems