Senior CMC Project Manager

Spectraforce

Seattle, Washington


19 days ago

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Senior CMC Project Manager
Spectraforce
Seattle, Washington

19 days ago

Job Description

Position: Senior CMC Project Manager
Location: Seattle, WA, 98109 (Hybrid)
Duration: 12 Months

Top Skills:

• 5+ years’ experience in bio tech/life sciences project management; cell Therapy experience preferred.
• Bachelor’s degree in STEM/Life Sciences-related discipline.
• Project management qualification preferred
• Proficiency with related software tools such as: MS Project, Office Timeline Pro, Smartsheet, MS PPT, MS Excel, SharePoint, etc.
• Strong knowledge of biopharma industry. Familiarity/experience with end-to-end CMC drug development.
• Familiarity with alliance management

Job Description

The Technical Project Manager (PM) will be a key member of the Cell Therapy Development (CTD) Development Operations & Services (DO&S) Portfolio Management Office. This individual will be responsible for overseeing the planning, execution, and delivery of project(s) in alignment with the company's strategy, commitments, and goals. The project(s) will be technical in nature and will support an individual product program or the development portfolio as a whole, with a particular focus on Drug Product Process Development support and alliance management.

The Technical PM will work with stakeholders to identify project scope and strategy, develop detailed project plans, and collaborate with functional leads and project managers to coordinate project deliverables. The Technical PM will manage project timelines, risks, budgets, and resources, communicate project status, and be accountable for project outcomes. They will use CTD DO&S PMO best practices, tools, and templates, and work with internal and external partners to implement effective project management plans. The ideal candidate will be a demonstrated leader with cross-functional experience, able to work under tight deadlines with world-class partners, suppliers, and business leaders.

Primary Responsibilities:
• Partner with project, functional, and work stream leads to successfully achieve project objectives inclusive of program assets as well as strategic initiatives.
• Apply project management expertise across the portfolio for standard and complex projects, managing one project in detail.
• Provide strong team leadership and drive to ensure projects are executed on-time and within budget.
• Facilitate the definition of project scope, goals, and deliverables.
• Create project plans; scope, work, resources, scheduling, etc.
• Maintain project objectives throughout the project lifecycle.
• Monitor execution and quality of alliance partner to customer/stakeholder/sponsor standards.
• Identify and resolve issues and risks.
• Report on project progress, offering viable solutions and opportunities as they arise.
• Implement appropriate project change control.
• Facilitate all project team meetings; attend related project meetings as necessary to ensure alignment.
• Evaluate and assess the results of the project through regular after-action reviews.
• Provide structure and leadership across departments to ensure the team meets project objectives.
• Work with internal and external stakeholders to manage project deliverables, e.g., CMO’s, Supply Chain, etc.
• Develop and communicate status to organizational leadership.

CMC Support and Sub-Team Management Responsibilities:
• Lead and coordinate Drug Product Process Development and related CMC sub-teams to ensure alignment with overall project goals and timelines.
• Collaborate closely with CMC functional areas, including process development, analytical development, quality, and regulatory, to support project objectives.
• Develop and maintain detailed CMC project plans, including resource allocation, risk management, and timeline tracking.
• Facilitate cross-functional CMC sub-team meetings to ensure alignment and address any CMC-related issues or risks.
• Monitor and report on the progress of Drug Product Process Development activities, ensuring that all milestones are met and any deviations are promptly addressed.
• Ensure clear communication and collaboration across all involved teams.
• Ensure compliance with regulatory requirements and industry standards in all CMC activities.
• The ideal candidate will have a strong background in project management and CMC support, with the ability to lead cross-functional teams and manage complex projects in a dynamic environment.

Competencies & Experiences
• 5+ years’ experience in bio tech/life sciences project management; cell Therapy experience preferred.
• Bachelor’s degree in STEM/Life Sciences-related discipline.
• Project management qualification preferred
• Proficiency with related software tools such as: MS Project, Office Timeline Pro, Smartsheet, MS PPT, MS Excel, SharePoint, etc.
• Strong knowledge of biopharma industry. Familiarity/experience with end-to-end CMC drug development.
• Familiarity with alliance management
• Excellent interpersonal, communication, and presentation skills.
• Ability to work cross-functionally, with matrixed teams; maintaining strong business partner relationships.
• Strong leadership skills and executive presence; ability to positively influence outcomes.
• Expertise in conflict resolution.
• Excellent critical thinking and problem-solving skills.
• Willingness to do what needs to be done in a dynamic environment. 

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $80.00/hr.

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