Cell Therapy Development and Operations Senior Project Manager (CTDO Sr.PM) will influence and manage all aspects of initiating, planning, and executing complex, multi-disciplinary CTDO projects throughout the projects’ lifecycle.
As a certified PMP with a breadth of hands-on project management experience in the Pharma/Biotech/Cell Therapy regulated environments, the CTDO Sr.PM is expected to perform with minimal supervision and effectively facilitate the successful delivery of a wide process development and commercialization activities within the CTDO organization from initiation to completion while remaining aligned with company strategy, commitments and goals.
The primary focus of the CTDO Sr.PM will be to manage critical CTDO projects in support of specific product programs. The CTDO Sr.PM will work closely with functional leadership and representatives to ensure alignment and coordination across CTDO priorities.
The CTDO Sr.PM will be responsible for using PMO best practices, tools and templates. Ideally, the successful candidate will be proficient in the project management standards, processes, procedures.
Primary Responsibilities:
? Apply project management expertise across the portfolio for both standard and complex projects, managing multiple projects in parallel ? Utilize sound project management judgement ? Champion innovative project management tools and SDLC methodologies to support programs ? Drive project management and portfolio solutions across cell therapy technical operations team ? Define project scope / goals / deliverables / budget / timeline ? Prepare and present the business cases for the assigned projects to the Leadership Team ? Provide strong team leadership and drive to ensure projects are executed on time and within budget ? Create project plans and manage dependencies, milestones and deliverables ? Maintain project objectives throughout the project lifecycle ? Monitor execution and quality to customer / stakeholder / sponsor standards ? Identify, handle and resolve project-related issues and risks by developing specific action / risk mitigation / contingency plans and escalating early to upper level management when necessary ? Report on project progress, offer viable solutions and opportunities as they arise ? Implement appropriate project change control ? Ensure the project teams for the assigned projects are following the current standards, policies, procedures and guideline and bridge the gap for the CTDO project teams when needed ? Provide structure, leadership and if needed mentorship to team members to ensure team meets project objectives ? Manage internal and external resources and stakeholder to ensure the project schedule and budget are on track ? Manage vendors participating in the project including vendor selection, contracts and financials ? Develop and communicate status to PMO, project team, and CTDO leadership ? Partner with the project and workstream leads to successfully achieve project objectives ? Facilitate all project team meetings; attend related project team meetings as necessary to ensure alignment ? Evaluate and assess the project outcome
Competencies & Experiences:
? 5+ years of experience in GxP project management ? 5+ years of experience in CAR T / Cell Therapy or Biologics ? Understanding of GMP and FDA regulatory requirements correlating to biologics ? Bachelors/Masters degree in Life Sciences or technical field required ? Project Management Professional (PMP) certification ? Proficiency with related software tools such as: MS Project, OnePager, MS PPT, MS Excel, etc. ? Experience with sharepoint, Smart Sheets, ServiceNow, etc. ? Strong knowledge of biopharma industry. Familiarity/experience with end-to-end CMC drug development ? Solid analytical skills and financial acumen ? Proven record of successfully completing multi-million dollar projects ? Exceptional communication skills including ability to take an independent stance when interfacing with cross-functional stakeholders. Demonstrated focus on being able to translate data and metrics into predictable, value-add business insight ? Ability to work cross-functionally, with matrixed teams ? Excellent relationship-building skills including ability to foster productive, collaborative working relationships with business partners ? Strong leadership skills and executive presence with ability to positively influence outcomes ? Expertise in conflict resolution ? Excellent critical thinking and problem-solving skills ? Ability to think through and implement creative solutions ? Ability to promote the spirit of proactive, continuous quality improvement ? Willingness to do what needs to be done in a dynamic environment ? Demonstrated high degree of independence, requiring minimal supervision from senior management
Desired Qualifications:
? Highly-motivated, highly-organized, passionate self-starter: analytical, detail-oriented and operationally focused. ? Comfortable with uncertainty and meeting tight deadlines in the matrix 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.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
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.
