Job Title: Project Manager - Cell Therapy and Gene Therapy Manufacturing
Job Description

We are seeking a dedicated and experienced Project Manager to join our dynamic team focused on cell therapy and gene therapy manufacturing. In this role, you will collaborate closely with manufacturing and quality teams to ensure project timelines are accurately determined and met. You will also be responsible for communicating timelines to clients and managing the scope, schedule, and budget of assigned projects.

ResponsibilitiesCollaborate with manufacturing and quality teams to ensure accurate project timelines.Communicate timelines to clients effectively.Understand cell therapy and gene therapy manufacturing processes.Coordinate with internal manufacturing teams to maintain project timelines and deadlines.Understand project scope through collaboration with Sales and review of client services agreements.Assist in defining project scope and objectives, involving all stakeholders and ensuring technical feasibility.Monitor projects to ensure they are delivered on-time, within scope, and within budget.Manage changes to project scope, schedule, and budget using appropriate verification techniques.Assist in preparation and conducting of project kick-off meetings internally and with clients.Create client-facing documents including Gantt charts, project charters, communication plans, governance plans, and dashboards.Develop detailed project plans that ensure optimal quality and feasible schedules for all functional groups.Create and maintain a comprehensive project-related documentation depository.Create internal document reports, additional services requests, risk management, hour’s analysis, monthly production, and production forecast.Track project performance to analyze the successful completion of short and long-term goals.Meet budgetary objectives and adjust project constraints based on financial analysis.Analyze projects to identify risks and prepare risk mitigation strategies.Monitor projects on an ongoing basis, evaluating progress, quality, adherence to scope, timelines, and budget.Manage project resources efficiently and assist internal teams to accommodate all requests from project team members.Document all records of project issues and monitor alignment to project goals, identifying potential issues and assisting in resolution.Organize and facilitate meetings with internal and external project team members to achieve deliverables.Participate in weekly client meetings and monitor activities of internal team members as they relate to contract deliverables.Prepare status reports to internal stakeholders and clients as needed.Work with Project Manager to trend KPI metrics and communicate metric results and project summaries to executive management.Work with production planner to implement resourcing strategies for incoming projects and ensure workforce coverage.Continuously develop additional tools and refine processes to facilitate project performance.Coordinate schedule of additional activities related to the project as it progresses.Coordinate with other departments for understanding raw materials requirements, testing requirements, documentation requirements, validation and maintenance requirements, and scheduling.Build constructive and effective relationships with colleagues by solving problems and working through issues as a team.Perform other Project Management-related duties as assigned.Essential Skills2-3 years of experience with project management.2-3 years of experience within a CMO or a manufacturing environment.Experience coordinating with internal manufacturing teams to maintain project timelines and deadlines.Understanding of cell therapy and gene therapy manufacturing processes.Experience working within a manufacturing lab or clean room environment.Experience interfacing with internal teams for deadlines.Experience interfacing with other project managers to support manufacturing.Understanding of aseptic processes and GMP compliance.Ability to build quality into all aspects of work by maintaining compliance with all quality requirements.Ensure compliance with all FDA and Worldwide Quality & Compliance regulations as applicable.Additional Skills & QualificationsExperience in a Quality/Scientist role is preferred.Experience with project management tools and software.Strong communication and organizational skills.Ability to create and maintain comprehensive project documentation.Work Environment

This role requires interaction with all teams involved in manufacturing and quality, ensuring strict adherence to deadlines and understanding the needs of each team to meet client expectations. The work environment involves working within a manufacturing lab or clean room setting, maintaining high standards of compliance and quality, and participating in regular team meetings to track project progress and address any issues.

Pay and Benefits

The pay range for this position is $50.00 - $55.00

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Allendale,NJ.

Application Deadline

This position will be accepting applications until Jan 30, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.