CMC Project Manager

Artech Information System LLC; King of Prussia (PA); On-site; USD 95,000 - 120,000; Full time

Job summary

A leading staffing agency is seeking a CMC Project Manager in King of Prussia, PA. This role requires a deep understanding of pharmaceutical development and project management principles. The ideal candidate will coordinate with Project Teams to ensure projects meet timelines and compliance standards. Responsibilities include creating project plans, conducting health checks, and managing risks. A BSc in life sciences and experience in pharmaceuticals are crucial, along with knowledge of project management tools like PMP or PRINCE2.

Qualifications

• BSc with experience in development or manufacturing of pharmaceuticals.
• Knowledge of CMC and related technical packages.
• Demonstrated performance in project management.

Responsibilities

• Create and control accurate project plans.
• Conduct periodic health checks of project plans.
• Influence project development direction with data.

Skills

Project management

Pharmaceutical industry knowledge

Leadership

Cross-functional collaboration

Education

BSc in life sciences or related field

Tools

PMP

PRINCE2

Job description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

Job Title: CMC Project Manager

Location: King Of Prussia PA

Duration: 12 months

THIS IS NOT AN IT PM ROLE!!!!!

An understanding of all aspects of developing a pharmaceutical, the manufacturing requirements and some knowledge of the pharmaceutical industry, regulations and requirements are important in this role

This Project Manager role requires a scientific background with experience in the pharmaceutical industry as well as a deep understanding of the core principles of the discipline of project management.

This Project Manager role will align to non-clinical Platform Technology and Science (PTS) Project Teams that are composed of scientists accountable for the Safety, Disposition, Supply Chain and chemistry, manufacturing and controls (CMC) aspects of the drug development project.

The Project Manager needs a basic understanding of the safety, disposition and CMC work packages required to deliver a new medicine as well as a strong scientific background in at least one of these areas.

The role of project manager is critical in supporting the PTS Project Team, providing professional project management support to ensure project plans are designed and executed on behalf of project teams in line with planned time, cost and quality, and guiding teams through the initiation, planning, execution, monitoring and control and close out phases of the project, using the agreed Client standard of excellence in project management curriculum.

Key Responsibilities

• Create, monitor and control accurate and integrated project plans against which resource demand is realistically recorded and understood to enable decision making (e.g. establishes and manages budgets and resource for both outsourced and internal activities.
• Influence direction of project development utilizing data, scenario planning and insights to aid decision making.
• Work effectively at the interface with other Project Managers and Project Team Members to integrate PTS plans with the overarching Medicines Development Plan.
• Conduct periodic health checks of the PTS Project Plans to ensure quality of project planning and control.
• Provide credible data, insight and recommendations to enable cross portfolio reviews and to facilitate project and resource prioritization discussions.
• Ensure that a risk management plan is active and that is routinely discussed in the matrix team.
• Comply with all corporate governance requirements, such as project information documentation and retention and compliance training.
• Complete training and maintain competence against the project management curriculum including PMP or PRINCE2 certification. Maintain awareness of Project Management practice in the pharmaceutical and other industries.

Qualifications

A. Educational Background

List any academic or practical education that must be obtained to be qualified to perform this role.

1. Minimum Level of Education* BSc with experience in the development or manufacture of pharmaceuticals

Area of Specialisation* Life sciences, toxicology, DMPK, chemistry or bio/chemical engineering

2. Preferred Level of Education

• Knowledge and experience with the technical packages that are required to deliver a new medicine, whether from a toxicology background, disposition, or CMC.
• Ability to lead and influence matrix projects teams in the design and execution of project plans including utilization of resources (FTE and budget).
• A performance-driven individual, with a strong sense of urgency, exceptional organizational credibility, and deep understanding of the business.
• Demonstrated knowledge and application of skills in all relevant components of project management, including management of scope, time, cost, quality, integration, influence & negotiation, communications, risk, and scenario planning across all project management focus areas (initiating, planning, executing, monitoring and controlling, and closing GSK R&D projects).
• Practical experience in a previous project management role and, ideally, certification in PMP, APM or PRINCE2. Demonstrated ability in relevant soft skills including change management, continuous improvement, conflict resolution and consensus building.