ClinLab Staffing

Project Manager—Glen Rock, PA

Essential Functions: Acts as a liaison between all interested parties for developmental and commercial projects, assures the timely completion of project activities, deliverables and shipments.

Project Execution

• Manages project team expectations and communications, hosting internal and external meetings, and provides timely agenda and meetings notes. Clearly communicates with team members to assure project needs, action items, and responsibilities are articulated and understood; monitors and facilitates progress; identifies and communicates project risks.
• Manages projects timelines, cost, business, and quality objectives for projects; communicates with management on a regular basis regarding status and timing of projects.
• Assures project plans, templates, and design records are assembled, complete, and kept up-to-date with Product Development Process, accurately representing project history & status. Makes continuous improvement recommendations and supports changes to Product Development Process.
• Monitor project performance using appropriate tools and metrics and prepare status reports for internal and external stakeholders.
• Identifies critical commercial program issues and drives open action items to resolution, with excellent communication skills, ensuring the best interests of all interested parties.

• Participate in technical scoping calls with clients and Business Development to define requirements, assess feasibility, and support Work Plan generation
• Translate client needs into preliminary project plans including timelines, resource needs, and technical assumptions to support quoting.
• Collaborate with internal subject matter experts (e.g., Process Development, Analytical, QA, Manufacturing) to gather inputs for quote development
• Assist in reviewing and refining quotations and proposals to ensure alignment with client expectations, regulatory requirements, and operational capabilities.
• Maintain documentation and knowledge transfer from proposal stage through project initiation to ensure seamless handoff and execution.
• Gathers scope of work for Work Plan activities against Product Development Process for ongoing projects where the project scope has changed from the original Work Plan. Prepares, coordinates and maintains record of Work Plans, quotations, and exhibits.

• Manages the initiation and closure of deliverables and shipments, ensuring on time completion. Receives Purchase Orders to start and performs invoicing functions upon completion.
• Enters all purchase orders into Oracle EBS system; reviews and verifies accuracy of pricing information against Supply Agreement or Work Plan. Confirms orders placed in accordance with Terms of Work or Supply Agreement.
• Manages invoicing and monitors receivables (coordinating with Finance & Administration Functions). Communicates forecasted revenue to upper level management.
• Additional Responsibilities:
• Assist in other project management initiatives, or other activities as requested.
• Follows all Regulatory requirements and procedures (FDA, DEA, et al) specified for the position and/or project.
• Participates in and provides input to 6S/Lean or other operational initiatives.
• Works with other functional units to ensure identification of and compliance with best practices across project management, pharmaceutical development, and business functions.
• Applies company policies, ensures good housekeeping, and enforces safety regulations.
• Performs other duties and responsibilities as assigned.

• At least 3-5 years of project management, account management, pharmaceutical development, or manufacturing experience preferred. Bachelor’s degree required with a degree in science, or engineering related field preferred.
• Project Management Professional certification required. Can be obtained within one year after hire (company paid). If not currently certified, familiarity with standard project management and scheduling concepts, programs, practices, and procedures required.
• Ability to learn processes and technologies in order to use and speak intelligently about them. Ability to use this knowledge to manage all projects and assignments to successful conclusion.
• Experience in a regulated field. Pharmaceutical experience is preferred.
• Ability to comprehend and conform to Quality Systems, cGMPs, and DEA requirements.
• Strict adherence to corporate, customer, and other confidentiality agreements and similar documents.
• Functioning capability with standard office software, including, but not limited to, Microsoft Word, Excel, Teams, and PowerPoint. Ability to learn Oracle EBS as required to successfully execute all job functions.
• Ability to work independently with minimal supervision.
• Strong oral and written communication with an emphasis on strong interpersonal skills including influence management skills.
• Ability to professionally present and speak before crowds.
• Ability to accurately gather, assemble, calculate, analyze, and/or report financial information.
• Problem-solving and critical-thinking capabilities, particularly in managing and executing multiple, competing priorities.
• Capable of simultaneously managing a variety of complex projects and tasks with a certain degree of creativity and latitude to drive them to timely and successful conclusion.
• Ability to travel as required.