Biotech/Manufacturing Project Manager
Kamis Professional Staffing
Baltimore , MD 21201
Posted 3 weeks ago
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The Project Manager has total responsibility and accountability for the integration of the needs and requirements of the customer, QA, Regulatory, Manufacturing Operations and Engineering. The Project Manager leads the technical transfer of products by coordinating the execution of the transfer procedures, assisting production startup by communicating and negotiating client requirements, ensuring adherence to CGMPs and quality standards, and safeguarding company interests. The Project Manager coordinates all activities surrounding the ongoing manufacture of clinical and commercial products including, receipt of client supplied material, production control record generation, sample shipping, product shipping, invoicing and non-conformance resolution.
- Ensure the dissemination of the client requirements related * to the approved quote or supplier agreement within the company, * assigning and coordinating the tasks related to the introduction of * new processes/projects within the site.
- Coordination and control of the project progress, * including: continuous contact with clients, identification and * troubleshooting of technical problems, managing the project team * until the problems are resolved, production and QC assistance in the * project introduction initial phases, i.e.: analytical transfer, * installation feasibility studies, trials, batch validation.
- Develop project plans and timelines with input from all * required departments. Schedule and track project milestones and * deliverables using appropriate tools. Anticipate potential * project/program road blocks.
- Define project scope, goals and deliverables that support * business goals in collaboration with senior management and * stakeholders. *
- Responsible for the project budget.
- Identify and manage project dependencies and critical path.
- Lead project team meetings. *
- Host Company/Client meetings as required.
- Ensure that projects and deliverables meet various * requirements, e.g. from clients, regulatory, legal, etc.
- Lead continuous improvement efforts for clinical and * commercial products.
- Prepare and conduct presentations of technical information * within the department, across functional areas to clients, and to * senior management concerning specific projects/schedules.
Directly responsible for leading project teams consisting of other managers, supervisors and senior support staff in order to push products from introduction to manufacturing and commercialization. Responsible for the P&L for each project. Each project manager holds a client portfolio with oversight of ~20-30% of the revenue and associated profit for the site.
- Bachelors degree in science, engineering or business; * MBA highly desirable
- 5 years experience in Project Management in the BioTech or * Pharmaceutical Industry or in a Contract Manufacturing related * setting or equivalent suitable experience.
- Proficient in MS Project preferred
- PMP Certification