Job Description

Project Manager II (Scientific)
Cambridge, MA
12 Months extendable contract
Pay Range: $50-60/hr on w2

Job Description
Open to candidates willing to relocate at their own expense Some Hybrid work may be offered, however onsite work required 2-3 days per week ? 10% Minimal travel may be required to Bridgewater NJ, if so reimbursement would be offered The role will with within the department that supports Manufacturing supply for Production of drug substances. Managing all activities, troubleshooting Experience with project Management Software, Microsoft Project Must-Have: At least 7+ years' experience within Pharmaceutical Industry: specific to technical project management, pharmaceutical development, technical operations and/or manufacturing of various drug product dosage forms. Must have prior experience as a project manager of technical projects with demonstrated ability to facilitate multi-disciplined teams. Writing Skills: be able to clearly communicate a message and provide data and information requested Team Player Flexible / Problem Solving / Solution focused Being able to reliably clarify of communicate and ability to circumvent and address issues. Communicate information and concise Nice to Have: Master's degree MBA Plus Quality and/or Regulatory background is also highly desirable. Knowledge of the French language (speak, read, and/or write) a plus.

The overall scope of this position is the Project Management of CClient development, and Pharmaceutical Technical activities in support of new R&D compounds, Life Cycle Management Programs (LCM), product territory extensions and Industrial technical projects. The position is responsible for coordination of technical aspects of Manufacturing Science Analytical Technologies (MSAT) and Manufacturing and Supply (M&S) Programs through organization and alignment with other group divisions (Commercial Global Business Units, R&D, Regulatory, Alliance Management, etc.), various internal support laboratories and contract CMO facilities. The Project Manager plans and follows activities as defined by the MSAT Project Leaders / Program Directors project teams to: creating project scope documents to gain sponsor and management agreement; creation and maintenance of detailed plans, organizing meetings; reporting actions and follow-up for delivery; Technically maintain product portfolio, support development of new product/line extensions, and support site-to-site process transfer and process upgrade activities for new and existing products.
Additionally, as new products approach the registration / launch stage, the Project Manager, working closely with: MSAT CClient Leader, M&S Sites, Supply Chain, CMO's (with External Manufacturing) and Alliance Partners to outline plans and activities.

Key Duties and Responsibilities
Supports MSAT Program Directors and CClient Leaders with planning, coordinating and following activities for the various types of projects outlined above, organizing meetings and preparing project updates for project teams and IA management. Specific duties and responsibilities include, but not limited to:
Creating project scope documents to gain sponsor and management approval.
Creating and maintaining detailed timelines and project plans with input from Program Directors / CClient Leaders.
Organizing meetings with project teams for status update and action item follow up to ensure adherence to timelines.
Organizing meetings with sponsors (R&D, GBU, M&S Teams) to communicate project updates.
Conducting risk assessments for project activities and outlining contingency plans.
Creates and maintains detailed project plans with gating / milestones
Prepares summaries of proposals from CMOs/CROs for projects and presents to management for review.
Obtains the necessary technical information to support projects at internal sites or CMO/CROs.
Assists with reviewing and finalizing technical documents such as protocols, reports and regulatory dossier content.
Assists with reviewing contracts (such as CDSs, MSAs, Quality Agreements) and quotations to support CClient development projects, Industrial technical projects and internal Industrial Development programs.
May require occasional travel to other sites or suppliers.

Skills
BS/MS in chemistry, pharmacy or science with strong experience in Pharmaceutical development, technical operations and /or manufacturing. MB plus.
Proficiency in MS Office
Knowledge of project management software
Solid writing and presentation skills
Excellent organizational and communication skills.

Basic requirements
At least 7+ years' experience in technical project management, pharmaceutical development, technical operations and/or manufacturing of various drug product dosage forms. Must have prior experience as a project manager of technical projects with demonstrated ability to facilitate multi-disciplined teams.
Experience with international project teams a plus.
Quality and/or Regulatory background also highly desirable.
Knowledge of French language (speak, read and/or write) a plus.