Senior Project Manager - Pharmaceutical (Remote)

• Collaborate with internal and external stakeholders and ensure projects remain in scope and meet budgetary scheduling and quality requirements.

• Primary point-of-contact for client programs assigned; responsible for building and maintaining quality relationships with key stakeholders resulting in valued and trusted relationships, client satisfaction and continued strategic business opportunities.

• Develop detailed project plans,ensure the dissemination of approved work scope to team members, oversee all aspects of projects, set deadlines, and assign responsibilities.

• Monitor and update project schedules using Microsoft Project, produce dashboards, and assess project health. 

• Provide project management leadership to cross-functional Project Teamsconducting project scopes of work.

• Responsible for client contract adherence; anticipate and proactively manage changes in project scope.

• Responsible for purchase order management, holding project team accountable for agreed upon deliverables, and escalating issues such as scope creep or roadblocks appropriately.

• Develop communication plans for defining communication channels between internal and external stakeholders, establishand lead regularly scheduled project status meetings, and communicate/escalate as needed in response to issues as they arise during project execution.

• Conduct risk assessment and identify key project challenges and issues within a timely manner and determine effective resolution through cross functional collaboration; recommend appropriate mitigations.

• Collaborate with supervisor and Leadership Team to ensure all activities defined herein, meet or exceed clients' expectations, including the establishment and monitoring of project budgets.

• Provide regular program status reports to clients and Leadership Team that shall highlight key milestones, issues and/or risks, schedule, and costs.

• Forecast project revenue on a monthly, quarterly and annual basis.

• Will be responsible for multiple programs and/or projects at any given time.

• Work with the project team to formulate recommendations for value added services based on project objectives and regulatory requirements.

• Collaborate and communicate with Pharmaceutics/Operations to ensure 1) appropriate material procurement activities occur and urgency is understood, 2) determine plan for excess and obsolete material disposition

• Collaborate and communicate with Operations to ensure appropriate generation of GMP documentation including batch records, specifications, etc.

• Collaborate and communicate with the Analytical Laboratory to ensure necessary client testing is developed, validated/verified, specifications are generated and product is tested per a mutually-defined timeline.

• Assist in training and act as a mentor to expanding project management team. 

• May have other duties and responsibilities as required.

• Understand drug formulation, analytical method development, stability, and bulk drug manufacturing practices

• Skilled in client relationship management.

• Positive attitude, self-motivator, strong attention to detail, excellent organizational and project management skills required.

• Strong interpersonal skills with the ability to negotiate with various stakeholders to reach consensus.

• Experience in conflict management and resolution is advantageous.

• Ability to communicate effectively with all levels of employees and management.

• Familiar with global drug development processes and clinical supplies life cycle

• Knowledge of GCPs and clinical management would be advantageous

• Bachelor's degree in the life sciences, engineering, business and/or related discipline required

• At least five (5) years project management in pharmaceutical industry required, CDMO experience highly preferred
• Knowledge and experience of U.S. FDA Regulation 21 CFR Part 210, 211 and ISO 9001 is preferred.

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