Senior Project Manager - Pharmaceutical; Remote

THIS IS NOT AN IT OR SYSTEMS POSITION. CANDIDATES MUST HAVE DRUG DEVELOPMENT KNOWLEDGE/EXPERIENCE

• 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 Teams conducting project scope 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, establish and lead regularly scheduled project status meetings, and communicate/escalate as needed in response to issues during project execution.
• Conduct risk assessment and identify key project challenges and issues in 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 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
• 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.
• Advanced in Microsoft Office:
  Word, Excel and Project required; experience with SharePoint and Team Site set-up and management is a plus

NO VISA SUPPORT IS OFFERED FOR THIS POSITION.