AustinPx Pharmaceutics and Manufacturing

Manage multiple pharmaceutical projects, ensuring scope, schedule, and budget adherence, and maintain stakeholder relationships. | Requires at least 5 years of project management experience in pharma, with knowledge of FDA regulations, GMP, and industry-specific project tools. | Essential Duties & Responsibilities 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 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, establish and 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. Competencies 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 Qualifications 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 a plus. NO VISA SUPPORT IS OFFERED FOR THIS POSITION.