[Hiring] Senior Project Manager @AustinPx Pharmaceutics and Manufacturing
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Role Description
ā¢ Collaborate with internal and external stakeholders to ensure projects remain in scope and meet budgetary scheduling and quality requirements.
ā¢ 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.
ā¢ Develop detailed project plans, ensure the dissemination of approved work scope to team members, oversee all aspects of projects, set deadlines, and assign responsibilities.
ā¢ Monitor and update project schedules using Microsoft Project, produce dashboards, and assess project health.
ā¢ Provide project management leadership to cross-functional Project Teams conducting project scopes of work.
ā¢ Responsible for client contract adherence; anticipate and proactively manage changes in project scope.
ā¢ Responsible for purchase order management, holding project team accountable for agreed upon deliverables, and escalating issues such as scope creep or roadblocks appropriately.
ā¢ 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.
ā¢ 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.
ā¢ 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.
ā¢ Provide regular program status reports to clients and Leadership Team that shall highlight key milestones, issues and/or risks, schedule, and costs.
ā¢ Forecast project revenue on a monthly, quarterly, and annual basis.
ā¢ Will be responsible for multiple programs and/or projects at any given time.
ā¢ Work with the project team to formulate recommendations for value-added services based on project objectives and regulatory requirements.
ā¢ Collaborate and communicate with Pharmaceutics/Operations to ensure appropriate material procurement activities occur and urgency is understood, determine plan for excess and obsolete material disposition.
ā¢ Collaborate and communicate with Operations to ensure appropriate generation of GMP documentation including batch records, specifications, etc.
ā¢ 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.
ā¢ Assist in training and act as a mentor to expanding project management team.
ā¢ May have other duties and responsibilities as required.
Qualifications
ā¢ Bachelor's degree in the life sciences, engineering, business and/or related discipline required.
ā¢ At least five (5) years project management in pharmaceutical industry required, CDMO experience highly preferred.
ā¢ Knowledge and experience of U.S. FDA Regulation 21 CFR Part 210, 211 and ISO 9001 is preferred.
ā¢ Advanced in Microsoft Office: Word, Excel and Project required; experience with SharePoint and Team Site set-up and management a plus.
Requirements
ā¢ Understand drug formulation, analytical method development, stability, and bulk drug manufacturing practices.
ā¢ Skilled in client relationship management.
ā¢ Positive attitude, self-motivator, strong attention to detail, excellent organizational and project management skills required.
ā¢ Strong interpersonal skills with the ability to negotiate with various stakeholders to reach consensus.
ā¢ Experience in conflict management and resolution is advantageous.
ā¢ Ability to communicate effectively with all levels of employees and management.
ā¢ Familiar with global drug development processes and clinical supplies life cycle.
ā¢ Knowledge of GCPs and clinical management would be advantageous.
Company Description
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Role Description
ā¢ Collaborate with internal and external stakeholders to ensure projects remain in scope and meet budgetary scheduling and quality requirements.
ā¢ 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.
ā¢ Develop detailed project plans, ensure the dissemination of approved work scope to team members, oversee all aspects of projects, set deadlines, and assign responsibilities.
ā¢ Monitor and update project schedules using Microsoft Project, produce dashboards, and assess project health.
ā¢ Provide project management leadership to cross-functional Project Teams conducting project scopes of work.
ā¢ Responsible for client contract adherence; anticipate and proactively manage changes in project scope.
ā¢ Responsible for purchase order management, holding project team accountable for agreed upon deliverables, and escalating issues such as scope creep or roadblocks appropriately.
ā¢ 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.
ā¢ 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.
ā¢ 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.
ā¢ Provide regular program status reports to clients and Leadership Team that shall highlight key milestones, issues and/or risks, schedule, and costs.
ā¢ Forecast project revenue on a monthly, quarterly, and annual basis.
ā¢ Will be responsible for multiple programs and/or projects at any given time.
ā¢ Work with the project team to formulate recommendations for value-added services based on project objectives and regulatory requirements.
ā¢ Collaborate and communicate with Pharmaceutics/Operations to ensure appropriate material procurement activities occur and urgency is understood, determine plan for excess and obsolete material disposition.
ā¢ Collaborate and communicate with Operations to ensure appropriate generation of GMP documentation including batch records, specifications, etc.
ā¢ 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.
ā¢ Assist in training and act as a mentor to expanding project management team.
ā¢ May have other duties and responsibilities as required.
Qualifications
ā¢ Bachelor's degree in the life sciences, engineering, business and/or related discipline required.
ā¢ At least five (5) years project management in pharmaceutical industry required, CDMO experience highly preferred.
ā¢ Knowledge and experience of U.S. FDA Regulation 21 CFR Part 210, 211 and ISO 9001 is preferred.
ā¢ Advanced in Microsoft Office: Word, Excel and Project required; experience with SharePoint and Team Site set-up and management a plus.
Requirements
ā¢ Understand drug formulation, analytical method development, stability, and bulk drug manufacturing practices.
ā¢ Skilled in client relationship management.
ā¢ Positive attitude, self-motivator, strong attention to detail, excellent organizational and project management skills required.
ā¢ Strong interpersonal skills with the ability to negotiate with various stakeholders to reach consensus.
ā¢ Experience in conflict management and resolution is advantageous.
ā¢ Ability to communicate effectively with all levels of employees and management.
ā¢ Familiar with global drug development processes and clinical supplies life cycle.
ā¢ Knowledge of GCPs and clinical management would be advantageous.
Company Description
Apply tot his job
Apply To this Job