Senior Project Manager, Operations (Onsite)

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Senior Manager of Program Management will lead the Manufacturing Project Management Office (MPMO) supporting six manufacturing suites at ABC and driving the systems and program management personnel responsible for enabling manufacturing readiness activities, execution, and program sustainment. This includes actively managing incoming demand requests from Research & Development, In-licensing, Third-Party Manufacturing and Commercial portfolios, including new product introductions and product reintroductions that both support AbbVie's pipeline and our External Contract Manufacturing business partners. The Senior Manager provides project management leadership to ensure successful technical transfers and commercialization of the ABC Manufacturing Portfolio by integrating the efforts of all stakeholders including R&D, S&T, Quality, Production, Supply Chain, Engineering and Regulatory.

Responsibilities:

• Assemble and lead cross-functional teams comprised of Project Managers, and other integral stakeholders, responsible for driving readiness of manufacturing campaigns.
• Drive continuous improvement for the definition, communication, and standardization of product (re)introduction timelines and milestones, integrating the needs of process development, supply chain, engineering, quality, regulatory and production.
• Proactively identify and drive manufacturing and batch release related issues to closure by working with and elevating through appropriate functions to effectively troubleshoot and drive decisions.
• Understand project drivers, requirements, scenarios, and options. Proactively drives development of contingency and/or risk mitigation plans. Accountable for ensuring programs are robust from a technical, compliance and business perspective (i.e. regulatory requirements, Assurance of Supply).
• Effectively communicate and present project status to Operations senior management and stakeholders.
• Accountable for setting and achieving program and project plans and timelines that meet business and organizational objectives and ensure those plans are achieved.
• Proactively identify and drive technical and project plan related issues to closure by working with all relevant functional lines and facilitating the application of effective troubleshooting and/or decision-making methodologies, e.g. root cause analysis, decision tree analysis, DIA, etc.
• Evaluate risk, cost implications, regulatory path of scientific/quality/manufacturing alternatives and present to management and stakeholders for decision.
• Coordinate directly with AbbVie's External Contract Manufacturing team, if applicable, and internal site leadership on business related issues such as scope changes for existing contracts, and/or other requests made by third-party clients and/or internal CMC, global PMO or R&D stakeholders.
• Work with site leadership and other Technical Operations leaders to develop site strategic goals and manage to completion.

Qualifications

• Bachelors or Masters level degree in (bio)chemical engineering, life sciences, or other scientific related disciplines.
• 8+ years combined experience in positions related to process development, project management, engineering/process support, and manufacturing.
• Must have demonstrated organizational and planning skills, excellent verbal and written communication skills.
• Must be able to plan, sequence, schedule, monitor, control and execute project plans.
• Must be able to effectively facilitate the resolution of complex scientific, technical, analytical, and business issues across functional lines and/or with external clients.
• In-depth knowledge of Manufacturing Processes, QA, QC and Engineering
• Sound understanding of regulatory requirements to guide team and project

Additional Information

Applicable only to applicants