Process Improvement Project Manager - Pharma

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Title: Project Manager – Operational Excellence (Pharmaceutical Manufacturing)

• Job Location: Los Angeles, CA
• Work Model: 100% onsite
• Schedule: Monday – Friday, with flexibility to support 24/7 mfg operations

Description:
We are seeking an experienced Project Manager – Operational Excellence to lead technical and operational improvement projects within a regulated pharmaceutical manufacturing environment.
This role is ideal for a project management professional with a strong background in GMP manufacturing, process improvement, equipment qualification, validation, and change control.

The Project Manager will oversee multiple projects supporting manufacturing capacity, equipment reliability, operational efficiency, and regulatory compliance. Working closely with Engineering, Manufacturing, Quality, Validation, and other technical teams, this individual will drive projects from initial planning through successful implementation and closure.

Key Responsibilities

• Lead and manage multiple pharmaceutical manufacturing projects, ranging from process improvements to large-scale plant initiatives.
• Develop and maintain project plans, schedules, milestones, resource allocations, and deliverables.
• Manage projects through initiation, planning, execution, implementation, and closure.
• Drive initiatives focused on manufacturing capacity expansion, equipment reliability, process optimization, and quality improvements.
• Identify project risks, develop mitigation strategies, and proactively resolve obstacles impacting schedules or deliverables.
• Coordinate cross-functional teams, including Manufacturing, Engineering, Quality Assurance, Quality Control, Validation, Facilities, and Maintenance.
• Oversee GMP change control activities, ensuring timely approvals, implementation, and closure.
• Support equipment qualification, validation, and regulatory compliance activities.
• Prepare technical documentation, project status reports, risk assessments, and presentations for stakeholders.
• Facilitate project meetings, establish clear responsibilities, and maintain alignment across technical teams.
• Support continuous improvement initiatives and the standardization of project management processes and procedures.
• Ensure completed projects transition effectively into routine manufacturing operations.

Required Qualifications

• Bachelor's degree in Engineering, Biology, Chemistry, Biochemistry, or a closely related scientific or technical discipline.
• Minimum 5 years of experience in the pharmaceutical industry, including at least 3 years managing projects in a GMP manufacturing environment.
• Demonstrated experience managing technical projects involving pharmaceutical manufacturing processes, facilities, or equipment.
• Knowledge of pharmaceutical manufacturing systems and equipment, such as chromatography, ultrafiltration, Clean-in-Place (CIP) systems, reactor tanks, centrifuges, or similar technologies.
• Strong understanding of cGMP requirements, FDA regulations, validation, equipment qualification, and change control.
• Proven ability to manage project scope, schedules, resources, risks, and competing priorities.
• Experience leading cross-functional technical teams and coordinating projects across multiple departments.
• Strong technical writing, documentation, communication, and problem-solving skills.
• Ability to work independently, exercise sound judgment, and deliver results in a fast-paced manufacturing environment.
• Flexibility to accommodate operational needs within a 24/7 manufacturing facility.

Preferred Qualifications

• Project Management Professional (PMP) certification or formal project management training.
• Experience in biologics, biopharmaceutical, or other complex pharmaceutical manufacturing environments.
• Background in manufacturing engineering, technical operations, validation, or process engineering.
• Experience managing equipment installations, manufacturing capacity expansions, facility upgrades, or process improvement initiatives.
• Familiarity with Lean Six Sigma, continuous improvement methodologies, or PMO governance.

Additional Information

• Schedule: Flexibility required to support a 24/7 manufacturing operation.
• Travel: Occasional domestic travel may be required.