Senior Manager – Project Management New Product Line Manufacturing – Labeling

Senior Manager – Project Management New Product Line Manufacturing – Labeling

Requirements

• Bachelor’s Degree and Eight Years’ Experience
• Masters’ Degree and Six Years’ Experience
• Ph.D.

Responsibilities

• Lead and manage multiple, concurrent clinical and commercial NPI projects impacting the inspection and packaging areas and equipment.
• Define and understand product transfer scope, timelines, and demands from PNGC or PPSC endorsement through manufacturing and release, coordinating resources from the La Verne site to meet objectives.
• Ensure product transfer team can deliver products to meet compliance with regulatory requirements, Current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), Safety regulations, and other relevant standards.
• Facilitate necessary gap assessment with the SMEs from La Verne or from the global sites.
• Develop comprehensive work plans for each product transfer in collaboration with cross-functional teams, including Technical Services, Packaging, Quality Assurance (QA), Quality Control (QC), Validation, Supply Chain, Regulatory/CMC, EHS, Finance, IT, and Engineering.
• Oversee and manage daily workflow of the project team, ensuring that milestones are met and any potential risks or delays are proactively addressed.
• Track the status and completion of critical tasks, such as procurement, documentation, and studies, to ensure milestones are achieved. Escalate issues when necessary to ensure timely resolution.
• Utilize knowledge in inspection and packaging processes and equipment to provide guidance and support for global, cross-functional discussions, ensuring alignment of decisions to meet project objectives.
• Represent the La Verne cross-functional team in NPI-focused meetings with corporate stakeholders, facilitating communication and bridging any gaps in understanding between corporate and site personnel.
• Lead regular project review meetings with cross-functional representatives, ensuring projects are on track and addressing any deviations promptly.
• Provide regular and timely updates to senior management on the status of NPI projects, including upcoming, ongoing, and completed initiatives. Collaborate with senior leadership for key decision-making.
• Tackle moderately complex problems by applying creative problem-solving techniques and offering innovative recommendations to drive project success.
• Exercise sound judgment in selecting appropriate methods, techniques, and evaluation criteria to achieve project goals while adhering to defined practices and policies.
• Provide tactical guidance and management to the project team, ensuring alignment with broader Packaging Operations objectives and strategies.
• Contribute to the development and implementation of standardized procedures and processes to ensure consistency in Packaging Project Management. Play a key role in the creation of new concepts, techniques, and operational standards.

Preferred Qualifications

• 8+ years of relevant experience in pharmaceutical industry with a focus on inspection/packaging and a sciences BS/BA degree.
• 6+ years of relevant experience in pharmaceutical industry with a focus on inspection/packaging and a MS, MA or MBA.
• 3+ years successfully serving as a project manager.
• Proven experience in managing complex NPI or technology transfer projects.
• Knowledge of cGMPs, GLPs, and regulatory requirements in a manufacturing setting.
• Demonstrated leadership ability in cross-functional teams, including Technical Services, Manufacturing/Packaging, QA, QC, Validation, Supply Chain, and Engineering.
• Excellent communication skills, with experience interfacing with senior management and cross-functional global teams.
• Strong problem-solving and decision-making skills, with a focus on driving project success in a fast-paced environment.
• Proficient in Microsoft Office applications.