Program Manager, MES

AbbVie Inc.; Irvine (CA); Vor Ort; USD 140.000 - 190.000; Vollzeit

Zusammenfassung

AbbVie Inc. in Irvine, CA seeks a Program Manager, MES to organize and lead cross-functional teams across R&D, S&T, Quality, Supply Chain, and Regulatory for manufacturing tech transfers and commercialization.

You will own budgets, timelines, and risk plans, driving site transfers, lifecycle projects, and multi-site execution to ensure product readiness and supply continuity. The role requires 10+ years in process development and project management, with strong GMP and regulatory knowledge, and

Qualifikationen

• Bachelor’s degree in engineering, science, or related discipline, or equivalent technical experience.
• 10+ years of combined experience in process development, project management, engineering/process support and manufacturing.
• Strong knowledge of GMP Manufacturing, Supply Chain, Validation, Engineering, CMC and pharmaceutical regulations.
• Excellent organizational, planning, verbal and written communication skills.
• Demonstrated project management skills with successful delivery of projects.
• Plant experience is a must; PMP certification or multilingual abilities are a plus.

Aufgaben

• Assemble and lead cross-functional teams across science, engineering, QA, and operations for process development and manufacturing.
• Lead site transfers, lifecycle projects, and new indications/presentations on time and within budget.
• Identify and drive issues to resolution with functional lines; troubleshoot and decide.
• Manage multiple projects concurrently with minimal supervision.
• Develop contingency plans and balance priorities across programs.
• Communicate project status to Operations leadership and stakeholders.
• Set program plans and budgets; track actuals, forecasts, and schedules.

Kenntnisse

Project management

Cross-functional leadership

Process development

Quality systems

Regulatory knowledge

Scheduling & planning

Communication (verbal and written)

Ausbildung

Bachelor’s Degree in Engineering or science or related discipline

Jobbeschreibung

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Purpose:

The Program Manager, MES will organize and lead high-performing cross-functional teams in the planning and execution of programs associated with assembly, labeling and packaging of drug delivery devices and combination products. This individual provides leadership and coordinated project management for all manufacturing and/or technical activities needed to ensure successful tech transfer and commercialization of the assigned products by integrating the efforts of R&D, S&T, Quality, Supply Chain, Regulatory. After product launch, this individual is responsible for managing the capacity strategy for the product, assurance of supply programs and cost reduction initiatives across the network.

Responsibilities

• Assemble and lead matrixed cross-functional teams comprised of scientist and engineers responsible for all operational aspects of process development, manufacturing, quality assurance and quality control spanning multiple sites
• Implement site transfers, new indications, new presentations and lifecycle projects for on market programs on time and within budget
• Proactively identify and drive technical and project plan related issues to closure by working with all relevant functional lines and effectively troubleshooting and driving decisions
• Manage multiple projects concurrently, operating with minimal supervision
• Understand project drivers, requirements, scenarios and options. Proactively drive development of contingency and/or risk mitigation plans.
• Manage competing timelines and make difficult decisions regarding priorities among projects.
• Effectively communicate and present project status to Operations senior management and stakeholders
• Accountable for setting program and project plans, including timelines and expenses, that meet business and organizational objectives and ensuring those plans are achieved.
• Define budget requirements and report monthly actuals, LBE, and Plan/LRP schedules per financial schedule

#LI-AL1

Qualifications

• Bachelor’s Degree in Engineering, science, or closely related discipline, or equivalent technical experience plus demonstrated competence
• 10+ years of combined experience in positions related to process development, project management, engineering/process support and manufacturing
• Must have strong knowledge of GMP Manufacturing, Supply Chain, Validation, Engineering, CMC technical development and pharmaceutical regulations
• Must have demonstrated organizational and planning skills, excellent verbal and written communication skills
• Must have demonstrated strong project management skills with successful delivery of projects
• Must be able to effectively facilitate the resolution of complex scientific, technical, analytical and business issues across functional lines
• Plant experience a must
• PMP certification a plus
• Proficiency in multiple languages a plus

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the timeof thisposting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission,incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless anduntil paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html