Program Manager, MES

AbbVie; Barceloneta (PR); On-site; USD 110,000 - 209,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Long-term incentive programs

Job summary

AbbVie Inc. is seeking a Program Manager, MES to organize and lead cross-functional teams in planning and executing programs for device and combination product manufacturing, tech transfer, and commercialization.

You will integrate R&D, S&T, Quality, Supply Chain and Regulatory to ensure successful launches and supply chain readiness across sites. The role requires 10+ years in process development and project management, with strong GMP knowledge, budgeting, and communication skills.

Qualifications

• Bachelor’s Degree in Engineering, science, or closely related discipline.
• 10+ years of experience in positions related to process development, project management, engineering/process support and manufacturing.
• Strong knowledge of GMP Manufacturing, Supply Chain, Validation, Engineering, CMC technical development and pharmaceutical regulations.
• Demonstrated organizational and planning skills, excellent verbal and written communication skills.

Responsibilities

• Assemble and lead matrixed cross-functional teams comprised of scientists 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

Skills

Project management

Cross-functional leadership

Verbal and written communication

GMP Manufacturing knowledge

Regulatory knowledge

Education

Bachelor's Degree in Engineering or science

Job description

• Compensation: USD 109,500 - USD 208,500 - yearly

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

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
• Proficiency in multiple languages a plus

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

The compensation range described below is the range of possible base pay compensation that the Companybelieves 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.

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