Program Manager, MES

AbbVie; Irvine (CA); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie in Irvine, CA seeks a seasoned Program Manager, MES to lead cross-functional teams across R&D, S&T, Quality, Supply Chain and Regulatory for manufacturing, tech transfer and commercialization of drug delivery devices. You will drive capacity planning and cost-reduction initiatives post-launch.

The role requires 10+ years in process development and project management, strong GMP knowledge, and proven ability to manage multiple projects with executives. PMP is a plus.

Qualifications

• Bachelor’s Degree in Engineering, science, or closely 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 technical development and pharmaceutical regulations.
• Strong organizational and planning skills, excellent verbal and written communication skills.
• Proven project management skills with successful delivery of projects.

Responsibilities

• Assemble and lead matrixed cross-functional teams comprising scientists and engineers for operations across sites.
• Manage site transfers, new indications, new presentations and lifecycle projects on time and within budget.
• Identify and drive issues to closure with functional lines and effective troubleshooting.

Skills

Project management

Cross-functional leadership

Communication skills

GMP knowledge

Plant experience

Education

Bachelor’s Degree in Engineering or closely related discipline

Tools

PMP certification

Quality systems knowledge

Job 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.

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
• Plant experience a must
• PMP certification a plus
• 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 or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable 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