Program Manager, MES

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

Requirements

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

Nice to have

PMP certification; Proficiency in multiple languages

Benefits

Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) to eligible employees; eligibility for long-term incentive programs