Senior Project Manager

Overview

Werfen

Werfen, founded in , is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories.

The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality.

We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA.

Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.

Job Summary

The Senior Project Manager position is a senior position within the Autoimmunity Project Management Office (PMO). This position has strategic responsibility for leading cross-functional teams for effective management of all aspects of assigned projects.

The Srenior Project Manager acts as a liaison between the core project team and stakeholders to drive visibility, accountability, and cross-functional task execution, in alignment with the project plan.

Responsible for driving high performance, solution oriented, and collaborative project teams that foster agility, innovation, trust and communication

From a tactical perspective, Senior Project Manager is responsible for managing multiple large sized projects, usually of medium to high complexity, for either the development of new or improved Autoimmunity diagnostics products, or related to life-cycle management of the existing portfolio of Autoimmunity products.

All work will be performed in accordance with Autoimmunity standard operating procedures and within all Quality Systems, Legal and Human Resource regulations.

Responsibilities

Key Accountabilities

• Leads multiple large sized projects (projects can be part of either one or multiple Programs), usually of high complexity, for the either the development of new or improved Autoimmunity diagnostics products or related to life-cycle management of Autoimmunity existing portfolio of products.
• Leads cross-functional project teams, that might contain representation from multiple departments and disciplines; ensures all project deliverables are delivered with exceptional quality, within scope, time, and At times, project team members may include employees from other Werfen entities or could be external partners, vendors, and / or consultants.
• Accountable for creation and monitoring of necessary project management artifacts, i.e., project plan(s), resource management plan(s), communication plan(s), project budget, and schedules,
• For new development, accountable for establishing and maintaining the Design History File (DHF) for the assigned project(s).

Properly, verifies the Design Control Records, laboratory notebooks, and any associated documentation for all Research and Development activities.

• For Design Changes, accountable for managing all the necessary steps for the successful completion of the change(s) according to established procedures and work instructions.
• Ensures all documentation and testing needs are met, including but not limited to manuals, labeling, training materials or other documents for the successful launch of the new product or successful im plementation of a new process.
• As applicable, accountable for managing the overall relationship with external partners and / or con sultants during the development, testing and transfer phases of Also, accountable for man aging, tracking and reporting against the approved vendor budget.
• Provides guidance, training, mentorship and coaching to junior member of the team and potentially other aspiring project managers within the organization.
• Stays current on project management tools, processes; recommends and implements changes to increase the performance of the Project Management team.
• Evaluates department processes, tools and operations. Makes recommendations for improvements to department management.
• Supports department budget indirectly by managing expenses effectively and provides the neces sary input(s) for estimating and planning of department
• Complies with applicable Autoimmunity standard operating procedures (SOPs), ISO, FDA and other Quality System Regulations (QSR), as well as applicable Environmental Health & Safety, Human Re sources and all other regulatory and administrative policies.
• Reflects the Werfen Values in the quality of work and in establishing and maintaining working rela tionships

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking / Key Relationships

This position works closely with all R&D teams, Marketing, Quality and various other departments and staff throughout Autoimmunity and the rest of the Werfen organization, to achieve strategic, department and operational goals.

Includes collaboration with other Werfen organizations and staff, and third-party vendors.

Qualifications

Minimum Knowledge & Experience required for the position

Education

Bachelor's degree in science in Biology, Microbiology, Cellular Biology, Biochemistry, Computer Sci ence, Software Engineering, Engineering (i.

e., Electrical Engineering, Mechanical Engineering, etc.). or similar field of study required.

Project Management Professional (PMP) certification required.

Experience

• 8+ years running large and complex project management experience required, in research and / or life sciences or pharmaceutical environment highly preferred.
• 8+ years laboratory experience required, in life sciences, autoimmunity or medical devices pre ferred.

Management has the discretion of substituting relevant work experience for a degree and / or making exceptions to the years of experience requirement.

Skills & Capabilities

• Advanced skills in planning and managing complex projects, including agility to adjust in real time to ensure success.
• Advanced understanding of formal project management methodologies.
• Exceptional ability to plan and meet project timelines and project budgets.
• Ability to thrive within a fast paced environment.
• Advanced skills at developing and delivering presentations and training.
• Exceptional communication, negotiation, influencing and emotional intelligence skills.
• Able to influence others in critical situations and resolve conflict.
• Keen attention to detail.
• Advanced knowledge of Microsoft products, including Microsoft Project required.

Travel requirements

Less than 10% of time.

Werfen appreciates and values diversity. We are an Equal Opportunity / Affirmative Action Employer M / F / D / V

We operate directly in over 30 countries, and in more than territories through distributors. Annual revenue is approximately $2 billion and more than 5, employees around the world comprise our Werfen