Specialist Change Planning

Description

Position at Seagen

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines.

As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells.

Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission.

By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world.

Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary :

The principal objective of the Change Planning Program Specialist (PPIM) is to ensure continuous supply by planning for post-approval changes throughout theSeagen supply chain.

The individual in this role will be responsible for the day-to-day operations of the Change Planning business process across all programs.

An important element of the job is to develop and ensure changes are managed through the business process and developed for successful implementation prior to entering into the Quality Management System.

This individual will have leadership and administrative responsibilities for change planning and includes training of change owners and functional support.

Responsible for reporting change status to CMC and Partners, as necessary. Must have a broad understanding of how functional areas interact to support product supply, including regulatory and change management areas.

Experience in a regulated industry is preferred. This position will closely work with all internal and external resources to minimize the impact of changes to supply and production plans.

This position is a key interface between manufacturing operations, Quality, CMC teams, Regulatory, and Supply Planning. This position must be able to build and maintain strong partnerships with all internal and external stakeholders and lead discussion, problem solving efforts and support process improvements to ensure supply goals are met or exceeded.

Principal Responsibilities :

Responsible for daily management and coordination of change requests through Change Planning business process to support continuous improvement and regulatory commitments for Seagen’s supply chain

Maintains reports of changes and lead discussions to plan for changes

Communicates change plans across functions and assists appropriate teams to ensure successful implementation

Lead cross-functional team to manage change planning process to ensure minimal impact of changes

Oversee and report high level timelines for implementation of changes

Work closely with Regulatory to ensure appropriate supply is approved for market

Qualifications :

Minimum 5+ years of experience in change management, project management, planning, scheduling, and / or supply planning in biotech / pharmaceutical industry

Experience in anFDA regulated atmosphere

Experience in working within matrix organizations and works effectively with cross-functional and multi-location / multi-cultural teams

Exhibits creativity in adapting to changing situations

Excellent verbal and technical written communication skills, excellent interpersonal skills, and negotiation skills are essential

Attention to detail and organizational skills are critical to success of organization

Experience working with an integrated enterprise level planning system. (QMS, SAP, Oracle

Works only under general direction

Independently determines and develops approach to solutions

Minimal travel (

Education :

BS / BA Degree in a business or life science field preferred

The hiring pay range for this position is $95,000 to $123,000 per year based on skills, education and experience relevant to the role.

Other components of total compensation include a competitive equity grant at the time of hire and an annual bonus.