The Product Lifecycle Management (PLCM) Project Manager is experienced in the use of project management tools and principles who can manage activities for two or more Technical Operations product teams and respective PDTS sub teams at any stage of the lifecycle stage gate process (preclinical to commercial). The PLCM project manager will ensure the programs stay on track and are within the expected budget and timelines. The PLCM project manager works closely with the CMC lead to guide the team in developing program plans which bring programs successfully through the lifecycle stage gate process and is in alignment with product strategy, management and Health Authorities' requirements. Great communicator, able to identify risks and escalate issues, as required.
50%: Team Management
•Work with CMC lead to set priorities, agendas, plan activities and facilitate decision making
•Facilitate timely & productive team discussions.
•Identify risks and mitigation/contingency plans
•Uses decision making tools to help the team make complex development decision
50%: Project Management
• Establish team goals and objectives with the team and their respective functions. Update progress against set milestones and stage gate process.
• Provide scenario analysis to support timely decision making to ensure execution per plans
• Identify critical issues and discusses with CMC lead to devise appropriate mitigation plan
•Ensure effective coordination of activities and/or deliverables across functions.
•Apply all standardized project tools to manage and document team progress as well as to communicate effectively to stakeholders.
Education & Experience Requirements:
Minimum 3 years project management experience in Chemistry, Manufacturing & Controls (CMC) environment, with 5+ years in the biotechnology/pharmaceutical industry.
Bachelor's degree in the life sciences, business, chemical or industrial engineering or equivalent required. MBA degree and/or PMP certification desirable.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.