Shire CMC Program Manager in Lexington, Massachusetts
The Product Lifecycle Management (PLCM) PDTS Program 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 process (preclinical to commercial). The PLCM PDTS program manager will ensure the programs stay on track and are within the expected budget and timelines. The PLCM CMC program manager works closely with the CMC lead to guide the team in developing program plans which bring programs successfully through the lifecycle process and is in alignment with product strategy, management and Health Authorities’ requirements. Great communicator, able to identify risks and escalate issues, as required.
Leads the Tech Ops Product Team & PDTS Subteam on a dual leadership basis, along with the CMC lead.
Coordinates and schedules team meetings.
Establishes information sharing and communication structure (e.g. SharePoint).
Drives execution of programs by translation of product strategy into team goals and milestones in alignment with stage gate process.
Owns program documentation including: agenda, minutes, action items, dashboards, goals and milestones, risk register, mitigation plan, decision log, FTE tracker, timeline, etc.
Resolving project constraints and prioritization of tasks together with CMC lead.
Facilitates the use of project management tools to achieve a balanced, data driven and risk-based decision making process.
Definition of mitigation and/or contingency plans. Executes scenario planning and risk assessments. Develops options for the teams.
Ensures project progress and upcoming deliverables are understood by the team by using PM tools.
Creates and updates project plan. Holds team members accountable for on-time completion of tasks or milestones assigned to support program plan.
Reports program status into governance meeting with CMC lead, as appropriate.
Responsible for program budget, PDTS resource allocation/tracking and overseeing capital expenditure, as appropriate.
Acts as resource for development/implementation of project management tools and methodologies.
Coordinates lessons learned sessions.
Actively models behavior to support the development and maintenance of a high-performing team via effective meeting management, business communication, and timely follow-up and escalation.
Aim for best in class PM approach by constant exchange with colleagues.
Team Management - 50% of time
•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
•Use decision making tools to help the team make complex development decision
• Oversee CMC activities and ensure alignment with global strategy
Project Management - 50% of time
• Establish team goals/milestones 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 develop appropriate mitigation plans with CMC Lead and Team
•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
• Ensure regular updates to senior management as well as timely issue escalation, if required
KEY SKILLS, ABILITIES & COMPETENCIES
Proficient prioritizing and driving complex programs to milestone completion.
Skilled facilitator of global cross-functional teams in a matrix environment.
Knowledge of biotechnology/pharmaceutical product development process including manufacturing process, comparability/feasibility studies, stability studies, analytical development and clinical/commercial operations.
Demonstrated competency and hands-on experience of typical CMC activities.
Strong communication skills to effectively inform key updates & issues across all levels of the organization.
Readily grasps main points in communications and is capable to convey program status in a clear and concise manner.
Strong English writing and oral presentation skills.
Experience at working both independently and in a team-oriented, collaborative high pressure environment is essential.
Strong leadership skills (persuasive, encouraging and motivating).
Willingness to constantly improve PM tools, meeting structure, planning approaches, etc.
Ability to work within rapidly changing environment and to quickly adapt to new situations.
EDUCATION & EXPERIENCE REQUIREMENTS
Minimum 5 years project management experience in Chemistry, Manufacturing & Controls (CMC) environment, with 8+ 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.
OTHER JOB REQUIREMENTS
Some travel may be required.
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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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.
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.