Senior Manager, Biologics CMC Project Management

Incyte Corp

DE

JOB DETAILS
SKILLS
Antibodies, Best Practices, Biology, Budget Management, CMOS, Candidate Screening, Communication Skills, Continuous Improvement, Contract Research Organization (CRO), Cross-Functional, Data Processing, Decision Support, Drug Development, Establish Priorities, Information/Data Security (InfoSec), International Operations, Interpersonal Skills, Leadership, Microsoft SharePoint, Multitasking, Onboarding, Organizational Skills, Presentation/Verbal Skills, Problem Solving Skills, Product Development, Product Management, Project Management Professional (PMP), Project Management Software, Project Planning, Project/Program Coordination, Project/Program Management, Regulations, Regulatory Requirements, Regulatory Submissions, Reporting Dashboards, Risk Analysis, Supply Chain, Team Lead/Manager, Team Player, Technical Leadership, Technical Operations, Time Management, Willing to Travel, Writing Skills
LOCATION
DE
POSTED
10 days ago

Overview Job Summary Primary function As a member of the Incyte Technical Operations Tech Ops Global Biologics Development GBD group the Senior Manager Biologics CMC Project Management provides project management leadership and operational coordination for assigned biologics CMC programs workstreams or cross-functional initiatives across development stages. The role partners with the GBD technical lead and cross-functional stakeholders to support translation of program strategy into integrated development plans track priorities identify risks and dependencies and help drive timely aligned execution across Tech Ops Discovery Regulatory Affairs Quality Supply Chain and external partners including CMOs CROs and collaborators. The Senior Manager coordinates cross-functional project team activities supports scenario planning governance preparation and decision-ready project communications and contributes to consistency visibility and execution discipline across assigned programs and project management practices. Essential Functions of the Job Key Responsibilities Coordinate and help drive cross-functional project team activities for assigned biologics CMC programs workstreams or initiatives supporting alignment on priorities deliverables critical path activities and execution across functions. Develop and maintain integrated phase-appropriate project plans that connect CMC regulatory technical and operational activities and identify dependencies constraints and key decision points for review with programproject leadership. Identify track and help escalate risks and issues that could affect scope timelines cost quality or supply and support mitigation planning and follow-up actions. Support resource and budget tracking for assigned programs by maintaining key assumptions inputs trade-offs and program impacts for review with functional and GBD leadership. Support governance preparation by compiling program status scenarios risks options and proposed next steps to enable timely and informed decision-making. Coordinate project management activities with external partners including CMOs CROs and collaborators to support alignment on plans deliverables risks and execution milestones. Maintain dashboards integrated project timelines and team SharePoint sites ensuring project information is current accurate and decision ready. Support execution of mid- to late-stage CMC deliverables including submission-related timelines readiness activities and life cycle management tracking for commercial products as needed. Support onboarding knowledge sharing and best practices with peers and junior colleagues as appropriate and contribute to continuous improvement of biologics CMC project management tools and ways of working. QualificationsProfessional Experience Requirements Relevant experience supporting or managing cross-functional biologics product development projects workstreams or program deliverables is required. Experience coordinating CMC project activities within the pharmaceuticalbiotech industry is required. Understanding of phase-appropriate CMC development and regulatory submission requirements is preferred. Strong project management communication and facilitation skills with the ability to influence without authority are required. Experience supporting resource tracking budget inputs and program reporting is preferred. Experience with monoclonal antibody drug development is advantageous. Minimum of 4-6 years of project management andor product development experience within the pharmaceuticalbiotech industry or equivalent skills and knowledge is required. Degree such as BSMSPhD in Biological Sciences or related discipline or equivalent experience. PMP certification and strong technical background are preferred but not required. Willingness to travel as needed - occasional international travel to partners and CMO facilities with accommodations available for individuals with disabilities. Excellent interpersonal skills with the ability to adapt effectively to changes in organization structures and dynamics. Collaborative self-motivated organized and capable of problem-solving sound judgment and managing multiple priorities. Excellent written verbal and presentation skills. Disclaimer The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties responsibilities and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. Disclaimer The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties responsibilities and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. We Respect Your Privacy Learn more at httpwww.incyte.comprivacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. You may have the right to access delete restrict edit move or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incytes data protection practices here. By accessing this link you can learn about the types of personal data we collect how we use it whether collection and processing is optional sources of the personal data we process how it is shared where it is stored or transferred to how long we keep it and contact information for Incyte Incytes data protection officer and your supervisory authority if applicable. Please contact privacyincyte.com if you have any questions or concerns or would like to exercise your rights.

About the Company

I

Incyte Corp