at Incyte Corporation in Wilmington, Delaware, United States
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
As a member of the Incyte Technical Operation's (Tech Ops) Global Biologics Development (GBD) group, the CMC Project Manager liaises with GBD technical leads as well as various functional leads to translate Incyte's biologics program goals and objectives into effective project plans. The incumbent assists in the planning and execution of projects while interfacing with various functions within Incyte (Tech Ops, Discovery Team, Regulatory Affairs, Quality and Supply Chain) as well as all external teams including CMOs, CROs and collaborators/ partners. The incumbent manages the cross-functional Product Development Team (PDT) by creating detailed project plans, including resource planning, tracking project plan execution against established targets, identifying and facilitating resolution of issues, and communicating the project status to different stakeholders (both internal and external) including senior managers.
Essential Functions of the Job (Key Responsibilities)
Create timelines for all activities from candidate nomination to IND submission for all new programs to support Vector Development, Process Development, Analytical Development, Process Transfer (to CMOs/Internal Manufacturing), Manufacturing (Drug Substance, Drug Product Fill/Finish and packaging) and Quality Control.
Manage mid to late stage programs effectively to achieve submission for marketing application(s) in a timely manner; track life cycle management of commercial product as needed.
Work with the technical leads to ensure all CMC team deliverables and activities are aligned with all teams, departments and facilitate communication to ensure clarity.
Lead and facilitate creation of project plans and ensure optimal execution against the plans. Track project progress and ensure project deliverable are met on time.
Proactively communicate project status, changes to approved plan, issues, etc.
Identify and analyze project risks and help guide project teams to develop appropriate mitigation strategies.
Maintain dashboards and team SharePoint.
Provide Project Management support to coordinate and manage CMO activities (Tech Transfer and GMP Manufacturing support), as the primary point of contact.
Organize, lead and facilitate cross-functional team meetings, agendas, project reviews, meeting minutes and action item follow-up by working closely with the team leaders.
Work with the CMC Regulatory Affairs Lead to develop timelines to support CMC submissions.
Qualifications/Professional Experience Requirements
BS/MS/PhD in Biological Sciences or related subjects.
Minimum of 8 years of project management experience within the pharmaceutical/biotech industry.
PMP certification and strong technical background is desirable.
Direct and broad experience in managing cross functional biological product development is required. Experience with monoclonal antibody drug development will be a plus.
Cooperative, independent, capable of critical and strategic thinking and multi-tasking.
Excellent written and verbal communication, and presentation skills.
Excellent interpersonal skills with the ability to adapt effectively to changes in organization, structures and dynamics.
Travel required as needed - occasional international travel to partner(s) and CMO facilities.
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.
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