Incyte Corporation
Sr. Manager, Operations, Global IMSC
Incyte Corporation, Wilmington, Delaware, United States, 19803
Overview
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.The Senior Manager, Clinical Supply manages clinical supply chain of compounds in the clinical stage of development.Essential Functions of the Job
(Key responsibilities)*
Manage all aspects of clinical study requirements and Clinical Packaging activities.*
Work with clinical operations, project management and tech ops to establish and meet timelines for clinical supplies available for clinical trials.*
Recommend new procedures and processes to manage the growth of clinical supplies and number of clinical trials being conducted by Incyte.*
Identify external packaging sites, monitors external clinical packaging, and reviews master and executed batch records.*
Coordinate GMP auditing activities at CMOs; provides management with accurate time frames for resolution of delays in obtaining supplies for clinical projects; recommends insight and ideas into procedural improvements as needed and assist in the implementation of the improvements.*
Work with tech ops and clinical operations in managing inventory of clinical supplies before and during clinical studies.*
Develop and manage strategic alliances with contract partners for procurement, packaging, transportation, brokerage, storage and distribution.Qualifications (Minimal acceptable level of education, work experience, and competency)*
BS or higher and minimum 5 years of experience in managing clinical packaging, clinical inventory and distribution.*
Knowledge of US and Global clinical labeling, Ex-US depot and Qualified Person requirements for clinical supplies.*
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.*
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.*
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
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 PrivacyLearn more at: privacy-policyThe 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 Incyte's 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, Incyte's data protection officer, and your supervisory authority (if applicable).Please contact
if you have any questions or concerns or would like to exercise your rights.
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.The Senior Manager, Clinical Supply manages clinical supply chain of compounds in the clinical stage of development.Essential Functions of the Job
(Key responsibilities)*
Manage all aspects of clinical study requirements and Clinical Packaging activities.*
Work with clinical operations, project management and tech ops to establish and meet timelines for clinical supplies available for clinical trials.*
Recommend new procedures and processes to manage the growth of clinical supplies and number of clinical trials being conducted by Incyte.*
Identify external packaging sites, monitors external clinical packaging, and reviews master and executed batch records.*
Coordinate GMP auditing activities at CMOs; provides management with accurate time frames for resolution of delays in obtaining supplies for clinical projects; recommends insight and ideas into procedural improvements as needed and assist in the implementation of the improvements.*
Work with tech ops and clinical operations in managing inventory of clinical supplies before and during clinical studies.*
Develop and manage strategic alliances with contract partners for procurement, packaging, transportation, brokerage, storage and distribution.Qualifications (Minimal acceptable level of education, work experience, and competency)*
BS or higher and minimum 5 years of experience in managing clinical packaging, clinical inventory and distribution.*
Knowledge of US and Global clinical labeling, Ex-US depot and Qualified Person requirements for clinical supplies.*
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.*
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.*
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
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 PrivacyLearn more at: privacy-policyThe 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 Incyte's 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, Incyte's data protection officer, and your supervisory authority (if applicable).Please contact
if you have any questions or concerns or would like to exercise your rights.