Contract Manufacturing Organization (CMO) Manager CMC, Project Manager - Astellas Pharma
Northbrook, IL 60062
About the Job
Job DescriptionCMO Manager CMC PMDo you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.
If you want to be part of this exciting work, you belong at Astellas!Astellas Pharma Inc.
is a pharmaceutical company conducting business in more than 70 countries around the world.
We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families.
Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world.
For more information on Astellas, please visit our website at .This position is based in Northbrook, Illinois.
Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Candidates interested in remote work are encouraged to apply.Purpose and Scope:The CMO manager is responsible for coordination and management of contract manufacturing organization (CMOs) at a regional and global scale during development and commercialization of Astellas products.
The CMO manager is assigned to manage the performance of the overall CMO portfolio or individual CMO, depending on the needs.Able to manage regional CMOs with a typical spend of <$100 million.
Support the higher CMM function levels in managing their project where needed and requested.
Give input in CMO strategy discussions within CMM.The CMO Manager is responsible for cross functionally align with internal stakeholders such as QA, PPM, CMC labs and SC towards CMOs to support Astellas strategy.The main goal is to create and maintain strong relationships in support to stable supply in compliance by working as One Astellas.Essential Job Responsibilities:Management and coordination of CMOs for commercial manufacturing and drug development in a cross-functional setting at a regional and global level.Assure stable supply for the patients by building relationships with CMOs to improve their performance.
Clear and transparent CMO life cycle management by cross functional discussions at regional and global level.Execution of Business Review meetings with CMO on a regular basis and facilitation of other meetings as needed.Track and record CMO performance including operation and quality KPI’s and discuss a plan for improvement where needed.Participate in (global) project teams to ambassador the aspects of the CMO business relation.Give input upon request and take ownership of certain procurement tasks.Point of contact when escalation for issue resolution at the CMO is required.Location(s)IL, NorthbrookRequirementsQualifications:RequiredEducation: BS or MS degree in Pharmaceutical, life sciences or other relevant field. Strong verbal and written communication skillsAbility to interpret and communication reporting results Experience:~ 5 years relevant experience out of a pharmaceutical environmentExperience working in cross functional team environment.Experience in working within a matrix organization.Communication, negotiation/influencing, and social skills with a good sense of diplomacy both in a scientific and industrial environment, both relating to peers and higher management.Good understanding of drug development process, bio processes, GMP and ICH.Preferred:Knowledge of commercial supply chain.Able to lead cross functional teams within Astellas.Experience working in a global GMP environmentWorking Environment:At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home.
We believe this will optimize the most productive work environment for all employees to succeed and deliver.
Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.This position is based in US and may require approximately 20% travel, to CMO sites from time to time, based on the needs.Salary Range: $131,000 - $175,000 (NOTE: Final salary could be more or less, based on experience)Benefits:Medical, Dental and Vision InsuranceGenerous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks401(k) match and annual company contributionCompany paid life insuranceAnnual Corporate Bonus and Quarterly Sales Incentive for eligible positionsLong Term Incentive Plan for eligible positionsReferral bonus program#LI-TR1
If you want to be part of this exciting work, you belong at Astellas!Astellas Pharma Inc.
is a pharmaceutical company conducting business in more than 70 countries around the world.
We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families.
Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world.
For more information on Astellas, please visit our website at .This position is based in Northbrook, Illinois.
Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Candidates interested in remote work are encouraged to apply.Purpose and Scope:The CMO manager is responsible for coordination and management of contract manufacturing organization (CMOs) at a regional and global scale during development and commercialization of Astellas products.
The CMO manager is assigned to manage the performance of the overall CMO portfolio or individual CMO, depending on the needs.Able to manage regional CMOs with a typical spend of <$100 million.
Support the higher CMM function levels in managing their project where needed and requested.
Give input in CMO strategy discussions within CMM.The CMO Manager is responsible for cross functionally align with internal stakeholders such as QA, PPM, CMC labs and SC towards CMOs to support Astellas strategy.The main goal is to create and maintain strong relationships in support to stable supply in compliance by working as One Astellas.Essential Job Responsibilities:Management and coordination of CMOs for commercial manufacturing and drug development in a cross-functional setting at a regional and global level.Assure stable supply for the patients by building relationships with CMOs to improve their performance.
Clear and transparent CMO life cycle management by cross functional discussions at regional and global level.Execution of Business Review meetings with CMO on a regular basis and facilitation of other meetings as needed.Track and record CMO performance including operation and quality KPI’s and discuss a plan for improvement where needed.Participate in (global) project teams to ambassador the aspects of the CMO business relation.Give input upon request and take ownership of certain procurement tasks.Point of contact when escalation for issue resolution at the CMO is required.Location(s)IL, NorthbrookRequirementsQualifications:RequiredEducation: BS or MS degree in Pharmaceutical, life sciences or other relevant field. Strong verbal and written communication skillsAbility to interpret and communication reporting results Experience:~ 5 years relevant experience out of a pharmaceutical environmentExperience working in cross functional team environment.Experience in working within a matrix organization.Communication, negotiation/influencing, and social skills with a good sense of diplomacy both in a scientific and industrial environment, both relating to peers and higher management.Good understanding of drug development process, bio processes, GMP and ICH.Preferred:Knowledge of commercial supply chain.Able to lead cross functional teams within Astellas.Experience working in a global GMP environmentWorking Environment:At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home.
We believe this will optimize the most productive work environment for all employees to succeed and deliver.
Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.This position is based in US and may require approximately 20% travel, to CMO sites from time to time, based on the needs.Salary Range: $131,000 - $175,000 (NOTE: Final salary could be more or less, based on experience)Benefits:Medical, Dental and Vision InsuranceGenerous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks401(k) match and annual company contributionCompany paid life insuranceAnnual Corporate Bonus and Quarterly Sales Incentive for eligible positionsLong Term Incentive Plan for eligible positionsReferral bonus program#LI-TR1
Source : Astellas Pharma