American Regent, Inc.
Associate Director, CMO Sourcing and Relationship
American Regent, Inc., Charleston, West Virginia, United States,
Nature and Scope
Provide cross-functional leadership in management and governance, where ARI has a pipeline project requiring external contract manufacturing with or without development, including sourcing, qualification, onboarding, relationship management, and offboarding, in collaboration with functional areas and in support of ARI’s strategic objectives. The incumbent will deliver successful alliances that seek to create long-term relationships of mutual value, that either complement or extend our core competencies and expertise. This role serves as the relationship owner for the lifetime of the engagement.
Essential Duties and Responsibilities
In collaboration with R&D, co-develop and review technical RFP/RFI for the purpose of assessing API-CMO or Drug Product-CMO supplier/partner capabilities and preliminary qualification.
Interview supplier on-site at American Regent or at supplier’s location.
Attend conferences supporting new supplier identification or new technologies.
Upon confirmation of technical ability, initiate cross-functional assessment of supplier’s ability to meet quality, compliance, cost, capacity, and delivery requirements within planned/desired technical framework.
Build robust, interactive relationships with cross-functional stakeholders across R&D, RA, QA, Legal, Commercial Operations, Production, Procurement, and PMO.
Once a CMO Partner has been identified, lead negotiation and execution of contracts ensuring favorable, competitive conditions, contract limitations, and risk.
Support R&D in contractual obligations and compliance such as milestone payments, forecasting requirements and fulfillment expectations, and overall performance.
Build strong, trusting relationships with new and existing CMOs to ensure we achieve our mutual goals as part of the alliance.
Track progress, including coordinating the definition and reporting of KPIs, leading periodic health checks to monitor strength and effectiveness of partnership post-approval.
Manage executive-level dashboard on inline CMO statuses, issues, and opportunities.
Identify value drivers and key risks, leading efforts to mitigate risks and accelerate value to both parties.
Lead resolution when conflicts arise, focusing on swift and fair settlement.
Lead change management process including contract amendment negotiation or partnership termination and closeout of any/all activities.
Post-approval, collaborate with Commercial, Technical Services, RA, and Quality on process optimization and adjustments, supporting improvements in costs, quality, timelines, capabilities, and compliance.
Perform any other tasks/duties as assigned by management.
Education Requirements and Qualifications
A minimum of a Bachelor’s Degree, or equivalent in experience, in Pharmaceutical Science, Industrial/Chemical Engineering, business or related life science field, required.
Minimum of 8+ years’ experience in pharmaceutical supply chain sourcing, procurement, technical operations, or external alliance management, ideally with end-to-end supply chain exposure, required.
Proficient in Microsoft suite of products, with moderate to advanced skills in MS Excel and PowerPoint; AS400 preferred.
Excellent written and verbal cross-cultural communication, negotiation, and collaboration skills.
Cross-functional project management skills.
Comprehensive understanding and commitment to standards of business conduct.
Ability to manage multiple projects effectively and efficiently.
A well-developed understanding of injectable manufacturing, development, and ANDA/NDA approval process.
Strong analytical and financial analysis skills.
Must be willing to travel internationally and domestically, up to 50%.
Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules, and operating manuals.
Expected Salary Range:$138,000 - $170,000
The salary range displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills, and experience.
American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k, as well as a wide range of other benefits.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
American Regent Inc. endeavors to make
https://americanregent.com/Careers
accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email
hrtalentacquisition@americanregent.com .
#J-18808-Ljbffr
Provide cross-functional leadership in management and governance, where ARI has a pipeline project requiring external contract manufacturing with or without development, including sourcing, qualification, onboarding, relationship management, and offboarding, in collaboration with functional areas and in support of ARI’s strategic objectives. The incumbent will deliver successful alliances that seek to create long-term relationships of mutual value, that either complement or extend our core competencies and expertise. This role serves as the relationship owner for the lifetime of the engagement.
Essential Duties and Responsibilities
In collaboration with R&D, co-develop and review technical RFP/RFI for the purpose of assessing API-CMO or Drug Product-CMO supplier/partner capabilities and preliminary qualification.
Interview supplier on-site at American Regent or at supplier’s location.
Attend conferences supporting new supplier identification or new technologies.
Upon confirmation of technical ability, initiate cross-functional assessment of supplier’s ability to meet quality, compliance, cost, capacity, and delivery requirements within planned/desired technical framework.
Build robust, interactive relationships with cross-functional stakeholders across R&D, RA, QA, Legal, Commercial Operations, Production, Procurement, and PMO.
Once a CMO Partner has been identified, lead negotiation and execution of contracts ensuring favorable, competitive conditions, contract limitations, and risk.
Support R&D in contractual obligations and compliance such as milestone payments, forecasting requirements and fulfillment expectations, and overall performance.
Build strong, trusting relationships with new and existing CMOs to ensure we achieve our mutual goals as part of the alliance.
Track progress, including coordinating the definition and reporting of KPIs, leading periodic health checks to monitor strength and effectiveness of partnership post-approval.
Manage executive-level dashboard on inline CMO statuses, issues, and opportunities.
Identify value drivers and key risks, leading efforts to mitigate risks and accelerate value to both parties.
Lead resolution when conflicts arise, focusing on swift and fair settlement.
Lead change management process including contract amendment negotiation or partnership termination and closeout of any/all activities.
Post-approval, collaborate with Commercial, Technical Services, RA, and Quality on process optimization and adjustments, supporting improvements in costs, quality, timelines, capabilities, and compliance.
Perform any other tasks/duties as assigned by management.
Education Requirements and Qualifications
A minimum of a Bachelor’s Degree, or equivalent in experience, in Pharmaceutical Science, Industrial/Chemical Engineering, business or related life science field, required.
Minimum of 8+ years’ experience in pharmaceutical supply chain sourcing, procurement, technical operations, or external alliance management, ideally with end-to-end supply chain exposure, required.
Proficient in Microsoft suite of products, with moderate to advanced skills in MS Excel and PowerPoint; AS400 preferred.
Excellent written and verbal cross-cultural communication, negotiation, and collaboration skills.
Cross-functional project management skills.
Comprehensive understanding and commitment to standards of business conduct.
Ability to manage multiple projects effectively and efficiently.
A well-developed understanding of injectable manufacturing, development, and ANDA/NDA approval process.
Strong analytical and financial analysis skills.
Must be willing to travel internationally and domestically, up to 50%.
Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules, and operating manuals.
Expected Salary Range:$138,000 - $170,000
The salary range displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills, and experience.
American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k, as well as a wide range of other benefits.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
American Regent Inc. endeavors to make
https://americanregent.com/Careers
accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email
hrtalentacquisition@americanregent.com .
#J-18808-Ljbffr