American Regent, Inc.
Associate Director, CMO Sourcing and Relationship
American Regent, Inc., Charleston, West Virginia, United States,
Associate Director, CMO Sourcing and RelationshipNature 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, on-boarding, relationship management and off-boarding, 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, codevelop 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 CMO’s to ensure we achieve our mutual goals as part of the alliance.
Track progress, including coordinating the definition and reporting of KPI’s, 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 close out 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.
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.
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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, on-boarding, relationship management and off-boarding, 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, codevelop 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 CMO’s to ensure we achieve our mutual goals as part of the alliance.
Track progress, including coordinating the definition and reporting of KPI’s, 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 close out 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.
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.
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