FNBB Services Corp
External Manufacturing Operations Lead
FNBB Services Corp, Atlanta, Georgia, United States, 30383
Make your mark for patients
We are looking for a collaborative, dynamic and results driven External Manufacturing Operations Lead to join is in our External Manufacturing Operations team, based in any of our HUB locations: Atlanta, GA, Raleigh, NC, Boston, MA. This hybrid role (at least 40% of the time in office) requires up to 20% travel both domestically and internationally.
About the RoleIn this position you willlead the operational management of UCB's global Contract Manufacturers (CMO). You will act as the key point of contact for these CMO's for all issues related to the management of operations. In addition, you will support the development and implementation of the UCB external manufacturing strategy.
Who you'll work with
In this position you will work with other UCB stakeholders like External manufacturing business leads, Quality Assurance, Regulatory, Legal, Compliance, Procurement, and Supply Chain.
What you'll doLeading CMO's vendor teams to perform day to day operational management of CMO's in your portfolio. Organize periodic meetings between CMO's and UCB extended vendor team and facilitate exchange in a constructive way.Delivering technical expertise to support UCB's CMO in order to ensure effective processes, optimize capacity utilization and respect of quality standard.Leading associated improvment project when relevant.Performing 1st line troubleshooting (deviation) at CMO's in scope and lead investigations and CAPA in case of complex , business technical and supply issues.Supporting the implementation of CMO change control in a Coordination or project leader role into the UCB Vendor TeamPerforming product quality reviews and CMO performance review together with QA, Supply Chain, Procurement. Support contract compliance check initiative when relevant.Monitoring capacities and implementing long range capacity plans in coordination with Supply ChainDelivering Technical Expertise for Continuous Improvement of CoG's during the life cycle of all products in scopeLeading multifunctional teams to ensure tech transfers, validation, investigation and business support activities to/from CMO's for existing and new products.Supporting regulatory submissions related to these projects.Driving CMO risk analysis and implementing identified mitigation plansDeveloping and evaluating business cases and preparing recommendations for make or buy of respective productsMaintaining and sharing technology knowledge and CMO market intelligence. Maintaining the technical knowledge of manufacturing processes currently used at CMOs in scope.
Interested? For this position you'll need the followingeducation, experienceandskills:Master's degree with minimum 5 years of significant Operation management experience in GMP environment (DP manufacturing)International Exposure in pharmaceutical project managementStrong technical knowledge on DP manufacturing all forms and Finished Goods packaging.Experience in External Manufacturing functions combined with knowledge in injectables or medical devices manufacturing is an advantage.Fluent in English (written &spoken). Knowledge of other languages (French) is an advantageAbility to lead multi-functional teams, influence others, hold teams accountable, results orientated, able to manage complex projects from development through commercialization and to attain results.Must be able to manage external business partners and relationships to influence partners to deliver results that UCB needs.Relationship management - internal / externalCommunication and networking external and internalNon hierarchical management skills (persuasion)Project ManagementBasic financial & business knowledgeAvailable to travel outside the US 2-3 times per for a period of one week minimum
This positions reasonably anticipated base salary range is $159,480 - $ 186,060 per year. The actual salary offered will take into account internal equity and may also vary depending on the candidate's geographic region, job-related knowledge, skills, and experience, among other factors.
Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!
About usUCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.
Why work with us?At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.
As an Equal Opportunity Employer, we are open to all talent, and adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US-Reasonable_Accommodation@ucb.com for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
Job Req: 88260#J-18808-Ljbffr
We are looking for a collaborative, dynamic and results driven External Manufacturing Operations Lead to join is in our External Manufacturing Operations team, based in any of our HUB locations: Atlanta, GA, Raleigh, NC, Boston, MA. This hybrid role (at least 40% of the time in office) requires up to 20% travel both domestically and internationally.
About the RoleIn this position you willlead the operational management of UCB's global Contract Manufacturers (CMO). You will act as the key point of contact for these CMO's for all issues related to the management of operations. In addition, you will support the development and implementation of the UCB external manufacturing strategy.
Who you'll work with
In this position you will work with other UCB stakeholders like External manufacturing business leads, Quality Assurance, Regulatory, Legal, Compliance, Procurement, and Supply Chain.
What you'll doLeading CMO's vendor teams to perform day to day operational management of CMO's in your portfolio. Organize periodic meetings between CMO's and UCB extended vendor team and facilitate exchange in a constructive way.Delivering technical expertise to support UCB's CMO in order to ensure effective processes, optimize capacity utilization and respect of quality standard.Leading associated improvment project when relevant.Performing 1st line troubleshooting (deviation) at CMO's in scope and lead investigations and CAPA in case of complex , business technical and supply issues.Supporting the implementation of CMO change control in a Coordination or project leader role into the UCB Vendor TeamPerforming product quality reviews and CMO performance review together with QA, Supply Chain, Procurement. Support contract compliance check initiative when relevant.Monitoring capacities and implementing long range capacity plans in coordination with Supply ChainDelivering Technical Expertise for Continuous Improvement of CoG's during the life cycle of all products in scopeLeading multifunctional teams to ensure tech transfers, validation, investigation and business support activities to/from CMO's for existing and new products.Supporting regulatory submissions related to these projects.Driving CMO risk analysis and implementing identified mitigation plansDeveloping and evaluating business cases and preparing recommendations for make or buy of respective productsMaintaining and sharing technology knowledge and CMO market intelligence. Maintaining the technical knowledge of manufacturing processes currently used at CMOs in scope.
Interested? For this position you'll need the followingeducation, experienceandskills:Master's degree with minimum 5 years of significant Operation management experience in GMP environment (DP manufacturing)International Exposure in pharmaceutical project managementStrong technical knowledge on DP manufacturing all forms and Finished Goods packaging.Experience in External Manufacturing functions combined with knowledge in injectables or medical devices manufacturing is an advantage.Fluent in English (written &spoken). Knowledge of other languages (French) is an advantageAbility to lead multi-functional teams, influence others, hold teams accountable, results orientated, able to manage complex projects from development through commercialization and to attain results.Must be able to manage external business partners and relationships to influence partners to deliver results that UCB needs.Relationship management - internal / externalCommunication and networking external and internalNon hierarchical management skills (persuasion)Project ManagementBasic financial & business knowledgeAvailable to travel outside the US 2-3 times per for a period of one week minimum
This positions reasonably anticipated base salary range is $159,480 - $ 186,060 per year. The actual salary offered will take into account internal equity and may also vary depending on the candidate's geographic region, job-related knowledge, skills, and experience, among other factors.
Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!
About usUCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.
Why work with us?At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.
As an Equal Opportunity Employer, we are open to all talent, and adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US-Reasonable_Accommodation@ucb.com for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
Job Req: 88260#J-18808-Ljbffr