External Manufacturing Operations Lead

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 Role
In this position you will lead 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 do

• Leading 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 Team
• Performing 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 Chain
• Delivering Technical Expertise for Continuous Improvement of CoG's during the life cycle of all products in scope
• Leading 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 plans
• Developing and evaluating business cases and preparing recommendations for make or buy of respective products
• Maintaining 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 following education, experience and skills:

• Master's degree with minimum 5 years of significant Operation management experience in GMP environment (DP manufacturing)
• International Exposure in pharmaceutical project management
• Strong 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 advantage
• Ability 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 / external
• Communication and networking external and internal
• Non hierarchical management skills (persuasion)
• Project Management
• Basic financial & business knowledge
• Available to travel outside the US 2-3 times per for a period of one week minimum

Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities.

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.

Requisition ID: 88260 

Recruiter: Parth Suthar 

Hiring Manager: Sinead Connaughton 

Talent Partner: Sabine Gahot

Job Level: MM I

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