External Manufacturing Ops Lead DP & Device
Atlanta, Georgia, United States
Help us transform patients' lives.
At UCB, we put our heart, soul and skills into making a difference for people living with significant unmet needs. Working together, we blend the best of our talents to deliver thoughtful solutions that patients value. Will you join us in this pioneering adventure?
To strengthen our External Manufacturing unit, based in Atlanta, Georgia we are looking for a talented individual to fill the position of External Manufacturing Operations Lead DP & Device.
You like to work in an environment where you can:
- Be accountable for leading the operational management of UCB's Contract Manufacturers / strategic vendors.
- Lead the UCB Vendor Teams (with members of Supply Chain, Quality Assurance, and global support functions) for the CMO in your portfolio to assure continuous supply of compliant products and related services.
- Manage projects such as technology transfers, new product introductions, process improvements. You will be the key person of contact for the CMO/vendor for all issues related to the management of operations.
- Provide technical support to UCB affiliate team who oversee the operational management of local CMOs.
- Support the development and implementation of the UCB industrial manufacturing strategy related to local and global CMO.
- Support the Head of External Manufacturing DP & Device for the preparation of due diligence.
- Represent the External Manufacturing Team in transversal project / improvement program.
You will contribute by:
- Leading CMO 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 improvement 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, EMPL. 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:
- Bachelor’s Degree
- Minimum of 5 years of operations/project management experience in a pharmaceutical GMP environment
- Strong technical knowledge on DP (Drug Product) manufacturing in all forms
- Experience in External Manufacturing functions combined with knowledge in patches, injectables or medical devices manufacturing
- Ability to manage complex projects from development through commercialization
- Experience leading multi-functional teams, influencing others, and holding teams accountable
- Experience managing external business partners to influence and deliver results
- Excellent communication and relationship building skills
- Basic financial & business knowledge
Why you should apply
At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.
If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.
At UCB, we come together every day to work, laser-focused, on a simple question: How will this create value for people living with severe diseases? By putting patients at the heart of everything we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.
With a team of approximately 7,500 employees worldwide operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases. We are looking for people with passion and empathy who develop a real understanding of patient’s needs and can deliver thoughtful solutions to decisionmakers across the heath care ecosystem.
Curious to know more? Please visit our website www.ucb.com .
UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
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