External Clinical Manufacturing Lead (90287)
External Clinical Manufacturing Lead (90287)
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Job Description
Make your mark for patients
We are looking for anExternalClinical Manufacturing Leadwho isproactive collaborative and results-orientedto join ourManufacturing Operationsteam based at our UCB campus inBraine-lAlleud Belgium.
About the Role
You will define and implement the overall external clinical manufacturing strategy for drug substances and drug products through various stages of development. You will be the primary point of contact for all technical aspects of clinical manufacturing and knowledge/technology transfer with external CMOs.
Who You Will Work With
You will collaborate closely with Technical Solutions Teams External Manufacturing Operations Clinical Supply Teams Quality Assurance and other project stakeholders. You will be supported by Development teams in managing issues deviations and investigations.
What You Will Do
- You will define and implement the overall external clinical manufacturing strategy.
- You will be responsible for the knowledge/technology transfer of manufacturing processes to external CMOs.
- You will manage clinical and stability batch manufacturing ensuring on-time delivery.
- You will author and approve necessary documentation for knowledge transfer and clinical batch manufacturing.
- You will manage deviations and lead investigations and change controls related to transfer activities.
- You will coordinate the shipping of drug substances and products with Supply Leads.
Interested
For this role we are looking for the following education experience and skills:
- Bachelors DegreeorMasters Degreein pharmaceutical sciences or a related field.
- Minimum 5 years of experience in NCE/NBE drug development and/or manufacturing.
- Knowledge of NBE drug substance manufacturing/development and injectable dosage form manufacturing/development.
- Good knowledge of cGMP and regulatory requirements.
- Excellent communication negotiation and teamwork skills.
- Knowledge of analytical preformulation and formulation development is an advantage.
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 us
UCB is a global biopharmaceutical company focusing on neurology and immunology. We are around 8500 people in all four corners of the globe inspired by patients and driven by science.
Why work with us
At UCB we dont just complete tasks we create value. We arent 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 thats 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.
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.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on . Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
Employment Type
Intern
