Head of Drug Product Development

仕事内容

Make your mark for patientsWe are looking for a Head of Drug Product Development to join us in our Biologics Characterization & Pharmaceutical Development Sciences department, based in Braine-l’Alleud, BelgiumAbout The RoleThis new role is looking for someone who is accountable, agile and decision maker this, in order to act as an Subject Matter Expert (SME) in Drug Product Development and guide/support his/her team in dealing with strategies and external partners.Who You’ll Work With

• John O’Hara as your Manager.
• Your 12 team members (from Scientist to Principal Scientist level) based in Belgium, France and the UK.
• A lot of both internal and external partners at transversal level.

What You’ll Do

• Define and implement the overall strategy for the manufacture of biological drug products through the various stages of development.
• Develop and structure the Drug Product (DP) Development team to ensure appropriate set-up of DP processes for Biologicals. This includes skills, roles, resource, internal equipment and CMO usage.
• Actively seek synergies across modalities and seek collaborations to maximize use of any UCB capacities.
• Liaise with key stakeholders including Downstream Processing Formulation Development, DP Clinical Manufacturing, Devices and Primary Packaging to ensure Drug Product prerequisites are understood and ultimately the DP can be delivered to patients.
• Translate Formulation, Primary & Secondary Packaging, Devices, Technical Operations constraints into robust, green and attractive DP Sterile commercial processes while providing adapted efforts to develop fit for purpose processes at each development phase.
• Develop DP processes for different types of formulation (liquid in vials, PFS or other container, solid (either lyophilized or spray dried)), and any other more innovative formulations addressing parenteral route of administration or others in relation to CQA’s, CPP’s and Risk assessments upon each phase of development.
• Support Drug Product Process Development work at internal and external sites.
• Plan and execute lab-scale and at-scale process development and characterization studies.
• Understanding of drug product manufacturing process operations such as mixing, sterile filtration, and aseptic fill/finish.
• Executing risk assessments and preparing process control strategies.
• Proactively identify, lead and resolve drug product manufacturing problems/barriers.
• Support of clinical complaints and clinical support studies upon request from DP clinical manufacturing.
• Support the DP clinical manufacturing team and CMO management, in defining the DP manufacturing strategy.
• Ensure 1st line troubleshooting and process improvements for projects up to the completion of the validation exercise.
• Ensure 2nd line troubleshooting and process improvements for projects after completion of the validation exercise.
• Support generation of quality documentation to ensure inspection readiness for audit/inspection by regulatory agencies.
• Hire, manage and retain DP Development team members to build and maintain a strong team of experts. Adapt the team structure and competences, as required, according to the stakeholder requirements and their organization.
• Implement a green mindset and design/define DP processes also with a focus on sustainability and overall lifecycle impact.

Interested? For this role we’re looking for the followingeducation, experienceandskills

• At least 10 years of experience in Drug Product Development and Manufacturing or related role within the biopharmaceutical industry is required.

Please note that we are looking for someone that will endorse this role at Associate Director level.

• Expertise in supporting the required drug product activities for the manufacture of cGMP material and timely delivery of activities to internal and external partners.
• U nderstanding of the issues and challenges of developing products from candidate selection to clinical manufacture and commercial registration .
• Good knowledge and technical experience in biologicals parenteral liquid and lyophilized product development and cGMP manufacturing under sterile conditions would be required.
• Fill & F inish experience with viral vectors for gene therapy is not essential but would be welcome.

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 for 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.Learn more about sustainability at UCB and how it is integrated into our business approach.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/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.