Analytical Project Leader

Conteúdo do emprego

Make your mark for patients

We are looking for an Analytical Project Leaderto join us in our Pharma Sciences organization based in Braine-l’Alleud, Belgium.

About The Role

To strengthen our Analytical Sciences for Pharmaceuticals (ASP) group in charge of the analytical development of our synthetic molecule pipeline, we are looking for an Analytical Project Leader with a strong experience in both Drug Substance and Drug Product analytical development of small molecules. The position is based in our Supply & Technology Solutions (ST&S) hub in Braine l’Alleud, Belgium.

In this position, you will contribute to the advancement of our portfolio of projects entering pre-clinical and clinical phases until commercial registration, launch and throughout the lifecycle of our marketed products.

What You Will Do

As a UCB Analytical Project Leader you like to work in an environment where you can:

• Have overall responsibility for the project management of the analytical activities and associated strategy in the field of Chemistry, Manufacturing and Controls (CMC) Development for defined therapeutic development projects
• Define and drive the analytical development strategy in full alignment with the other CMC and associated functions (R&D, Clinical and Commercial Supply Chains, Nonclinical and Clinical Development, CMC Quality Assurance, Regulatory Affairs, Commercial Manufacturing, Marketing)
• Plan, track, drive all project related analytical activities and expenditures.
• Be empowered to drive the decision-making process in a multidisciplinary matrix organization.
• Ensure fit for purpose and robust analytical deliverables with respect of the project timelines and costs for best patient solutions.

The nature of the position is global and requires a strong understanding of all analytical development disciplines

As a UCB Analytical Project Leader you will contribute by the following activities:

• To define the analytical development strategy and contribute to the high-level milestone plan (CMC Plan) in alignment with the overall UCB development strategy
• To define the timelines, budget and resources and to coordinate all analytical activities to meet the overall project timelines and deliverables
• To act as the analytical single point of contact in the CMC development technical team, representing the different involved analytical departments (Analytical Sciences for Pharmaceuticals department, QCs, Contract Laboratory Organization (CLO) if necessary)
• To foster efficient collaboration with the other analytical functions in order to ensure high-quality fit-for-purpose analytical deliverables.
• To monitor progress against project plan and report progress updates to CMC development technical team
• To establish and track project budget for external activities
• To update the CMC plan with respect to analytical activities on a regular agreed basis in line with updated global development plan and strategies.
• To prioritize the analytical activities effectively (in collaboration with Portfolio Team leaders) according to project timelines and resources constrains.
• To ensure effective communication with all other involved CMC and associated functions as well as with external partners
• To initiate risk assessments and development of risk mitigation strategies regarding analytical activities
• To participate in improvement initiatives as required to ensure best in class project management

Interested? For this position you’ll need the following education, experience and skills:

• Master’s degree in chemistry/sciences
• Strong experience in pharmaceutical industry, including leadership positions
• Solid understanding of the end-to-end CMC development (and associated disciplines) process
• Strong expertise in analytical development for synthetic molecules including method validation requirements, stability studies, forced degradation studies, excipient compatibility studies, impurity (organic, mutagenic, elemental) profile evaluation, specification settings with associated statistical expertise, etc.
• Detailed understanding of regulatory and GMP environments and requirements (ICH guidelines, Pharmacopoeias, etc.)
• Proven project leadership skills, including project planning, monitoring, issue resolution, decision making and reporting
• Organization & planning skills
• Strong experience in budget management and cost control (resources evaluation, outsourcing cost definition, …)
• Proven team leadership, team building and networking skills
• Ability to understand and balanced the priorities
• Customer and result-oriented mindset
• Strong sense of accountability and responsibility
• Critical thinking capability (problem solving)
• Eagerness to continuously broaden and deepen your expertise
• Effective and convincing communication
• English proficiency (oral, written), French is a plus

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 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.

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 on EMEA-Reasonable_Accommodation@ucb.com . Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.