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Let's push the boundaries together and make the most of your talents!

Drug Substance Development Lead

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Production
Job ID:  68691

Drug Substance Development Lead

 

Help us transform patients' lives.

 

At UCB, we put our heart, soul and skills into making a difference for people living with severe diseases.  Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in this pioneering adventure? 

To strengthen our Pharma Sciences department, based in Braine l’Alleud, Belgium, we are looking to fill the position of: Drug Substance Development Lead

 

As a UCB Drug Substance Development Lead you like to work in an environment where you can:

  • Be responsible for managing external and internal API (Active Pharmaceutical Ingredients) projects
  • Be responsible for all technical, business, quality, and regulatory aspects of drug substance development and manufacturing

 

As a UCB Drug Substance Development Lead, you will contribute by:

  • Overseeing Drug Substance development and manufacturing operations; lead all stages of DS development efforts to commercialization. Overseeing process optimization, qualification batch manufacturing and process validation. Proactively identify process issues and work collaboratively within the company and the CRO to address challenges.
  • Building and maintaining strong working relationships with CRO/CMO partners ensuring activities are managed collaboratively, efficiently, and effectively. Facilitate technology transfer activities at CRO/CMO.  
  • Playing a critical role in driving strategic decisions around DS manufacturing and planning as well as ensuring that DS supply will meet worldwide regulatory scrutiny. Providing input to that development of program strategy, budgets, timelines, and project development plans, as needed.  Helping form, challenge and drive the Development vision and strategy.
  • Establishing development phase appropriate raw material and chemical intermediates manufacturing and supply chains.
  • Working collaboratively with Analytical Development and Quality Control to ensure Development Phase appropriate raw materials, starting materials, intermediates and release testing methodology is applied.
  • Providing guidance to manufacturing, CMC and QA to ensure compliance with all applicable regulations and assist in resolutions of issues identified.   
  • Working collaboratively with Early Stage Development and Drug Product Development and other internal stakeholders. Establishing API physical characterization such as solubility, salt-form screening, polymorph assessment and particle size analysis. 
  • Identifying, classifying and reporting deviations as appropriate, and typically working to resolve more complex deviations.
  • Being responsible for the mentoring, technical leadership and/or direct supervision of junior scientists and contractors.
  • Participating in due diligence assessments and may serve as the department’s direct interface with alliance partners with responsibility for risk assessment, financial and strategic planning, and project guidance responsibilities to protect the Company’s interests and resource investments

 

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

  • PhD degree in science, chemical engineering, or related field is preferred but B.S./MS. may be considered based on combination of experience and professional accomplishments.
  • At least 5 years of experience working with GMP pharmaceutical development, manufacturing, and testing of API.
  • Experience with peptide, oligonucleotide, and small-molecule development from pre-clinical to IND to NDA.
  • Technical knowledge of analytical method qualification, process validation, and establishing product specifications.
  • Ability/experience in defining and implementing a strategy
  • People management: ability to manage a team  
  • Experience in working in compliance with US, EU, and ICH GMP requirements, experience with writing or reviewing submission documentation, responses to regulatory inquiries and inspections.
  • Experience with regulatory compliance inspections. Proficiency with interpreting and implementing GXPs, FDA, EMA, PMDA, ISO and ICH Regulations and guidelines
  • Demonstrated ability to work independently, handle multiple tasks simultaneously, prioritize, negotiate and meet critical timelines.
  • Excellent oral and written communication in English. French is an asset.
  • Strong interpersonal skills to effectively communicate with teams, peers, management, and external contacts on a global scale.
  • Proven organizational skills and ability to lead cross-functional teams. 
  • Prior experience operating in and managing change control programs in support of a commercial product. 
  • Openness to travel from times to times (±10%)

 

About us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what 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 and 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.

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. 

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