Senior Manager
Stiefel Laboratories, Inc
Rixensart, Belgium
9 dagen geleden

Your Responsibilities :

The Senior Manager - Cell and Viral Drug Substance (CVDS) Belgium will lead a team of experts that predominantly supports Life Cycle activities aimed at Drug Substance process improvements in the commercial vaccine portfolio.

The team will also support Drug Substance process development for candidate vaccines in the pipeline from early to late stage upon need.

The successful candidate will report to the Head of the CVDS department in Belgium, which is part of the Global Drug Substance organization in Technical R&D (TRD).

The scope of the Belgian (CVDS) team is three-fold :

1. Support Life Cycle management and Drug Substance process improvement for commercial vaccine products to ensure sustained supply with consistent quality.

2. Develop cell and viral DS processes with excellent quality, speed to market, and low cost, in line with Quality by Design (QbD) principles and deeper and broader understanding of the inter-

phase & interplay between product and process.

3. Collaborate with other functional groups in TRD organization globally to establish novel technology platforms for future vaccine production with better quality, faster to market, lower cost, and more thorough process and product understanding.

Your Responsibilities :

  • You will develop your team towards excellence and agility in Drug Substance process development, characterization and continuous improvement in line with best scientific & manufacturing practices and QbD principles to enable the overall organization to enhance profitability, increase product and process robustness and improve supply reliability.
  • You will lead the team for scientific and technical support to the Global Industrial Operations (GIO : commercial manufacturing), Procurement and Raw Material QA organizations for Life Cycle activities on commercial vaccine products, with responsibilities including process investigation, optimization, and next-gen development.
  • You will train and coach Manufacturing teams to ensure best practices and best decision taking when processes are modified.
  • You will ensure a strong interface and knowledge sharing with, Manufacturing Science and Technology, manufacturing strategy, site management, Process Science, and engineering departments for building related activities such as revamping, scaling-
  • up or tech transfer to new facilities.

  • Your team will ensure development of scale-able, robust and cost-effective processes up to the final process scale and life cycle support including process evaluation and raw material traceability.
  • You will support upstream AND downstream process development for a wide variety of processes and antigens.
  • You will ensure process development for and production of (pre-)GMP cell banks and virus seeds.
  • You will work diligently with your team and Centre of Excellence (CoEs) across the TRD organization to assess and adopt new cell lines and novel technologies such as integrated High Throughput Process Development, Systems Biology, and Process Analytical Technology (PAT) to achieve better process understanding, robustness and cost-effectiveness.
  • Your team will closely collaborate with the In-Process Analytical organization for the roll-out of the new QbD framework throughout the Belgian DS organization.
  • You will build strong relationships and a collaborative network with the DS organizations in Italy and US aimed at increasing sharing and learning, optimizing capacity and portfolio delivery, better decision making, stimulating people development and pushing top science & technology throughout the network.
  • Basic qualifications :

  • PhD in bio-engineering, biochemistry, biotechnology, chemistry or equivalent or a
  • Master in bio-engineering, biochemistry, biotechnology, chemistry or equivalent.

  • A minimum of 5 years experience in Vaccines Drug Substance Development and / or Manufacturing (Product and Process Expert).
  • Thorough understanding of vaccine upstream and downstream development and / or manufacturing, with working knowledge on global CMC regulatory requirements for vaccine products.
  • In-depth knowledge of legacy, current-gen and next-gen vaccine manufacturing technologies, with experience in several aspects out of the following is required : adherent cell culture in cell factories or on microcarriers / different cell substrates such as MRC-
  • 5, vero, MDCK, HEK293, CHO, insect cells / single-use systems / GMP manufacturing / raw material traceability, animal-free media / scale-

    up and scale-down / technology transfer / suspension cell culture and bioreactor (disposable and stainless steel).

  • Sound scientific methodology, critical thinking and problem solving skills.
  • Interpersonal and influencing skills to engage different stakeholders inside and outside the TRD organization.
  • Ability to work in a multidisciplinary environment.
  • Strong communication skills.
  • Strong People Management skills are a MUST.
  • Ability to lead a team, develop people, set direction, focus on priorities and inspire.
  • Imprinted with a desire for excellence.
  • Optimistic and open-minded.
  • Fluent in English & French are a MUST.
  • Preferred qualifications :

  • Ideally 8 years or more experience in Vaccines Drug Substance development and / or manufacturing (Product & Process Expert or similar).
  • Deep knowledge of Manufacturing processes and strong understanding of Manufacturing constraints.
  • Deep understanding and knowledge of process industrialization method.
  • Deep understanding of the industry trends and a compelling vision of next-generation biopharmaceutical and vaccine development and manufacturing.
  • Thorough understanding of the importance of Systems Biology (-omics), big data, , multivariate analysis predictive analytics and modeling approaches.
  • Why GSK? : Our Department :

    Our Department :

    The TRD Drug Substance organization, develops efficacious, safe and effective vaccine drug substance (antigen bulk) processes from small scale to commercial manufacturing scale.

    The Drug Substance reports into the TRD organization within Vaccines R&D .

    Through our activities & competencies, we generate the following :

  • Information & knowledge that supports & enables to file and register new vaccines (antigen bulk manufacturing).
  • Manufacturing processes & control strategies that are transferred to the clinical and commercial manufacturing organizations.
  • Pilot-scale materials for non-clinical purposes (toxicology studies, stability studies, scale-down models, process reproducibility and robustness evaluation).
  • Critical support to technical Life Cycle projects aimed at remediation, continuous process improvement, reliable supply and capacity increase to maintain existing assets at a competitive edge.
  • Expert understanding of established and emerging bio-manufacturing platforms down to the cellular and molecular level applying QbD approaches to engineer robust and cost-effective processes.
  • Our Company :

    GSK one of the world’s leading research-based pharmaceutical and healthcare companies is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

    At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.

    If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

    GSK Vaccines is one of the world’s leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development.

    We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world’s countries.

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