Scientist II/ Group Leader

24/09/21

Location

TECHNOLOGIELAAN 8, HEVERLEE, Belgium

Function type

Analytical Science

Vacancy

Looking for a new challenge in Analytical Science as Scientist II/Group Leader? KBI in Leuven is growing and is looking for a talented candidate that is willing to make an impact and contribute to the projects developed on our site. 

Join an incredibly talented group of scientists and contribute to bringing new therapies to patients in need.

Who We Are

KBI is a recognized international leader in the contract services field, having earned 2017 CMO Leadership Awards in 6 categories. With five locations in the United States and two in Europe, one in Switzerland and one in Belgium, KBI is expanding its activities in their laboratory in Leuven. 

KBI is operating this state-of-the-art analytical and formulation laboratory with capabilities ranging from HPLC and capillary electrophoresis to process residual analysis and formulation development. 

We intend our initial cadre of scientists in Leuven to develop expertise over a broad technical scope and to form the core of our expanding European capabilities.

The Group Leader or Project Leader positions hold important leadership roles in the AFS Department, responsible for analytical and formulation development aspects of early and late-stage clinical Biologics. Both positions report to the Site Head and Director of AFS, Leuven, and are directly responsible for analytical method development/qualification/validation, drug candidates’ characterization, formulation development and cGMP testing. Both leadership roles require managing direct reports, interacting with clients and close collaboration with other departments to support clients’ process development and manufacturing efforts.

Responsibilities include:

  • Leading or supporting analytical and formulation development programs to ensure proper integration of all project components for meeting sponsor timelines. Developing study protocols and experimental designs emerging protein drug candidates from research into preclinical and clinical studies.

  • Developing, qualifying and tracking performance of analytical methods to deliver an integrated suite of high-quality assays to support preclinical and clinical sample testing and formulation selection. Typical suite of methods include HPLC/UPLC, Capillary Electrophoresis, Imaged Capillary Electrophoresis, ELISA and particle counting/characterization (HIAC/MFI).

  • Characterization of drug candidates with respect to drug substance and drug product identity, purity, structure elucidation and stability by applying analytical and biophysical methodologies.

  • Formulation development for parenteral therapeutics evaluating the critical components by using the one-factor-at-the-time and DOE approach.

  • Performing and coordinating cGMP testing on product release and stability programs. Performing stability trending, provide support for troubleshooting and laboratory investigations.

  • Managing laboratory personnel by providing technical leadership, performing in-depth data analysis and coordinating team efforts.

  • Managing cost and timelines.

Requirements:

  • Degree in biophysical/biochemical sciences, pharmaceutical sciences, biochemical engineering, or other scientific disciplines

  • Experience managing laboratory personnel is required.

  • For Project Leader position, PhD and 2 year experience, MS and 5 year experience, or BS/BA and 10 year experience

  • For Group Leader position, previous experience in industry biopharmaceutical development is required.  PhD and 2 year experience, M.S. and 7 year experience, B.S. and 12 year experience

  • Broad technical competence in protein-based analytics

  • High level, independent problem solving of both technical and logistical project issues

  • Excellent verbal and written communication skills

  • Experience working in a cGMP environment strongly preferred, but not required

Job application