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Specialist Outsourced Manufacturing

Job description

We are a growing and dynamic organization seeking a Specialist Outsourced Manufacturing, to join our CMC team, responsible to outsource GMP activities and assure the GMP material supply for clinical trials.


The candidate will be responsible to translate the knowledge collected by the research department during the drug lead selection into GMP constraint activities to formulate and manufacture new drugs and supply materials at an acceptable quality for clinical trials. The activities are outsourced and the candidate will manage the outsourced projects making use of scientific and technical leadership. The candidate will also be responsible for writing the regulatory dossiers associated to drug manufacturing and quality.

Reporting to the Head of Product Development and Commercial Supply, the candidate will be responsible to make large and small molecules therapeutics available for the company’s development programs. He will be supported by the CMC team to design and execute the development activities for drug ranging from early preclinical stage to commercial, considering activities as diverse as organic synthesis, formulation optimization, protein manufacturing, analytical method development/validation, drug product manufacturing, stability studies, IMP packaging and logistic, regulatory dossier, GMP compliance. This position provides the opportunity to contribute to a diverse set of contract manufacturing projects in a fast-paced collaborative team environment;

Responsibilities:

  • Supervise drug product formulation and dosage form developments for ocular injections
  • Manage outsourcing of drug substance and/or drug product process development and manufacturing GMP activities, either for organic molecules or biologicals.
  • Liaison with analytical, manufacturing, quality and regulatory counterparts to develop plans 
and protocols for drug product formulations and for life cycle management of established 
products 

  • Write, review and ensure the reliability of technical data related to formulation, process, 
analysis, and stability monitoring for new products to be included in IND, NDA, and ANDA 
 

  • Ensure ongoing adherence to all company policies/procedures, compliance/regulatory 
mandates and quality requirements. 

  • Manage and assist with resolution and closure of change controls and CAPAs 

  • Perform data review 

  • Perform other related duties as assigned to meet departmental and Company objectives.
Skills and personality
  • Bachelor or Master degree in a relevant discipline (e.g. pharmaceutical sciences, Bioengineering or related discipline); 

  • 3-5 years relevant experience in the pharmaceutical, biotech or life sciences industry 

  • Comprehensive understanding of drug substance process, analytical and/or formulation development, drug product manufacturing and GMP requirements.
  • Understanding of chemical and physical properties of active ingredients and excipients as 
they relate to formulation, process and drug delivery 

  • Experience handling of deviations/CAPAs/quality documents 

  • Experience in writing and reviewing of CMC technical documents 

  • Experience with organic synthesis and/or sustained release formulation are an asset 

  • Excellent communication and report writing skills 

  • Experience working in a multi-disciplinary, multi- cultured, international matrix environment; 

  • Fluent written and oral English, any other language is an asset 

  • Knowledge of standard MS-Office programs and databases 

Contract

Executive search

Experience

minimum 3 years

Education

Bachelor and/or Master in Pharmaceutical and Biological techniques

Languages

English

Sector

Pharmaceutical industry

Region

Leuven

Job type

Full-time

 
 

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