Senior Process Manager

ASIT biotech is a Belgian clinical stage biopharmaceutical company focused on the development and future commercialisation of a range of breakthrough immunotherapy products for the treatment of allergies. Thanks to its innovative ASIT+TM technology platform, ASIT biotech is currently the only developer of AIT product candidates consisting of a unique mixture of highly purified natural allergen fragments in an optimal size selection. This innovation results in a short treatment, expected to improve patient compliance and real-life effectiveness. ASIT biotech’s product pipeline entails two novel ASIT+™ product candidates targeting respiratory allergy with the highest prevalence (i.e. grass pollen: gp-ASIT+TM and house dust mite: hdm-ASIT+TM), that could significantly expand the current immunotherapy market. The Company believes that its innovative ASIT+™ platform is flexible and would be applicable across a range of allergies.

ASIT biotech has a headcount of 25 staff members, located at its headquarters in Brussels and laboratory in Liège, Belgium. 

Further information can be found at: www.asitbiotech.com.

Job Description

The ideal candidate has an in-depth knowledge of protein purification and characterisation in context of pharmaceutical manufacturing.

The  job requires at least  10  years of experience  including 5  years in industrial manufacturing operations.

We need a change agent who is passionate, has high energy, and is results-oriented. This role requires experience in pharmaceutical manufacturing (ideally in the context of clinical process development, scaling-up, validation and contract manufacturing activities)

Responsibilities

In this context, the position involves:

•    Organize and coordinateprocess and analytical development activities.

•    Supervise the technology and knowhow transfer, establish the GMP production documentation.

•    Overview, manage and facilitate manufacturing operations conducted at and by independent third party contract manufacturing organizations.

•    Lead, coordinate, facilitate, and motivate all internal and external manufacturing teams to reach alignment on project goals and deliverables.

•   Manage projects within established scope, schedule, and budget.

•    Develop and document high-level strategies for accomplishing specific project objectives.

•    Facilitate and lead effective project meetings, manage change and conflict, and develop resource planning estimates to manage project workload and productivity.

•    Support, inform and align with cross functional project management team members to ensure success of projects, including clinical operations, quality control, quality assurance and regulatory affairs departments.

•    Manage a young, enthusiastic and talented team of researchers

Skills & expertise

•   PhD in Engineering, Chemistry or Biochemistry

•    More than 10 years of industry experience in research, tech transfer and production of proteins (scientific and technical) in an industrial environment (pharmaceutical, biotechnology, and/or medical device industries).

•    Interpersonal and leadership skills to effectively communicate and build relationships with a broad spectrum of audiences at all organizational levels as well as with third party contract manufacturing organizations.

•    Sound technical aptitude and proven ability to grasp general knowledge of multiple disciplines and technologies.

•    Strong competencies in organization and rigor with the ability to lead multiple activities and resources while maintaining a focus on quality.

•   Results oriented.

•   Work ethic, integrity, and professional conduct and appearance.

•   Positive attitude, plenty of energy, and excellent interpersonal skills.

•   Commitment to the company objectives and its success.

•   Able to manage rapid change, associated with pre-clinical and commercial operations in the biotechnology field.

Offer

  • A full time position, permanent contract
  • A remuneration that will be in line with the industry standards + additional benefits.
  • An innovative leading company, which could enable you to explore interesting career opportunities.
  • A multicultural work environment in which competence and quality play an important role