Scientist Upstream Process Development

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General information

 

Scientist Upstream Process Development

At HALIX, we are an international team with leading experts from around the world dedicated to the realization of our clients' projects.

 

To support us in these client projects, HALIX is looking for a Scientist USP. In this role, you will oversee (the USP part) of up to 3 projects of various complexity, take tactical and operational decisions and you work with your team and clients, to make these projects a success.

Your tasks

Firstly, you interact with our clients on a regular basis to translate requests into work packages, experiments or actions, coordinating the work internally and update on progress of the USP development. Secondly, you ensure development of reliable and robust USP process at the target scale for GMP Manufacturing, And thirdly, you provide information on CMA's, CPP's, specs and input for tech transfer to GMP Manufacturing, for process validation runs and trouble shooting in GMP. Typical oversees 1 - 2 projects AMD part, with low-medium complexity. Additionally you provide scientific input to business development or prospect requests during acquisition.

 

Furthermore you:

  • Translate request for proposal to internal resource requirements and timelines
  • Organize and provide technical updates to clients and internal stakeholders on project status (USP work)
  • Discuss risks with internal stakeholders (multi-disciplinary) and clients and conclude on mitigations
  • Take operational and tactical decisions (for USP part)
  • Monitor timelines of the work package and quality of experiments in the USP project team
  • Train USP Associates or new USP Scientists on the job
  • Set-up / discuss process development experiments, or tests (QbD if required) with small team of Associates
  • Execute (complex) process development experiments
  • Write or review process development protocols, draft-SOP's, Batch Records and reports
  • Select with Analytical Method Development which assays to do on which sample points (if needed)
  • Oversee data and information quality and logging (eg. ALCOA+)
  • Assist in / execute systematic trouble shooting upon issues with the process
  • Coordinate and co-execute transfer and installation of client process in development lab
  • Give input to process transfer to GMP manufacturing and define/give project specific training to operators
  • Provide input and coordinate Process Validation runs with Manufacturing (eg CPP's)
  • Write or review Process validation protocols and reports
  • Initiate and execute general process improvements to improve safety/lead time/efficiency (across departments)
  • Contribute to internal knowledge sharing initiatives
You have
  • PhD, minimum of 3 years industry experience / MSc. minimum of 10 years industry experience (mostly development)
  • Experience in Biosciences, Biochemistry,  Bioprocess Engineering, Biotechnology, or related
  • USP development experience in a bio pharmaceutical production environment, adherent and suspension cell lines, lab scale to 1000L bioreactor preferable single use, production of recombinant proteins (viral)vaccines and antibodies
  • Skilled in external client contact, R&D, project coordination, working in BSL2 facility, tech transfer to manufacturing, cGMP and FDA guidelines, QbD and DoE
Who are we looking for?

We are looking for a Scientist who wants to work in a young and dynamic company full of opportunities. You are flexible, self-starting and you have a strong entrepreneurial spirit.

Our offer
  • You will be part of a steadily growing and dynamic biopharmaceutical company offering a great environment for self-starters.
  • A culture that is characterized by entrepreneurial spirit and close and transparent communication. The patient’s well-being is always our top priority. This combination is the basis for an interesting and challenging environment.
  • You will be working in our dynamic headquarters in Leiden.
  • Being part of a company that is focused on excellence in GMP Manufacturing.
  • A competitive salary that matches your responsibilities and experience.
 
Your application
We look forward to hearing from you! We are interested in your CV, but we also want to find out more about your ambitions, your personality and what drives you to apply. So be sure to include a brief cover letter telling us why you are a match for this position. The application process consists of an introduction by the Recruiter, two interviews either via video call or live at our office in Leiden with the Hiring Manager and/or a Department Specialist followed by contract negotiations. Depending on the vacancy, an assessment could be part of the process.
Important notice to search firms and recruitment agencies
HALIX does not accept unsolicited approaches from recruitment agencies and/or search firms (such as, for instance, the sending of resumes) for any job posted on this or a referring website. All recruitment agencies and search firms are required to contact HALIX Recruitment via recruitment@hal-allergy.com to enquire about a potential recruitment or search agreement with HALIX.
HALIX, Bioscience as a Service
HALIX is a fast growing, biopharmaceutical contract development and manufacturing organization (CDMO) focused on viral vector and recombinant protein products. We support our customers with the development & commercialization of biologics enabling the treatment & prevention of life threatening conditions such as cancer, COVID-19, influenza and other infectious diseases. Our state of the art GMP manufacturing facilities and our experienced and dedicated team of people ensures manufacturing capabilities which meet the highest quality standards, a service oriented way of working and a flexible mindset. If you too would like to become part of an innovative and challenging contract development and manufacturing organization (CDMO), then this is a perfect opportunity!
HALIX is headquartered in Leiden, where all disciplines work under one roof, from development to sales. We work in an informal, culturally diverse organization with room for growth and continued personal development. HALIX is located in the middle of the thriving and energetic Leiden Bio Science Park, the largest innovation district of the Netherlands in the field of Life Sciences & Health. The central train station and the ancient city center of Leiden are just a 5 minute bike ride away from our office.