Sr Bioprocess Technician

About the company

 HALIX, THE HEALTHCARE CDMO

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.

Job description:

In the position of Senior Bioprocess Technician, you will be responsible for the development, implementation and execution of manufacturing processes according to GMP/FDA regulations. Projects at HALIX are related to cell culture, fermentation, down-stream processing and aseptical filling of biological and immunological products.

Your tasks

Development and manufacturing of biopharmaceuticals according to procedures, protocols and batch records.

Accurate and prompt action or escalation on quality related issues.

Development

• Process development based on the technology transfer and/or Process Validation documents.
• Performing experiments needed to develop and optimize process steps/processes or as follow up trouble shooting.
• Performing up scaling studies to production scale.
• Development of analytical and production documentation.
• Participation in multidisciplinary project team as subject matter expert.
• Initiation and implementation of change controls.

Manufacturing

• Preparing and closing out the manufacturing according to GMP/FDA-guidelines.
• Preparing the manufacturing processes: cleaning equipment, requesting and checking the manufacturing documentation, reviewing log books, checking the equipment status and ordering materials required for the process.
• Initiating deviations, performing root-cause investigations. Timely closure.
• Execution of manufacturing processes of cell cultures, infection of the cells, harvesting, clarification including downstream processes.
• Closing out the manufacturing: line clearance, equipment area decontamination, change over. Review of manufacturing batch records.

You have

• HLO/BSc or MSc degree in biotechnology, molecular biology or microbiology.
• Experience in cell culturing, recovery and purification of recombinant protein i.e. monoclonal antibodies, viruses under GMP/FDA regime.
• Who are we looking for?
• Experience in working under GMP/FDA guidelines in a BSL2 facility.
• Working knowledge of GMP/FDA regulations.
• High degree of accuracy, quality oriented.
• Good knowledge of Dutch and basic knowledge of English, verbally and written.
• Pro-active, able to work under time pressure.

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.

Link to vacancy:

https://hal-allergy-halix-cand.talent-soft.com/job/job-sr-bioprocess-technician_1534.aspx