Sr Scientist Upstream Process Development (USP)

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General information

 

Sr Scientist Upstream Process Development (USP)

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 Sr Scientist USP. The Upstream process (USP) development is a sub-department under Development department to cover the key area of activities on USP transfer from clients, USP development, implementation for GMP manufacturing, process characterization, and process validation. The USP team consists of Associate Scientists and Scientists. The purpose of the Sr Scientist USP is to be the USP expert for the company and to functionally lead the USP team.

Your tasks

General and Scientific

  • Responsible for upstream process (USP) transfer, development, characterization, and validation.
  • Acts as the go-to-person in the company for complex USP matters.
  • Identifies scientific breakthrough / developments in USP field for capability expansion. Implements up-to-date guidelines USP laboratory and late-stage USP development and validation activities.
  • Accountable for the deliverables of the USP Team to internal or external client projects.
  • Writes and/or reviews protocols, reports, policies, SOPs, and other documents.
  • Designs USP processes for GMP manufacturing, delivers “USP Process Descriptions” and implements USP processes in GMP facility in collaboration with Production Team.
  • Contributes to strategies and policies related to process transfer, development, implementation for GMP manufacturing and validation.
  • Functionally lead the USP team that includes Scientists and Associate Scientists level. Professionals.
  • Mitigates gaps in internal USP resource requirements. Suggests business cases, priorities, CAPEX requirements, and vacancies.

 

Project management and execution support

  • Provides input on project planning to ensure project plans are defined according to client requests, internal capabilities, and resource availability.
  • Acts as the USP lead (representative) to the project team (or assign someone else from the team) and arrange resources for project execution.
  • Oversights the progress and takes accountability of USP deliverables to the project team.
  • Ensures USP updates with the right content to clients and internal stakeholders (project team, Development teams, management team, and other departments).

 

Business Development Support

  • Responsible for maintaining an up-to-date USP service portfolio for offerings to new clients.
  • Supports internal business developers on appraisal of potential new projects. Provides USP scientific and tactical input to new project proposals.
You have
  • Holds a Ph.D. in Bioprocess Technology or Cell Biology or relevant field with 5+ years of work experience on USP process development in biopharmaceuticals industry or M.Sc. with 10+ years of industry experience.
  • Experienced in managing direct reports or scientific teams or projects.
  • Possesses high-level of expertise on USP techniques / unit operations. This includes: Cell line development, Cell banking, Mammalian cell culture (both adherent and suspension), Bioreactor engineering, Scale-up, Scale-down, Media development, Process intensification.
  • Experienced in developing both early- and late-stage USP processes for different types of biopharmaceuticals (e.g. proteins, antibodies, viral vectors).
  • Has deep understanding of quality-by-design (QbD) and ICHQ11 guideline. Has broad knowledge on Biopharmaceuticals development trajectory, CMC development, and GMP guidelines.
  • Trained on pharmaceuticals quality management system (QMS), especially Deviations, CAPA, Change control, Good documentation practice, Data integrity, Quality risk management, and Comparability assessment.
  • Excellent writer of scientific reports and Quality documents.
Who are we looking for?

We are looking for a Sr Scientist who has deep knowledge and practical experience on bioreactor operations and scale-up/down, while flexible to perform general housekeeping, standardization and other non-project related activities. You are self-starting, you have a strong entrepreneurial spirit and you are motivated to join a young and enthusiastic team.

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.