Manager, Formulation and DP Lead
ProClinical is working with a Swiss Biotech Company that is seeking a Formulation and DP Development Lead to be based in Lausanne on a permanent basis.
The Formulation and Drug Product Development Lead is responsible for the design, formulation and all phases of product development from concept to scale-up of the company NBE and NCE. The range of activities goes from pre-formulation, formulation development and characterization, production of scale-down batches and scale-up for clinical supply. Typical spectrum of formulation ranges from solid oral dosage forms to parenteral liquid injectable. In this position, he/she interfaces with Analytical labs (internal and/or external) for testing of excipient compatibility, raw material qualification, and drug product stability. He or she will direct studies to define optimal pre-formulation, formulation development and DP development approaches in collaboration with identified CMOs.
In addition, he/she evaluates/interprets data and communicates results to management and the CMC team as required. He/she contributes to the introduction of scientifically/quality driven approaches such as QbD or DoE (Design of Experiments).
- Ensure transition of Research manufacturing processes into Development
- Establish solid scientific approach in the development of DP manufacturing processes
- Define formulation and DP development strategies in collaboration with the CMO and develop suitable and scalable DP manufacturing process(es)
- Identify and manage allocated budget and resources requirements
- Responsible for production of small-scale / pilot-scale batches
Skills and Requirements:
- Doctorate (PhD) in Chemistry, Chemical Engineering, or Pharmacy and relevant industry experience
- Has at least 10 years of experience working across a broad range of oral solid and non-sterile liquid manufacturing technologies. Experience with high protein concentration formulation is a plus
- Has experience with GMP requirements
- Must be forward-thinking and be able to lead and contribute to scientific/technical discussions
- Has strong communication skills including verbal, written, and scientific data presentation
- Has strategic thinking and work collaboratively within and outside of the group
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Alannah Chauhan on +44 203 861 8210 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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