Technical Lead

3 weken geleden

Leiden South Holland Netherlands, NL Batavia Biosciences Voltijd

About Batavia Biosciences

The short version is that Batavia helps to optimize the route from drug discovery to clinic.

The reality is that we do much more than that: by leveraging the combination of our expert workforce, our broad, international academic and public network and our extensive range of high-end services, we design the optimal route for our customers to reach the one person that we all are 100% committed to: the patient.

To help us take biopharmaceutical development to the next level, we look forward to welcome you as our new Technical Lead.


About the job

We are looking for a Technical Lead within our Project Management Office. The Technical Lead has a key role in setting up customized proposals that meet customer requirements. The Technical Lead is responsible for evaluation of scope, costs and duration for commercial projects, including technical and commercial fit. The technical lead works in close collaboration with Business Development, Batavia’s SME’s as well as Project Managers/ Directors and is Batavia’s technical/scientific representative in customer interactions. The Technical Lead is able to promote strategic objectives and can translate Customer needs in well designed and profitable strategical solutions within Batavia’s technical capabilities.

Proposals can range from production of a research batch of biopharmaceutical product up to a complete trajectory of viral seed stock generation, production process and analytical development, and manufacturing of clinical batches under cGMP. Also technology development projects in collaboration with non-for-profit organizations such as the Bill and Melinda Gates Foundation are in scope.


To be successful as a Technical Lead it is important that you are knowledgeable, an excellent communicator, pragmatic and punctual in a hands-on approach. You should be skilled at building consensus among diverse stakeholders. In this challenging and rewarding position you are in the heart of our business, dealing with all layers of the organization.



Requirements

You are a Biotech Professional with a PhD in pharmaceutical sciences or bio-engineering, vaccinology, gene-therapy or equivalent by experience. You have at least 15 years’ experience in the Biotechnology industry with experience in the different phases of product lifecycle development.


  • Quick understanding of customer’s situation and needs with ability to respond flexible and pro-actively to customer’s wishes.
  • A strong personality, a high degree of flexibility, assertiveness and outstanding communication skills with the ability to interact effectively with clients, Business Development and Batavia’s SME’s.
  • Ability to write quality proposal outlining a well-written and clear strategy.
  • Has proven +15 years of experience in CMC development (Drug Substance, Drug Product, USP, DSP development and Analytics, Quality Operations) or in CMC project management for drug development projects/programs, in particular regarding viral-vaccine development and/or development of viral vectors for gene therapy.
  • Good understanding of cGMP guidelines, FDA regulations, EMEA regulations and other relevant regulatory requirements.
  • You have a good knowledge of information systems and business processes related to project planning, budgeting, and reporting.

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