Chemistry, Manufacturing and Control Scientist

06/07/21

Location

Heidestraat 19, 9820 Merelbeke, Belgium

Function type

Chemistry, Manufacturing and Control Scientist

Vacancy

Job description

Ziphius Vaccines is a pharmaceutical company that focusses on the development of mRNA-based vaccines. We are looking for an enthusiastic employee for CMC support of our pre/clinical programs. You will be working in a multidisciplinary team, where collaboration and teamwork are encouraged.

You will have responsibility for:

  • The development and execution of sound strategies for manufacturing of our vaccines

  • Vendor Management: Interact with contract manufacturing organizations (CMOs) to complete preclinical, IND-enabling and Phase I activities. Ensure vendors stay on-task and complete contracted work in a timely manner. Integrate deliverables and dependencies between vendors seamlessly.

  • All aspects of drug substance and product, including development and manufacturing: process development, scale-up, transfer, characterization, validation; analytical method development, qualification/validation; formulation, fill-finish; testing and release; review and approval of documents.

  • Project management: coordination of internal functions and external parties to establish contracts, budgets, sourcing of critical materials and supply of product candidates to clinical sites.

  • Format, edit, coordinate, and review regulatory documentation for inclusion in INDs, CTAs, and other worldwide submissions. You will compile documentation for submissions to the EMA and to foreign regulatory agencies and maintain regulatory documentation.

  • Coordinate with other departments to collect information for use in regulatory submissions

  • Proactive identification of problems/risks/issues and facilitate issue resolution and risk mitigation

Preferred qualifications

  • You have a PhD in the life or physical sciences, e.g. biochemistry, microbiology, biotechnology, chemistry, chemical engineering, etc.

  • 5+ years of relevant experience with a proven track record of successful CMC project management

  • Experience with outsourcing of manufacturing work to CMOs/CDMOs

  • Technical knowledge concerning release specifications and analytics

  • QP support for quality agreements and release

  • Experience with cGMP and ICH regulations, working in a government regulated environment (EMA, FDA, FAGG, …)

  • Firm understanding of new product development processes and procedures to ensure all new products are designed to include all necessary regulatory requirements

  • Experience in the field of mRNA/vaccines will be considered as a strong advantage

  • Strong problem solving and project management skills with a proven ability to manage multiple projects and simplify/organize complex tasks

  • Excellent written and verbal communication skills with a proven track record of influencing and negotiating with others

  • Strong attention to detail and ability to independently prioritize and multitask

What we have to offer

The position is full-time. We offer a market-compliant salary, including an attractive package of fringe benefits. We offer you a challenging career in a dynamic and fast-growing company, including opportunities for strong personal development within a multidisciplinary environment.

Why Ziphius Vaccines?

Ziphius Vaccines' team consists of a well-balanced, diverse group of people with complementary skills. The team members are united by their common passion for health care and entrepreneurship. Ziphius has a culture of creativity and innovation, supported by its values that include Transparency, Respect, Courage and Integrity.

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A CV as well as a motivation letter can be forwarded by email to HR@ziphius.org.

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