Vacancies

Senior Consultant CMC / Biotechnological Medicinal Products

Kinesis Pharma B.V. provides drug development solutions to sponsors through consulting and contract research services. A premium is placed on the provision of high quality services by combining expert knowledge and experience with cutting edge technology, packaged with efficiency. Steady, self-perpetuating organic growth of the business over the past decade, based on an impeccable reputation in the industry, sees Kinesis Pharma B.V. positioned as a medium sized enterprise with sustainable, ambitious aspirations.

The departments within Kinesis are modelled on the classical disciplines of drug development including CMC, non-clinical, clinical, and regulatory and project management. Within the CMC department there is currently a core team of dedicated experts on biological medicinal development. Over the last three years this team has supported quality development of recombinant protein products, gene therapy products, vaccines, cell based products and biosimilar products. The Consultant (CMC, Biological Medicinal Products) will operate within this core team, be associated with the CMC department and report directly to the head of the department, Director CMC.

The Consultant (CMC, Biological Medicinal Products) provides guidance and expertise in the field of CMC for pharmaceutical research and development of biological medicinal products to sponsor’s. The consultant manages CMC-related activities associated with the sponsor’s product development (e.g. process development, analytical development and/or formulation development), including outsourcing and monitoring of CMC activities at contract research or manufacturing organizations. The consultant assists in the preparation, review and management of regulatory documents like the investigation medicinal product dossier (IMPD) or investigational new drug application (IND) to support the clinical trial application (CTA).

The successful candidate will have a university degree in life or pharmaceutical science combined with at least 5 years of relevant experience in industry and/or at regulatory authorities and/or contract research organizations in the field of biological medicinal products. We are looking for a candidate with a science driven mind-set combined with the ability to provide solutions from detailed understanding and interpretation. Specific expertise in the development of production processes for biologics and/or vaccine development is a definite advantage. Valued personal attributes include the ability to operate independently in an organised fashion with irreproachable professional conduct. Excellent multilingual communication skills are highly valued (English language proficiency is essential).

An offer of employment will include a permanent contract with excellent primary and secondary terms of employment, the option of part-time employment and flexible working practices. In our organization you can acquire a high level of responsibility and independence, benefit from the unparalleled breadth of exposure and frequent interaction with our group of experts which will broaden your knowledge, experience and expertise.

For more information you may send an e-mail to Peggy.IJzelman@kinesis-pharma.com. Your letter of application and CV may also be sent by regular mail to: P. IJzelman, Kinesis Pharma BV, Lage Mosten 29, 4822 NK Breda, The Netherlands.