BRIEF COMPANY PROFILE
Our client is a medium-sized global medtech company headquartered in Greater Copenhagen with several years of history developing, manufacturing and selling its innovative products globally to health care professionals.
Driven by a set of strong values, and with a promising pipeline of new groundbreaking products, our client offers a challenging position in an informal – though dedicated and dynamic – global organization with a high degree of interorganizational collaboration and focus on joint effort and commitment.
The Product Development department is responsible for the development of new products and line extensions – following the product from generation of idea to implementation in production. The department generates data that proves that the design, functionality, efficacy and safety meet specifications and contribute to ensuring that our client's product’s documentation complies with regulatory requirements.
In addition to development, the department’s product experts support our client's existing products with scientific evaluations related to change requests, deviations, customer complaints and regulatory requirements and they support their key partners on requests related to product stability, product efficacy and tender requests.
The role Biosafety Specialist is an integral part of the Product Development department consisting of 15 colleagues (12 Academics, 2 Lab Technicians and 1 Student Assistant) focused on translating user needs and market opportunities into specific concepts and product ideas. In this context, biosafety becomes the focal link ensuring that the biological safety of our client's products is clear and present.
The Biosafety Specialist is responsible for conducting chemical/toxicological risk assessments on new and existing products e.g. driven by change in materials, manufacturing or like. The role will work in close collaboration with a Biosafety colleague and key stakeholders in Product Development, QA, RA, Supply Chain and Production. The position reports directly to the Product Development Manager.
Head of Product Development
Responsibilities & Tasks:
Part of the Product Development team.
Generating and updating Biocompatibility risk assessment
Ensuring implementation of chemical/toxicological risk
assessments and biological evaluations in relation to
material- and production related changes.
Ensuring execution of in vitro and in vivo tests for safety/tox
evaluation in collaboration with contract laboratories.
Understanding, communicating and implementing policies to
ensure ongoing compliance of regulatory requirements.
Continuously staying informed on regulatory demands and
ensuring implementation of such to company-wide
procedures and existing documentation.
Collaborating with key stakeholders across the organization,
hereunder QA, RA, Supply Chain and Production.
Providing scientific support to inquiries from regulatory
Key success criteria:
Ensuring that product safety meets emerging regulatory requirements.
Ensuring seamless and successful cooperation with key stakeholders.
Ensuring that the products are supported by robust and scientifically strong documentation.
Contributing to a collaborative and high-performance culture in the Product Development team and across the wider organization.
M.Sc. degree in Nature Science e.g. Biology, Pharmacy, Chemistry, Biochemistry or like.
Fluent in English (verbally and written) & Fluent in one Scandinavian language (verbally).
Ideal experience and competencies:
+2 years of experience within scientific evaluation of biosafety, e.g. performing toxicological risk assessments etc.
Excellent understanding of GMP and cross organizational collaboration with e.g. RA and QA.
Preferably experience with QSAR, chemical characterization and coordination of in vitro and in vivo test activities at contract laboratories.
Understanding of regulatory demands, including ISO-10993 and preferably in-depth knowledge of relevant standards and regulations in USA, Canada, Asia, Europe and other key markets (FDA, ISO and MDD).
Strong competencies within documentation of scientifically complicated areas.
Preferably supplementary courses/training in toxicological risk assessments.
Is motivated by obtaining company and organization goals and ambitions – and acknowledges that personal goals are best achieved through company success. Inspires others, creates followership and encourages the achievement of set goals by promoting a sense of purpose. Provides inspiration for a positive work attitude and prompts a strong wish to succeed in the team.
Possesses a sense of urgency. Makes sure co-workers/project members have a clear understanding of the direction of the tasks. Takes action while juggling a high number of tasks, organizes resources and direct others toward successful execution of the tasks. Drives projects forward to reach pivotal objectives, and makes things happen and follows through.
Collaborates and works well with others with a view to obtain the team's objectives, while sharing information and supporting others.
Divides problems into relevant parts; sensitively integrates the analytical output into the given context; differentiates between key areas and irrelevant and less important areas; has a logical mind-set; makes sensible decisions on the basis of available information; is able to get an overview of a specific situation and at the same time work detailed with a problem; uses details to gain an overview of a situation.
Possess excellent cross-cultural communication and presentation skills. Is to the point and communicates the central issues in a discussion in a clear, fluent and precise manner. Is able to keep the recipients' attention, is attentive to the needs of others when he/she speaks, and produces written material that is clear, fluent, precise and easy to understand.
Flexible and pragmatic
Is focused on finding the smartest path to solving a problem seeking alternative routes, based on own initiative and pragmatism.
Works systematically, organizes work and effort and is methodical in one's performance. Holds on to commenced tasks and projects and sees things through.