Director of Drug Product Development
A global healthcare company is advertising a vacancy for a Director of Drug Product Development position. The organisation specialises in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. The company's products and services have been used to help care for critically and chronically ill patients. This is an exciting opportunity to bring expertise and skills to an established and in-demand company.
- Strategically define and oversee drug product process development activities for biosimilars products.
- Key member of the Biosimilars CMC team responsible for the drug product technical aspects of Biosimilars development e.g., drug product process development, characterisation, and validation of the drug product process and submission of CMC documents.
- Provide technical and scientific oversight of commercial drug product processes to ensure consistency of DP.
- Oversee and guide all the drug product development activities around the technical development of a Biosimilar; including, drug product process development and generation of drug product, technology transfer, process characterisation, validation and submission of CMC documents.
- Define technical development that follows the principles of Quality by Design (QbD) and specify activities, milestones and costs (with other members of the CMC team).
- Drive issue resolution in order to achieve Biosimilarity within the pre-defined analytical similarity corridor with respect to drug product attributes.
- Provide scientific and technical operational guidance for the drug product process development activities to the Biosimilars Development Teams, Drug Product Development & Manufacturing Sites.
- Contribute to the selection of the primary packaging containers.
- Provide technical and scientific oversight of licensed drug product processes to ensure consistency of supply.
- Serve as the technical drug product expert for regulatory consultations/interactions; including briefing book and dossier creation and question response.
- Build and sustain transparency with key internal customers in to ensure engagement within the Biosimilars teams.
- Develop and maintain scientific expertise in Biosimilars development including up-to-date knowledge of relevant CMC regulatory guidelines and requirements.
Skills and Requirements
- Minimum 8 years in pharmaceutical/biotech company specialising in drug product activities; preferably with at least part in a manufacturing setting.
- Previous experience working with biosimilars would be an advantage.
- Education: Pharmacy, biotechnology, biophysics, biochemistry or similar pharmacy, biotechnology, biophysics, biochemistry or similar.
- Strong knowledge of biologics with a focus on drug development activities.
- Ability to operate in a global matrix organisation with various functions.
- Skills in managing and influencing constructive interactions with pertinent functions and external stakeholders across multiple cultures in a dynamic matrix environment.
- Fine interpersonal, networking and teamwork skills.
- Excellent organisational and time management skills.
- Entrepreneurial mindset; drives results and proactive work style.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, collaboration, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, manages complexity, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
- Fluency in English; German and/or French would be beneficial.
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 contact Patrick Franke at +44 0207 440 0632 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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