2021-1284 - Director CMC Development
You have overall responsibility for directing the (CMC) development activities with regard to manufacturing processes and methods for analysis of allergen preparations for therapeutic and diagnostic use and with regard to contract development activities being executed upon assignment of third parties.
As Director CMC Development you provide overall product, process and analysis vision for HAL Allergy and guidance to ensure affordable, high quality deliverables. The Director CMC Development establishes that all stages of product development are conducted as projects with cross-functional deliverables and timelines. You will manage a group of 20 highly skilled department heads, technicians and scientists.
- Lead in resolving technical issues (i.e., trouble shooting) related with the commercial manufacturing of HAL Allergy’s products and in relation to contract services for third parties. Manage the central role of the departments responsible for chemistry, manufacturing, and control (CMC) management, to ensure the integration of regulatory, quality, and operations aspects within the development process.
- Provide leadership in optimizing resource and capability usage for the development activities to achieve the company goals
- Ensure high visibility of the development activities within the company and represent these also externally (e.g. at regulatory authorities).
- Provides leadership in establishing and executing the CMC development strategy for the HAL Allergy product portfolio.
- Coordinates departmental budget and cost monitoring.
- Proposes CMC development strategies for HAL Allergy and customer projects in close collaboration with other stakeholders.
- Manages CMC project/program activities, scheduling and distributing tasks, monitoring, evaluating provides regular progress reports (verbal and written) and ensure documentation of study plans, results and reports
- Monitors, implements and reviews processes and procedures for the CMC project teams, initiating and driving innovation and improvements where appropriate.
- Manages CMC activities for HAL Allergy with regard to process, analytical and formulation development and tech transfer to Operations and QC.
- Ensures high-quality of the work performed by the CMC project teams and make sure that new and improved manufacturing processes comply with relevant regulatory guidelines (e.g., GMP).
- Recruits/attracts qualified, knowledgeable colleagues and coaches them to reach their performance goals.
- PhD in natural sciences, bio-processing or food technology (or equivalent) with a minimum of 10 years of relevant experience in pharmaceutical (CMC) product development
- Solid experience in project management and management of a line- and matrix organization in the field of (bio-)pharmaceutical product development in an industrial setting is a requirement
- Good knowledge of regulatory requirements with respect to CMC activities in pharmaceutical development projects.
- Good knowledge of GMP and relevant pharmaceutical regulatory guidelines and quality directives.
- Good knowledge of and experience with validation and transfer of manufacturing and analytical processes.
- Experience interacting with regulatory authorities.
- Experience with dossier writing and regulatory scientific advice meetings.
- Good command of the Dutch and English language, both verbally as in writing.
You as a person are flexible and able to manage people with different backgrounds, and expertise into a well-functioning department.
- Strong managerial and project management skills in combination with being pro-active, pragmatic and enabling employees to be successful;
- Experience in problem solving and critical thinking;
- Ability to inspire and motivate people, with a strong focus on collaboration, transparency, and team effectiveness.
- We offer you a highly dynamic job in an interesting environment.
- You will be working from our headquarters in Leiden, where the products are produced on site.
- HAL Allergy offers great benefits including a competitive salary, 13th month, 30 holidays, contribution to pension and health insurance.
HAL Allergy is a modern leader in the field of biopharmaceuticals, located in the Leiden Bio Science Park in The Netherlands. Our core business is the development and manufacturing of therapies and diagnostics for allergic diseases.
With offices in major European countries, HAL Allergy is one of the European top players in the allergy immunotherapy business. Established in 1959 HAL Allergy has a long experience in developing, producing and selling allergy therapies with an immuno-modulatory effect, resulting in a reduction of symptoms and long-term disease suppression. These therapies are primarily used against common allergies such as hay fever, house dust mites allergy and allergic reactions towards wasp or bee stings.
We employ around 300 highly specialized people across various functions. The departments at our headquarters include Research & Development, Production, Quality Assurance, Clinical Development and Regulatory Affairs. Our staff works closely together with leading research institutes. At our locations in Germany, Poland, Austria, Spain and Italy we mainly focus on service and sales activities.
We are a steadily growing and dynamic company with a culture that is characterized by entrepreneurial spirit and a friendly and helpful atmosphere. The patient’s well-being is always our top priority. This combination is the basis for an interesting and challenging environment.
In addition to the core business of HAL Allergy, our subsidiary HALIX was founded in 2012. HALIX is a contract development and manufacturing organization (CDMO) licensed for the contract manufacturing of clinical and commercial medicines according to GMP standards. As an end‑to‑end service provider, HALIX will serve its customers the full range from the first development steps to start of commercial production after successful registration of products.