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(Associate) Director of Analytical Development/Quality Control
Headquartered in Nijmegen, The Netherlands, Tagworks Pharmaceuticals is a dynamic biotech company with strong backing from prominent US and European investors. Specializing in proprietary in vivo click chemistry, Tagworks is committed to improving the effectiveness and reducing the toxicity of systemic cancer treatments. With operations in The Netherlands and as well as in the USA, Tagworks pioneers unique approaches towards antibody-drug conjugates, prodrugs, and targeted radiotherapeutics through its "Click-to-Release'' platform, rooted in Nobel Prize-winning research. To further strengthen the organization, we are looking for a (Associate) Director of Analytical Development/Quality Control.
The position
Our (Associate) Director of Analytical Development/Quality Control is experienced in defining, leading and managing the analytical strategy for Drug Substance and Drug Products, encompassing both small molecules and biologics. You possess a strong background in clinical stage products and demonstrate a pragmatic, fit-for-purpose approach to analytical development. The role involves being a key member of the Chemistry, Manufacturing and Controls (CMC) team, this role will drive the analytical project strategy, including the development of contingency plans and risk evaluations throughout clinical development. You oversee all AD/QC aspects of product development, with responsibilities including specification setting, method development and validation, stability and release testing as well as characterization testing. You provide support to pre-clinical and early-phase clinical development as well as analytical transfer of assays to contract testing labs. You collaborate internally and externally to manage all analytical issues effectively. Additionally, you are responsible for authoring and reviewing analytical documents to support regulatory submissions and responding to agency requests on analytical topics.
The requirements
We expect our (Associate) Director AD/QC to bring
- A BSc or MSc degree in a relevant scientific discipline or equivalent experience;
- A minimum of 5-10 years of experience in analytical development or QC roles within the pharmaceutical or biotechnology industry, covering both small and large molecules;
- Experience in working with external parties, such as CDMOs and contract labs;
- An in-depth understanding of regulatory expectations in analytical development;
- A “roll up your sleeves” mentality and the ability to execute tasks as needed in a small company environment;
- Experience with ADC’s;
- Proficiency in English, oral and written.
You are a team player who can collaborate and work successfully with multiple key stakeholders. You have strong verbal and written communication skills. You are a highly motivated, resourceful individual who can set goals, shift priorities, work independently and collaborate effectively with project teams. Finally, you have good organizational skills and attention to detail.
The offer
You will join a group of passionate and very skilled professionals working towards a common goal. We offer a set of attractive and competitive benefits, recognizing and rewarding our talented and motivated employees.
Our culture and values
At Tagworks, our culture is built on innovation, collaboration, inclusivity and achieving results. We prioritize teamwork, flexibility, resilience, adaptability, and fulfilling commitments.
How to apply
Please send your CV together with a cover letter to hr@tagworkspharma.com.
Curious about what we do? Get in touch!
Contact
T +31 85 800 8550
info@tagworkspharma.com
Address
Tagworks Pharmaceuticals BV
Toernooiveld 1
6525 ED Nijmegen
The Netherlands
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