JOIN US
(Associate) Director Small Molecule CMC
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. Operating at the Radboud University Medical Center, Tagworks pioneers unique approaches towards antibody-drug conjugates (ADCs), 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 Small Molecule CMC.
The position
Our (Associate) Director Small Molecule CMC is responsible for all technical aspects of our small molecules including API and drug product. Your work includes process development and optimization, solid state and formulation development, technology transfer and ownership of GMP manufacturing at our CDMO’s. Together with a cross-functional team (RA, QA, Analytical Development, Project Management, Clinical, Tox, Biological SME), you ensure the timely delivery of our products to support ongoing and planned non-clinical activities and clinical trials. You coordinate with Clinical Operations, Project Management and external CDMO’s to forecast manufacturing needs and schedule manufacturing runs in accordance with program timelines and budgets. You identify and communicate risks in the manufacturing process including their mitigation. You develop, author and review Standard Operating Procedures, reports, regulatory filings or other controlled documents as needed. You contribute to building and maintaining a phase-appropriate Quality structure to support external CMC operations. You are Tagworks’ overall small molecule manufacturing API and DP expert.
The requirements
We expect our (Associate) Director of Small Molecule CMC to
- Have a BSc or MSc degree in Chemistry or Biochemistry.
- Bring 10+ years of experience in manufacturing and CMC activities within the biotechnology or pharmaceutical industry with significant experience in the field of small molecule drug development.
- Have experience with the design of new syntheses and process improvements to achieve bulk and quality goals, including technology transfer to ensure that the API processes and manufacture of Drug Substance is successful.
- Have experience with formulation development and Drug Product manufacturing. Lyophilization experience is a plus.
- Bring integrated knowledge of all aspects of small molecule API production process and ability to work effectively in cross-functional teams to deliver results within agreed timelines.
- Be proficient in the management of Contract Development Manufacturing Organizations, leading all GMP manufacturing activities.• Bring knowledge of regulatory requirements for small molecule API’s, including authoring and reviewing clinical stage IND and IMPD’s and responding to any regulatory questions.
- Bringing ADC experience is a plus.
- Be accustomed to “roll up their sleeves” and executing tasks as needed in a small company environment.
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
Stay updated
© Tagworks Pharmaceuticals, 2024 | Terms of use | Design by Ape to Zebra