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(Associate) Director Small Molecules 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 antibody-drug conjugate (ADC), prodrug, and targeted radiotherapeutic approaches 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 Molecules CMC.
The position
Our (Associate) Director Small Molecules CMC is responsible for technical aspects of our small molecules including API and drug product. Your work includes process development, optimization and scale-up, 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 on-going and planned non-clinical 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 Molecules 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 execute tasks as needed in a small company environment; we offer hybrid working with a minimum of 2 days per week in the office.
You are a team player who can collaborate successfully with multiple key stakeholders. You have strong verbal and written communication skills. You are a highly motivated, resourceful individual who can set goals, prioritize, work independently and work effectively within 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
We look forward to receiving your CV and cover letter at hr@tagworkspharma.com indicating the vacancy you apply for.
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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