Cmc External Network Lead
Vor 2 Tagen
Anjarium is a privately held, early-stage biotechnology company focused on creating a new class of non-viral gene therapies to deliver more predictable, enduring, and inclusionary ways to tackle genetic disease throughout a patient’s lifetime. The Company’s versatile platform aims to leverage breakthrough science and expertise at the interface of genetic medicine, synthetic biology and nanoparticle engineering to generate a pipeline of advanced gene therapies with unique competitive advantages over current viral-vector based gene therapies. We are backed by leading international and strategic investors Abingworth, Gimv, Omega Funds, Pfizer Ventures and Surveyor Capital (a Citadel company).
Currently headquartered at Biotechnopark in Zurich, Switzerland, we are rapidly expanding our teamand are looking for talented and creative individuals, driven by patient outcomes, to join us. Our team is passionate about building a new generation of durable genetic medicines for life-threatening diseases while pushing forward the frontiers of gene therapy.
**About the Role**:
The successful
**CMC External Network Lead** will oversee the Anjarium supply activities outsourced to CROs and CDMOs by implementing mechanisms and tools enabling successful implementation of internal manufacturing process and controls’ execution to deliver on multiple projects.
**Key Responsibilities**:
- Support the identification of negotiations and coordination with external partners
- Set up the RFPs in line with the internal stakeholders (e.g., QA, legal, project management, CMC, Finance functions) to ensure the timely contracts establishment to execute on projects’ needs
- Be responsible for the establishment and monitoring of the governance process, escalation and update to the management
- Support Tech Transfer Leads as appropriate to ensure an excellent relationship with external and internal partners
- Support Tech Ops in defining and executing the “Build vs. Buy” strategy, in line with the global vision, specifically to:
- Oversee the non-viral vector, plasmids and critical raw materials manufacturing technologies
- Lead the identification and selection of CROs and CDMOs
- In collaboration with QA, establish common models and practices to drive efficient transfer of processes to GMP plants
- Effectively align with the partners and the overall program priorities
- Drive execution of global initiatives, technology and activities in order to strengthen technical development excellence at Anjarium through external and internal innovation, quality and productivity
- Ensure that all solutions and products are delivered in compliance with all pertinent corporate and legal guidelines on HSE and quality requirements
- Ensure alignment with all required regulation and guidelines in Operations and Projects in order to guarantee permanent regulatory readiness
- Influence/persuade others and work according to appropriate policies, HSE, and Anjarium values.
**Qualifications and Experience**:
- Bachelor's degree in pharmacy, biopharmaceutical technology, biochemistry or equivalent scientific degree, desirable MSc./Ph.D. or equivalent experience
- Experience in the management of technological projects in production, knowledge Technology Transfers and GMP production, experience in the production of biological active substances or other comparable production
- Ability to manage projects and external parties
- Strong written and verbal communicator in English
**Key Interpersonal Skills**:
- Excellent communication and negotiation skills
- Comfortable to work within a fast-paced environment
- Open minded and easily approachable person, strong collaboration and team working skills
- High personal standards with requirements in return for their working environment such as transparency, respect and caring communication
- Submission of unsolicited resumes in advance of an agreement between Anjarium and any external staffing agency or recruiter does not create any implied obligation on the part of Anjarium Biosciences AG. _
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