Director - Head Process Development

vor 4 Stunden

Schlieren, Schweiz Anjarium Biosciences AG Vollzeit

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
** Director - Head Process Development **will lead the Anjarium USP (Upstream Processing) and DSP (Downstream Processing)teams by optimally setting up people, assets, equipment to best serve project needs according to priorities, and to ensure timely delivery of high-quality products and technical solutions. Foster a culture of innovation, empowerment, trust, learning, diversity & inclusion and high performance.

**Key Responsibilities**:

- Leads a Technical Development Team responsible for Upstream and Downstream processing (USP & DSP) of our enzyme-based DNA and Hybridosomes platforms and/or non GMP/GMP Pilot Operations.
- Contributes to definition and implementation of the global department strategy and ensure that both strategic and operational objectives are met or exceeded by setting appropriate priorities for the team.
- Ensures development of adequate DNA and Hybridosomes Drug Substance (DS) manufacturing processes of or ensures their execution, or provides support for development of DS bulk clinical supplies for Development pipeline projects
- Ensures high quality transfer of processes and methods to internal and/or external DS manufacturing sites.
- Ensures the continuous improvement of processes to maintain high quality standards and operational excellence.
- Ensures best practice sharing, knowledge exchange, and cross-functional support within the teams.
- Ensures that all solutions and products are delivered in compliance with all relevant corporate and legal guidelines on HSE and quality requirements.
- Ensures high standards in objective setting, performance monitoring, review, and management, as well as development planning for associates are maintained.
- Ensures that the most talented associates are hired, trained and developed according to the requirements of the organization.
- Achieves a true culture of empowerment and innovation, diversity & inclusion, trust, high performance, and continuous improvement mind-set in the team.
- Ensures that regulatory filings to health authorities are appropriately supported.

**Qualifications and Experience**:

- MSc./Ph.D. in Science.
- Minimum of 10 years of relevant experience; minimum of 5 years in a leadership or people management position with successful performance and track record in the role of line/people manager in Biotechnology, or a related industrial area (e.g., TechOps, Biotech)
- Experience with non GMP and GMP DNA production is a plus.
- Experience in regulatory filings of CTA, IMPD, IND CMC, etc. sections
- Proven track record of successfully managing interfaces to other functions.
- 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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