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Global head adqc gene therapy

Penzberg
Genentech
Inserat online seit: Veröffentlicht vor 16 Std.
Beschreibung

The Position A healthier future. Itu2019s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. Thatu2019s what makes us Genentech! The Opportunity The Global Head of Analytical Development and Quality Control (ADQC) is a key member of the Gene Therapy Technical R&D leadership team. This role is accountable for evolving science-driven, phase-appropriate, and risk-based analytical and quality control strategies for our global enterprise _in vivo_ Gene Therapy portfolio. Your remit spans the entire spectrum from candidate nomination through to commercialization of Gene Therapy related modalities. Your leadership will extend beyond our internal pipeline to actively shape the global Gene Therapy landscape. You will serve as a leading voice in the field, defining the next generation of industry standards and regulatory benchmarks for complex modalities. Core Responsibilities & Strategic Mandate Enterprise Analytical Strategy:Define and evolve the global ADQC roadmap for the entire Roche Gene Therapy portfolio. Ensure a scalable, world-class organization capable of supporting diverse modalities, including AAVs and other Nucleic Acid based formats like plasmids or RNA formats from candidate nomination through commercialization. Organizational Design & Operating Model:Actively shape the global ADQC organizational structure and operating model to meet evolving business needs. You will ensure the function remains agile, appropriately resourced, and seamlessly integrated within the broader enterprise Gene Therapy and Technical R&D ecosystem. End-to-End Portfolio Oversight:Direct the development of science-driven, risk-based analytical strategies. Accountable for the seamless delivery of analytical methods, sample analysis, validation protocols and QC testing for process development and manufacturing across all global sites. Scientific advancement & Innovation: Lead the evolution and global implementation of state-of-the-art analytical capabilities. Champion the development of novel methods for viral vectors and nucleic acids, ensuring the organization remains at the forefront of scientific and regulatory excellence. Global Governance & Partnership:Serve as the authoritative voice for ADQC within integrated project teams and global governance and advisory boards, partnering with Research, Regulatory, QA, MSAT, and Manufacturing to ensure CMC alignment. Actively influence the gene therapy landscape by collaborating with external stakeholders and Health Authorities to define and implement next-generation industry benchmarks. Who You Are Education and background:You hold an advanced degree (Masteru2019s or PhD) in Chemistry, Biochemistry, Biology, or a relevant related discipline and possess a mastery of complex relevant analytical techniques (e.g., HPLC, Mass Spec, Genomics) alongside expert-level knowledge of CMC requirements and GMP standards. Experience:You bring 20 years in research or the biotech industry, with progressively responsible experience in Gene Therapy or Biologics analytical development and at least 10 years in supervisory or lead roles. Domain knowledge:You possess deep technical expertise in viral vectors and nucleic acid formats. You understand the unique analytical and regulatory challenges associated with these platforms for in vivo Gene Therapy applications. You have a proven track record of steering diverse modalitiesu2014AAVs, plasmids, and RNAsu2014 ideally through the entire lifecycle from early-stage development to successful commercial launch. Leadership:You are an inspiring authentic and visionary leader who builds, develops, and empowers high-performing, globally distributed teams. Deeply aligned with VACC (Visionary, Architect, Catalyst, Coach) and Roche Leadership principles, you guide teams through change and ambiguity with purpose, clarity, and a focus on growth in a fast-paced environment. Relocation benefits are available for this job posting. While the primary location for this position is listed as Philadelphia, PA the role may also be based out of Penzberg, Germany. Equal consideration is given to candidates interested in both locations. The expected salary range for this position based on the primary location of Philadelphia, PA is $227,400 - $422,400. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits (https://roche.ehr.com/default.ashx?CLASSNAME=splash) Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (https://docs.google.com/forms/d/e/1FAIpQLSdZWlsbfQOvFVIQgHE\_iDzWUTlhZvj6FytIzjS7xq6IGh1H5g/viewform) .

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