You lead cross-functional teams to develop and implement material strategies for cell and gene therapy, ensuring compliance and efficiency in the material qualification and onboarding processes.
Anforderungen
- •Bachelor's degree in Life Sciences, Biotechnology or Engineering
- •Master's degree or PhD preferred
- •8-11 years experience in biopharmaceutical industry
- •6-9 years experience with a Master's
- •3-6 years experience with a PhD
- •Expert knowledge of cGMP regulations
- •Quality assurance principles in Cell and Gene Therapy
- •Deep understanding of materials and regulatory implications
- •Strategic thinking and strong problem-solving skills
- •Commitment to continuous improvement
- •Proficient with IT systems (e.g., SAP, LIMS, EDMS)
- •Experienced facilitator in cross-functional teams
- •Compelling communicator with excellent English
- •Willing to travel internationally (up to 20%)
Deine Aufgaben
- •Lead cross-functional teams for material strategy.
- •Develop and implement material qualification strategies.
- •Plan and coordinate material risk assessments.
- •Manage specifications and material change processes.
- •Establish lean methodologies and standardized processes.
- •Support introduction of new raw materials and technologies.
- •Create and review qualification documents and reports.
Deine Vorteile
Purposeful role in medicine
International and diverse team
Targeted development opportunities
Original Beschreibung
# Materials Scientist (f/m/d) Cell & Gene Therapy
**Penzberg** | **Full time**
### The Position
**About the Position**
Join our Material Science and Strategy team within Pharma Cell & Gene Therapy (PTC) and play a decisive role in shaping the future of Cell and Gene Therapy (CGT). Our team of dedicated scientists and engineers operates in a highly dynamic and cross-functional environment to ensure a reliable supply of high-quality, well-controlled materials for our innovative therapies. As a Material Qualification Coordinator, you will take on a key strategic role, planning and steering the qualification and management of critical materials across the entire product lifecycle.
**Your Impact**
* Leading cross-functional teams from Development, Manufacturing, Quality, Regulatory, and Procurement to successfully execute the material strategy for our CGT portfolio.
* You will develop and implement the strategy for material qualification and onboarding for our cell and gene therapy programs, ensuring seamless alignment across all functions.
* Planning and coordinating key activities such as material risk assessments, the development of specifications, and the management of material changes (Change Management).
* You will establish lean methodologies, dashboards, and standardized processes to efficiently steer GMP material qualification and ensure compliant documentation within our Quality Management System.
* Supporting the introduction of new raw materials and single-use technologies in close collaboration with our manufacturing sites, while also driving the evolution of a holistic material platform strategy.
* Creating and reviewing qualification documents (e.g., USR, risk assessments, technical reports) and providing expert support during audit preparations.
**Your Profile**
* You hold a Bachelor's degree in Life Sciences, Biotechnology or Engineering; a Master's degree or PhD is preferred.
* You bring extensive professional experience in the biopharmaceutical industry and a cGMP environment (8-11 years with a Bachelor's, 6-9 years with a Master's, or 3-6 years with a PhD).
* You have expert knowledge of cGMP regulations and quality assurance principles, ideally within the field of Cell and Gene Therapy (ATMPs).
* You possess a deep understanding of materials, their associated risks, and the regulatory implications within CGT.
* Your approach to work is defined by strategic thinking, strong problem-solving skills, and a commitment to continuous improvement.
* You are proficient with IT systems (e.g., SAP, LIMS, EDMS) and are an experienced facilitator in cross-functional matrix teams.
* You are a compelling communicator with excellent command of written and spoken English and are willing to travel internationally as needed (up to 20%).
**What we offer**
* A role with a true sense of purpose, where you will directly contribute to the development of highly innovative medicines for patients.
* An international and diverse team that fosters a culture of collaboration, trust, and continuous personal and professional growth.
* Targeted, individual development opportunities designed to help you realize your full potential.
*The position is limited to 2 years.*
**Roche is an Equal Opportunity Employer.**