Associate Director, Process Development Lead, Tech Ops

Position

Vollzeit

Director

Ingenieurwesen

Konditionen

EMEA, CH, Kanton Bern, Bern, CSL Behring

Anforderungen

10+ J. Erfahrung

Doktortitel

EU/EFTA-Bewilligung

Beschreibung

Main Responsibilities & Accountabilities

Accountable for the development and execution of short- to mid-term strategies for drug substance process development, including new product introduction and lifecycle management activities
Provide technical and project leadership for process development activities from pre-clinical stage through product launch across the plasma-derived portfolio
Lead process development for major manufacturing changes to unit operations, ensuring robust, scalable, and compliant processes
Drive the assessment, selection, and implementation of innovative technologies to improve process performance, scalability, and product quality
Promote and embed a Quality by Design (QbD) development approach, ensuring alignment with regulatory expectations and internal standards
Act as a change agent to advance new ways of working, including adoption of advanced manufacturing and digital approaches
Lead Process Development execution activities and ensure alignment with project governance and portfolio priorities
Ensure preparation, review, and approval of high-quality technical documentation and regulatory submissions
Collaborate closely with Process Engineering, Manufacturing, and other stakeholders to ensure effective scale-up, technology transfer, and facility fit assessments
Oversee and ensure successful transfer of processes from development to commercial manufacturing
Engage with external partners (CROs, vendors) to optimize capabilities, resources, and project outcomes
Lead and Manages team of employees with respect to resource planning and staff allocation to projects involving the discovery, development and manufacture of new products as well as improvements to existing products
Drive talent development, succession planning, and capability building within the organization
Foster a high-performance culture focused on scientific excellence, collaboration, and accountability
Ensure execution of development activities in alignment with project timelines, quality standards, and regulatory requirements
Drive continuous improvement of processes, tools, and ways of working within the function
Ensure compliance with GMP, internal procedures, and regulatory expectations

Aufgaben

Accountable for the development and execution of short- to mid-term strategies for drug substance process development, including new product introduction and lifecycle management activities
Provide technical and project leadership for process development activities from pre-clinical stage through product launch across the plasma-derived portfolio
Lead process development for major manufacturing changes to unit operations, ensuring robust, scalable, and compliant processes
Drive the assessment, selection, and implementation of innovative technologies to improve process performance, scalability, and product quality
Promote and embed a Quality by Design (QbD) development approach, ensuring alignment with regulatory expectations and internal standards
Act as a change agent to advance new ways of working, including adoption of advanced manufacturing and digital approaches
Lead Process Development execution activities and ensure alignment with project governance and portfolio priorities
Ensure preparation, review, and approval of high-quality technical documentation and regulatory submissions
Collaborate closely with Process Engineering, Manufacturing, and other stakeholders to ensure effective scale-up, technology transfer, and facility fit assessments
Oversee and ensure successful transfer of processes from development to commercial manufacturing
Engage with external partners (CROs, vendors) to optimize capabilities, resources, and project outcomes
Lead and Manages team of employees with respect to resource planning and staff allocation to projects involving the discovery, development and manufacture of new products as well as improvements to existing products
Drive talent development, succession planning, and capability building within the organization
Foster a high-performance culture focused on scientific excellence, collaboration, and accountability
Ensure execution of development activities in alignment with project timelines, quality standards, and regulatory requirements
Drive continuous improvement of processes, tools, and ways of working within the function
Ensure compliance with GMP, internal procedures, and regulatory expectations

Anforderungen

Postgraduate degree (preferably PhD) in Life Sciences, Engineering, or related discipline
Extensive experience in biotechnology, pharmaceutical industry, or relevant academic environment
10+ years of relevant experience in process development, manufacturing, or related fields
Proven experience leading teams and managing complex, cross-functional programs
Strong scientific background in drug substance process development, particularly for biologics or plasma-derived products
Demonstrated ability to lead and develop high-performing teams in a global, matrixed environment
Experience across early- to late-stage development, including scale-up, tech transfer, and regulatory submissions
Strong analytical, problem-solving, and decision-making skills
Excellent communication, stakeholder management, and influencing skills
Experience working in multicultural, international environments

Vorteile

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are
By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future

Unternehmen

CSL Behring

Biotechnology

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.