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Tech Transfer Head

ALGER

Catégories: Autre
Secteur d'activité: Industries
Type de poste: CDI
Niveau d'études: Master 1, Licence Bac + 4
Années d'experience: 6 À 10 Ans
Wilaya: ALGER
Publiée le: 29-01-2026 à 08:19:05

Description

This role is responsible for leading, overseeing and optimizing manufacturing processes related to the production of sterile biologic drug products including technology transfer (TT) of products to the site. Designing, implementing the TT program and driving the troubleshooting and improvement of the regular manufacturing processes. Monitor the manufacturing processes to ensure consistent performance and quickly resolve any technical issues. To provide scientific and technical input for regulatory submissions and ensuring compliance with global regulations.Main responsibilities:Participate in identifying continuous improvement projects within unit operations, in partnership with Manufacturing when applicable.Optimize manufacturing processes.Design and implement process improvements to enhance product quality, yield, and efficiency.Perform process risk assessments.Collaborate with cross-functional teams, including manufacturing and quality assurance to support product commercial manufacturing activities.Lead, coordinate and drive the technology transfer activities to ensure smooth transfer of processes from development to manufacturing.Provide technical support, oversight, and training to manufacturing personnel to ensure proper execution of tech transfer batches (PPQs) and commercial manufacturing processes.Contribute to the design and qualification of manufacturing equipment including Single Use systems.Conduct studies and risk assessments to identify potential hazards and mitigation strategies.Support troubleshooting equipment and processes to ensure efficient operation and minimal downtime.Analyze process data to identify trends, optimize performance, and drive continuous improvement initiatives.Technical expertise to ensure compliance with industry standards and regulatory requirements, such as FDA, ISO, and cGMP.Support regulatory submissions and inspections as required.Support manufacturing in the investigation and resolution of production related deviations and compliance issues in a timely manner including identifying effective CAPAs.Leads or assists with deviations, change controls, and corrective and preventive action (CAPA) closures.Makes decisions regarding technical risk assessments for new manufacturing equipment.Main competencies:Tasks and Projects: Demonstrate excellent analytical and problem-solving skills, able to plan, organize and follow up work effectively while focusing on quality towards excellence.People & Relationships: Strong team player with excellent communication skills.Self-Management: Proactively take initiatives and demonstrate a dynamic approach to adapt to changing business needs and environment.Supervisory: Inspiring and motivating team members, setting a positive example, and aligning team goals with organizational objectives. Communication : Clearly conveying information, actively listening, providing constructive feedback, and resolving conflicts effectively. Coaching and Development: Guiding employees by identifying their strengths and weaknesses, supporting their professional growth, and creating opportunities for learning.Education B.Sc. or master’s degree in chemical engineering, Biotechnology, Biochemical Engineering, or a related field required. Experience 10+ years' experience in process engineering, manufacturing science and technology within the pharmaceutical or biotechnology industry, with a focus on sterile biologics manufacturing (preferred) Language Good in written, read and spoken English

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