Direct message the job poster from Porton Pharma Solutions Ltd.
Responsibilities Work closely with site leadership to support design, procurement and commissioning of production equipment and automation systems in accordance with process requirements and compliance.
Supports PQ and process validation execution.
Plan and support routine operations and ensure the facility is fully functional to support project work, including preparation of labour and budget forecasts that anticipate facility, equipment, and workforce needs as well as definition of robust process parameters for the manufacturing campaigns.
Coordinate and communicate directly with all support functions for aligned, routine planning, compliance, and maintenance activities.
Work with site leadership and commercial functions to host client visits / audits of the pilot plant.
Direct leadership and interface with clients as required, to optimize productivity, quality of services and advance capabilities.
Work with site leadership to plan and support maintenance and capital investment activities, evaluate manufacturing schedule constrains, risks, and feasibility of performing projects.
Support shutdown planning and execution, and update capacity utilization metrics.
Ensure the pilot plant operates in a GMP environment, carry out tasks and complete documentation in a compliant manner.
Implementation and continuous improvement of manufacturing procedures, policies, and systems in alignment with or exceeding industry standards in the way that detailed understanding of the manufacturing process is recorded and enables further improvements, where required or possible.
Participate in technology transfer and operational readiness activities to implement new production processes and new lines, ensuring scalability and reproducibility.
Utilize your expertise in organic synthesis, process development and scale-up to troubleshoot technical challenges and optimize reaction conditions.
Transfer knowledge of the pilot plant operation through training and other forms of support to R&D staff and deploy such knowledge for the purpose of continuous improvement in working practices and processes.
Ensure compliance with regulatory requirements, including FDA regulations, ICH guidelines, and customer specifications.
Implement quality control measures to monitor product quality, purity, and yield throughout the manufacturing process.
Conduct regular inspections and audits to identify areas for improvement and ensure continuous compliance with quality standards.
Participate and contribute to the selection process of new Pilot Plant team members and take responsibility for the personal development and performance management of all team members.
Drive safety culture in manufacturing and spread it among other functions in the company.
Qualifications Expertise in organic synthesis, process manufacturing, and scale-up.
Familiarity with implementing operational excellence.
Good knowledge and competence in the field of automated processes.
EDUCATION University degree in chemistry or chemical engineering, or related field with significant experience in pharmaceutical development or manufacturing.
Skills Detail-oriented mindset with a focus on safety, quality, and continuous improvement.
Thinks and acts with a customer-centric approach.
Is intellectually curious and accepts continuous improvement.
Enables strategic focus by setting the right objectives prioritizing work and resources across the team and organization to improve impact.
Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and clients.
Proven experience in chemical operations, process development/manufacturing and scale-up in a CDMO or CRO setting.
In-depth knowledge of GMP regulations, quality systems, and regulatory requirements for pharmaceutical manufacturing.
Hands-on experience with analytical techniques, process optimization, and troubleshooting in organic synthesis.
What to expect The working environment is usually office and pilot plant based, although you may need to visit customers and suppliers.
On-call availability after agreed schedule, as needed.
Seniority level Mid-Senior level Employment type Full-time Job function Manufacturing Industries Pharmaceutical Manufacturing #J-18808-Ljbffr