Upstream Manager

From Mabxience, a company specialized in the development and manufacture of biosimilar medicines, we are incorporating a Upstream Manager for our plant in León.

Global responsibilities

This role is responsible for planning, coordinating and organizing production operations corresponding to UpStream (UPS) process activities, following the applicable operating procedures and requirements of GMP regulations.

He/she will supervise the production operations corresponding to your department, including all cell culture activities and auxiliary activities, intermediate product handling, as well as cleaning and availability of materials, raw materials and equipment.

He/she will be responsible for leading all activities of the UpStream (UPS) department, providing technical and professional support to your team. Under the supervision of the Manufacturing Manager, you are responsible for implementing and maintaining a robust, repetitive and controlled production process, in accordance with the applicable operating procedures and manufacturing guidelines.

To do this, he/she must establish and maintain the flow of process activities, considering the objectives and priorities established within the manufacturing plan, while ensuring the safety of the product, process, facilities and personnel in charge. In this role, he/she must ensure that the development of activities complies with the established quality standards.

Participate in the management of change controls, deviations and CAPAs, collaborating with the other departments involved in these activities.

Propose activities and plans to improve efficiency and the use of available resources.

Promote operational excellence, assessing the training and coaching needs of the Upstream production team to ensure that the team's operational capabilities are adequate and up to date.

Specific responsibilities

1. Supervise the transfer of Cell Culture methodologies from Research and Development to Production.
2. Implement and maintain production programs, training and human resources requirements.
3. Provide general supervision of the work group, assigning specific tasks and checking the development of the work at regular intervals of time.
4. Ensure proper use, cleaning, sanitization, maintenance, validation, calibration and certification of all equipment used in your department.
5. Conduct or review investigations and implement a follow-up plan for the implementation of corrective and preventive measures corresponding to each deviation generated.
6. Interact with equipment suppliers chosen for routine use in production activities.
7. Interact with the planning, validation, MQA, R&D, etc. departments.
8. Creation and review of the documentation applicable to the plant (Operating Procedures, Batch Records, etc.).
9. Elaborate from the process descriptions and taking into account the work procedures the Batch Records necessary for the production of the different products implemented.
10. Make modifications and updates to the Lot Records due to deviations, improvements or other causes.
11. Ensure the availability of the right Batch Records for production according to your need.
12. Collection and definition of the justifications for the changes of the Production Batch Registers.
13. Review and approve batch records in accordance with the program of need for them.
14. Ensure the appropriate level of training/training of operators and other coaches.
15. Request requests for maintenance work and authorize their completion.
16. Requests for change of facilities (CR) and requests for purchases.
17. Control the complete and strict compliance with the applicable legislation and cGMP regulations.
18. Maintain an activity that respects the environment that meets the current standards of the company and the requirements in terms of safety, hygiene and environment.
19. Contribute to the creation of a work environment that encourages the employee to be involved in achieving excellence in production, customer focus, quality, inventory and SHE.
20. Work together with your immediate superior in achieving the objectives of the process and compliance with the budget.
21. Actively collaborate in the definition/review of new products and processes of the plant.
22. Present and respond accurately before the different audits and inspections of the corresponding regulatory agencies.
23. Participation in the working groups assigned to each client with attendance at meetings, teleconferences and other activities related to it.
24. Organize the staff structure and the quadrants of the Upstream Department for the correct performance of the Department's activities.

Personal requirements and skills

• Education: Degree in a Life Science matter.
• Languages: Spanish and Fluent English.
• Experience: +5 years of experience in a similar position.
• Specific knowledge: Knowledge of cGMP's.
• Travel: Availability to travel.
• Personal skills: Good level of communication and organizational capacity.

We offer a permanent contract to join a growing pharmaceutical company.

• Life and accident insurance.
• Free company canteen.
• Free online training platform.
• Free online library.
• Social, physical and emotional well-being platform.

mAbxience is committed to equal opportunities. We do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.
#J-18808-Ljbffr

---