Process Development Manager
The company
Our client is a Contract Manufacturing Organization. They are specialized in development and manufacture of cellular therapy products and biologics for clinical trials and commercial phases in GMP conditions.
Hierarchy
-    The position reports to the Plant Director.
-    The position has direct reports: Upstream Process Development (USP) Technician and Downstream Process Development (DSP) Technician.
Tasks/Key Results Areas:
-    Responsible for managing the department, both in terms of materials, equipment and human resources, in order to meet the sales program in the areas of Development of USP and DSP
-    Collaboration with experts from USP and DSP Development to prepare weekly production schedule. Performing weekly monitoring of manufacturing development and complete control records of key indicators for the proper development of the department
-    Collaborate with the Technical Services team to ensure proper transfer of technologies and propose actions to improve the quality, cost, performance, time and safety of workers and the environment improvements
-    Responsible for reviewing the reports of developmental milestones agreed with customers
-    Participate in the preparation of bids for customers in collaboration with the Business Development team
-    Responsible for the coordination of investments detected in the area of business development.
-    Responsible for the performance evaluation of department personnel
-    Responsible for monitoring cost control in the Department of Development in order to meet company objectives
-    Ensure compliance with the quality standards established for the Department of Development.
-    Ensure proper maintenance of facilities, ensuring that they operate according to the manuals provided by the manufacturer
-    Form part of the design team and commissioning of new facilities
-    Participate in meetings and HAZOP risk analysis process.
-    Ensure that SOPs are kept current and the area's labour policies necessary to ensure compliance with quality standards Process Development department
-    Ensure proper execution of the operations proper to Development Process: from clonal selection to the formulation of the active principle; use and maintenance of equipment; processes of bacterial fermentation, cell culture, filtration and diafiltration processes with depth filters and FFT's; viral inactivation and removal; chromatography with FPLC (ÄKTA type).

Compensation package
-    To be negotiated: very attractive salary and fringe benefits.
Location of the position
-    The position will be based in its Spanish headquarters.

Profile
Qualification
-    Bachelor in Biology / Molecular / Biochemistry / Biotechnology / Pharma / Chemical Biology, Chemical Engineering
Additional Qualification:
-    Doctor in Microbiology, Biology, Biotechnology.
-    Training in GMP and GMP environments
-    Specific training in Management and Human Resources Departments
-    Extensive knowledge of office technology, statistical data analysis, design of experiments, VISIO.
-    Unicorn programming (preferably 5/6)
-    Handling Equipment Chromatography FPLC (ÄKTA PILOT, ÄKTA READY)
Language skills:
-    Fluent English is mandatory, both spoken and written.
Experience
-    Proven experience in the biotechnology industry in the area of Process Development in positions in which they have had to manage a team of people
-    Experience in developing processes that will subsequently be scalable to plant.
-    Experience in high efficiency plants and technical requirement.Apply now