MSAT Engineer

Our client belongs to the food production industry who is cultivating the future of sustainable seafood by crafting delicious, nutritious, affordable cultivated fish that is better for the health, the oceans, and our planet. They are weaving together the deep wisdom of the oceans with modern innovation to develop reasonable and healthy seafood that provides a sustainable alternative to the harmful impact of traditional fishing practices.

Responsibilities:

• Demonstrates expertise in Scale Up and Technology transfer of multiple animal stem cell product from pilot to Commercial scale (upto 1KL Stainless steel bioreactor)
• Co-ordinates with the R&D team (or client for tech transfer of processes) to ensure processes for GMP manufacture are robust, scalable, and suitable for the GMP specific equipment.
• Application of cutting-edge technologies (perfusion process) in manufacturing setup and evaluation of different manufacturing modalities.
• Ensures that all tech transfers into operations are controlled and implemented within GMP regulatory guidelines.
• Ensures the availability of appropriate SOPs and documentation are provided to enable right first time and on time delivery of customer tech transfer projects.
• Leads in consistent and document compliance with all relevant Safety, Health and Environmental (SHE), Good Manufacturing Practice (GMP), Data Integrity, quality and best practice requirements.
• Technical point of contact (PoC) for clients for technology transfer into GMP manufacture and strong understanding on Upstream process, Process analytical tools (PAT) and analytical testing.
• Works closely with other departments including R&D, GMP Operations, bioengineering, and procurement as tech transfer lead to support the transfer of new processes and products into inhouse / client’s GMP manufacturing facilities.
• Leads in strategic resource and capacity planning for the site.
• Coaches junior team members to deliver high quality technical input for transferring production processes to GMP manufacturing.
• To keep up to date with regulatory guidelines to ensure suitability of processes for GMP and author regulatory documents for submission to Regulatory agencies (USFDA, EMA, MHRA) for animal stem cell products along with query response to agencies.
• Utilize technical knowledge to lead to process deviation investigations, impact assessments and reports.
• Supports GMP Operations and Bioengineering with fit assessments/gap analyses of equipment, facilities and processes

Requirements:

• Hands-on experience with stainless steel production bioreactors operation, maintenance, and related control software such as Sartorius/Cytiva/Tofflon/Truking or similar systems is a must.
• Experience in tech transfer of fermentation production processes - fed batch, perfusion and continuous fermentation.
• Experience with process scale up and scale down is a must.
• Developing different approaches to manufacturing processes
• Implementing new technologies and approaches to develop new products, improve efficiency and scale up the production of cultivated food
• Proven experience independently troubleshooting fermentation production batches.
• Actively engage in safety risk assessments and process risk assessments to identify mitigations and solutions to problems which may adversely impact the process.
• Material assessments and bill of materials for use in GMP manufacturing.
• Contribute to writing and reviewing process descriptions, equipment SOPs, process change controls, process risk assessments, batch manufacturing records and other documentation relevant to GMP manufacturing.
• Supervision/management of team members and Effective organization, communication, and leadership skills
• Ability to adjust to dynamic environment of start-ups and willingness to assist other departments.

Good to have Skills:

• Previous experience working in a start-up/established, biopharma/ food business is a plus. 

Educational qualification:

• Ph.D. in Chemical Engineering, Biochemical Engineering, Bioengineering, Biotechnology or Microbiology, Bioprocess development, Biotechnology or related field, with 10+ years or M.Sc. with 12+ years of relevant industrial hands-on experience