Manufacturing Lead – Probiotics
3 months ago
Job Summary:
We are seeking an experienced Manufacturing Lead with a strong background in fermentation processes, particularly within the probiotics industry, to spearhead the establishment and scaling of our fermentation facility. As a newly launched company in the probiotics space, we are looking for a candidate with both technical expertise and hands-on experience in setting up and scaling fermentation operations, who can guide us from facility setup to full-scale production. This is a unique opportunity to be part of a core team, laying the foundation for a state-of-the-art probiotics manufacturing facility.
Key Responsibilities:
• Facility Setup:
• Lead the design, setup, and commissioning of the fermentation facility, including equipment selection, installation, and validation.
• Work closely with engineers, consultants, and vendors to ensure that all fermentation-related infrastructure meets industry standards and regulatory compliance.
• Develop and implement operational procedures for the fermentation unit.
• Fermentation & Manufacturing Operations:
• Oversee daily fermentation operations, ensuring the efficient production of probiotics, including Lactobacillus, Bifidobacterium, and Saccharomyces species.
• Manage and optimize upstream fermentation processes from small to large-scale production (including 15 cubic meter capacity), ensuring yield and quality consistency.
• Scale-up fermentation processes from pilot to commercial scale.
• Process Development & Scale-Up:
• Lead the fermentation scale-up efforts, including optimizing bioprocess parameters and ensuring smooth transitions from lab-scale trials to commercial production.
• Develop robust protocols for the fermentation process, including monitoring critical process parameters, inoculation procedures, and media optimization.
• Implement continuous improvement initiatives to enhance efficiency, reduce costs, and increase production capacity.
• Quality Control & Compliance:
• Ensure that all fermentation processes comply with cGMP, ISO, and other relevant industry standards for probiotic production.
• Work with the Quality Assurance team to maintain rigorous quality control throughout the fermentation process.
• Ensure proper documentation, batch records, and regulatory submissions related to fermentation and scale-up activities.
• Team Leadership & Collaboration:
• Manage a cross-functional team of engineers, biotechnologists, and production staff to achieve project goals.
• Train and mentor junior team members, providing technical guidance on fermentation practices and production processes.
• Collaborate with R&D, quality assurance, and supply chain teams to ensure smooth operational integration and product quality.
• Equipment & Maintenance:
• Oversee the maintenance, calibration, and troubleshooting of fermentation equipment.
• Implement best practices in preventive maintenance to minimize downtime and ensure the longevity of fermentation equipment.
Key Qualifications:
• Bachelor’s or Master’s degree in Biotechnology, Microbiology, Bioprocess Engineering, Chemical Engineering, or a related field.
• 7+ years of experience in fermentation, preferably with probiotics products.
• Proven experience in setting up and scaling fermentation facilities from scratch.
• Strong understanding of upstream fermentation processes, bioreactor operation, and process optimization.
• Experience in managing large-scale fermentation systems (up to 5 cubic meters and above).
• Familiarity with cGMP and other regulatory standards in the probiotic or biopharmaceutical industry.
• Hands-on experience with bioreactor equipment, drying processes (lyophilization, spray drying), and downstream processing techniques.
• Excellent leadership and project management skills, with the ability to collaborate across teams and departments.
• Strong problem-solving abilities and a focus on process improvement.
Preferred Qualifications:
• Experience in probiotic manufacturing or similar microbial fermentation processes.
• Knowledge of ISO certification processes and regulatory guidelines for probiotics production.
• Strong understanding of scale-up challenges and bioprocess development.
Why Join Us:
• Be part of a groundbreaking team in a newly launched probiotics manufacturing company.
• Play a pivotal role in the establishment of a state-of-the-art fermentation facility.
• Opportunity to grow with the company as we expand our operations and product offerings.
• Competitive salary and benefits package.
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