Junior Executive/Executive-Production Biotech

Company Description:

Established in 1951, Fermenta Biotech Limited (FBL) is a global Vitamin D3 manufacturer with state-of-the-art R&D and manufacturing facilities in Thane, Kullu, and Dahej. FBL also offers niche APIs, enzymes for antibiotic synthesis, and environmental solutions for wastewater management.

www.fermentabiotech.com

Summary:

Fermenta Biotech Limited is looking for an experienced and highly motivated Jr. Executive / Executive to join our Biotech Division. The ideal candidate will have hands-on experience in both upstream and downstream processes, with specific expertise in fermentation and critical shift process handling. This role is integral to the production of high-quality pharmaceutical APIs, and the candidate must possess knowledge of cGMP standards, documentation practices, and sterilization processes. The successful candidate will play a key role in supporting the production team and ensuring the smooth operation of biotech manufacturing processes.

Roles & Responsibilities:

• Upstream and Downstream Process Handling: Manage and monitor both upstream (fermentation) and downstream (purification, recovery, etc.) processes to ensure the smooth production of biotechnological products. Operate and maintain equipment involved in these processes.
• Fermentation Expertise: Operate fermentation systems, monitor fermentation parameters, and ensure optimal conditions for microbial growth and product yield. Handle fermentation media, inoculation, and harvest processes.
• Dry Heat Sterilization: Perform dry heat sterilization for equipment, media, and related items as per SOPs to ensure sterile conditions are maintained in the production environment.
• Critical Shift Process Management: Oversee critical shift operations during fermentation and other biotechnological processes. Ensure processes are running according to predefined protocols and handle any process deviations or issues during shifts.
• Compliance with cGMP & Documentation: Ensure all activities are conducted in compliance with current Good Manufacturing Practices (cGMP). Maintain and update necessary documentation, including batch records, process logs, and compliance reports.
• Troubleshooting & Process Optimization: Troubleshoot any issues or deviations in the production processes and provide solutions. Assist in process improvements and optimization activities to enhance production efficiency and yield.
• Safety & SOP Adherence: Ensure all safety protocols and standard operating procedures (SOPs) are strictly followed during biotech production activities. Participate in training sessions to stay updated on safety, regulatory, and technical advancements.
• Cross-functional Collaboration: Collaborate with other departments such as Quality Control (QC), Quality Assurance (QA), and Maintenance to ensure the production process runs smoothly and meets the required standards.

Qualification & Skill Requirements:

• Graduate in Science (e.g., Biotechnology, Microbiology, Biochemistry, or related field).
• Minimum 3 years of proven experience in biotech production, specifically in fermentation and downstream/upstream processing within the pharmaceutical/API industry.
• Extensive experience in fermentation processes.
• Hands-on experience with downstream and upstream processing techniques.
• Thorough understanding of cGMP regulations and documentation requirements.
• Proficiency in dry heat sterilization and handling critical shift processes.
• Knowledge of relevant equipment and instrumentation.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work effectively in a team environment.
• Strong attention to detail and accuracy.
• Ability to work under pressure and meet deadlines.
• Adaptability to changing priorities and tasks.