Young Professionals Opportunity in Life Sciences at DALC – Navi Mumbai

Job Responsibilities

1) Manufacturing Operations and Project Execution

• Ensure manufacturing processes are conducted per SOPs and project timelines.
• Plan and execute product manufacturing with a focus on operational efficiency and overcoming process hurdles.
• Regularly engage with operations, QA departments, and other support functions to meet targets.
• Strive for optimal batch yields and effective resource utilization, including process units and utilities.
• Operate bioreactors, chromatography, TFF, and CIP systems; experience with DCS control systems is an added advantage.
• Handle both upstream (e.g., seed and production bioreactor operations, media and buffer preparation) and downstream (e.g., centrifugation, microfiltration, ultrafiltration) processes.
• Manage scale-up and scale-down processing for comprehensive manufacturing adaptability.

2) Review and Monitoring

• Prepare and manage cleaning/disinfectant solutions and maintain the cleanliness of areas/equipment as per schedule and SOPs.
• Ensure manufacturing processes are executed per SOPs/guidelines with proper documentation and good documentation practices (GDP).
• Periodically update and revise documents to align with cGMP standards and QAD requirements.
• Evaluate production schedules for efficient goal accomplishment and supervise team members to meet performance standards through leadership and training.

3) GMP Compliance, Validation, and Audit Readiness

• Coordinate and support the timely completion of calibration, preventive maintenance, and validation of process units.
• Adhere to safety, GMP, and sanitation policies.
• Ensure readiness for GMP, FDA, WHO, and international audits, and assist with the preparation of Batch Manufacturing Records (BMRs) and Batch Packing Records (BPRs).
• Prepare and execute validation protocols to meet industry standards.

Education Requirement

• Qualifications: Bachelor’s or Master’s degree in Science or B.E. in Biotech Engineering.

Experience Requirement

• Experience: Minimum of 0-1 year of relevant experience.
• Demonstrated ability to supervise, lead, and build relationships across all company levels.

Skills & Competencies

• Technical Skills:
  • Hands-on experience with bioreactors, chromatography, and other bioprocess systems.
  • Proficiency in both upstream and downstream bioprocessing operations.
  • Knowledge of DCS control systems is preferred.
• Behavioral Skills:
  • Strong leadership capabilities to coach and train employees.
  • Effective supervision and problem-solving skills.
  • Ability to maintain focus on GMP and safety standards.

Safety Requirements

• Conduct activities related to Occupational Health, Safety, and Environmental Management in line with SOPs.
• Maintain awareness of the consequences of not adhering to these standards.

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