Job Title: Executive / Senior Executive, Upstream Manufacturing (Biologics)
Company: Aragen Biologics Solutions
Location: Bommasandra, Bengaluru, India
Join Aragen Biologics Solutions:
Aragen Biologics Solutions is a pioneering force in the biologics sector, committed to innovative research and manufacturing. We are actively seeking skilled and passionate professionals to enhance our Upstream Manufacturing – Biologics department. This is a critical opportunity for individuals with expertise in mammalian cell culture and a strong commitment to quality. We have 4 immediate openings for dedicated team members to join our Bengaluru facility.
About the Role:
As an Executive or Senior Executive in Upstream Manufacturing, you will be instrumental in the execution, monitoring, and optimization of mammalian cell culture processes. This role demands a keen eye for detail and adherence to the highest quality standards in developing and producing cutting-edge biologic solutions. You will contribute significantly to our production capabilities and quality assurance.
Key Responsibilities:
Upstream Manufacturing Operations:
- Execute, monitor, and optimize mammalian cell culture processes from initiation to harvest.
- Operate and maintain advanced single-use bioreactor systems.
- Set up manufacturing systems, monitor process parameters diligently, and efficiently troubleshoot any operational issues during runs.
- Collaborate effectively with cross-functional teams to support process scale-up activities.
- Ensure strict adherence to Good Manufacturing Practices (GMP) and all relevant regulatory guidelines.
- Perform qualification activities for upstream manufacturing equipment to ensure operational readiness.
- Maintain accurate and detailed manufacturing records, ensuring audit readiness at all times.
Quality Management Systems (QMS) & Documentation:
- Initiate and thoroughly document deviations related to upstream processes, supporting robust quality control.
- Prepare, review, and submit comprehensive Batch Manufacturing Records (BMR).
- Prepare, revise, and meticulously maintain Standard Operating Procedures (SOPs) for all upstream activities.
- Handle and manage qualification documents for equipment and processes.
- Support investigations and perform root cause analysis for any non-conformances identified.
Qualifications:
- Experience: 2 to 6 years of relevant experience in Upstream Manufacturing, preferably within a biologics environment.
- Education: M.Sc. or B.Tech. in Biotechnology from a recognized institution.
- Skills: Proven expertise in mammalian cell culture, operation of single-use bioreactors, and a strong understanding of GMP principles.
How to Apply:
Interested candidates meeting the above criteria are invited to send their resume to Prashanth.Cherugad@aragen.com. Please include “Executive/Sr. Executive, Upstream Manufacturing” in the subject line of your email.
