As a Senior Executive in the Upstream Manufacturing Department located in Bengaluru, India, you will be responsible for various tasks related to Mammalian Cell Culture Upstream Processing. With a required educational qualification of BTech/MTech/MSc and 6-8 years of relevant experience, you will play a crucial role in the manufacturing operations. Your primary responsibilities will include managing vial thaw, cell counting, and seed expansion activities. Additionally, you will oversee media preparation, wave bioreactor, and SS bioreactor operations. It will be your duty to ensure proper documentation practices are followed, including maintaining Batch Manufacturing Records and Special Process Requirements. Furthermore, you will be accountable for the documentation of Quality Management Systems, such as deviations, change controls, and risk assessment documents. Your role will also involve managing facility maintenance in compliance with cGMP guidelines to ensure operational efficiency and adherence to quality standards. Overall, as a Senior Executive in the Upstream Manufacturing Department, you will play a critical role in ensuring the smooth functioning of manufacturing processes and maintaining high-quality standards in all operations.,
The Executive in Downstream Manufacturing department located in Bengaluru, India is expected to actively participate in the day-to-day activities of downstream processes. You will provide technical leadership to junior staff involved in downstream process activities. It is essential to be well-versed in AKTA Process systems and assist supervisors during critical activities such as tech transfer and scale-up. A minimum of 4-6 years of experience in downstream processing of Monoclonal Antibodies or Recombinant Therapeutic Proteins is required, along with educational qualifications of BTech/MTech/MSc. Additionally, experience in the scale-up of purification processes is preferred.,
Job Description You will be responsible for the following: - Maintaining accurate and reliable records including batch records and relevant documentation. - Following standard operating procedures and adhering to all safety and company policies. - Troubleshooting in case of any deviation from process/parameter. - Reviewing and interpreting data received from analytical functions. - Generating and compiling data. Qualification Required - Educational Qualification: BTech/MTech/MSc - Experience: 3-5 Years in Mammalian Cell Culture Upstream Processing,
As an experienced Engineer in the Biopharma industry, your role will involve the following responsibilities: - Reviewing engineering activities such as calibration, PM, breakdown maintenance, and utility operation to ensure compliance with written procedures for equipment and building infrastructure. - Participating in routine equipment breakdown workorder review meetings, assessing workorder reports for quality, and ensuring timely closure of workorders. - Supporting the annual review of equipment breakdowns and participating in remediation programs. - Reviewing calibration certificates of instruments and participating in calibration activities on the shopfloor. - Reviewing engineering design documents for equipment and utilities as a Subject Matter Expert (SME). - Reviewing SOPs, Preventive Maintenance checklists, calibration procedures, and IT procedures implemented at the site. - Providing support to the Engineering and IT departments by tracking, drafting, reviewing, and closing documents related to QMS elements like Deviations, Change Controls, CAPA, QRM, and audit commitments. Qualifications required for this role include: - BE/B.Tech degree with specialization in Mechanical or EEE - B. Pharm qualification You should have more than 6-8 years of experience, preferably in the Biopharma industry.,
As a Sr. Executive in the Upstream Manufacturing Department located in BENGALURU, INDIA, your role involves overseeing various key responsibilities in Mammalian Cell Culture Upstream Processing within the Manufacturing Department. Your qualifications should include a BTech/MTech/MSc degree along with 6-8 years of relevant experience. Role Overview: - Manage vial thaw, cell counting, and seed expansion activities. - Oversee media preparation, wave bioreactor, and SS bioreactor operations. - Maintain documentation such as Batch Manufacturing Records/Special Process Requirements. - Ensure compliance with Quality Management Systems by handling deviations, change controls, risk assessment documents, etc. - Supervise facility maintenance in accordance with cGMP guidelines. Qualification Required: - BTech/MTech/MSc degree. - 6-8 years of experience in Mammalian Cell Culture Upstream Processing. Kindly note that the job description did not include any additional details about the company.,