Manager

Job Description

We are Hiring!!! Cell Line Development (CLD) Position: Manager – Mammalian cell culture (CLD), Upstream bioprocess team in developing, optimizing, and scaling processes to produce recombinant proteins, monoclonal antibodies (mAbs), or viral vectors (01 vacancy) Department: – Mammalian cell culture (CLD)- Technical Oversight, Operational Strategy & Regulatory Oversight – Biologicals Experience: 8 – 12 years Location: Genome Valley, Hyderabad, India Qualifications: M.Pharm/B.Pharm/M.sc (Biotechnology/Biochemistry) 📧 Send your profile to: sreddy@bachwellpharma.com, bachwellpharma@gmail.com, hr@bachwellpharma.com Core responsibilities: 1. Technical & Process Oversight At its core, your job is to ensure that the cells (typically CHO, HEK, or BHK) stay healthy, productive, and uncontaminated. Process Development (PD): Overseeing the optimization of media formulations, feed strategies, and bioreactor parameters (pH, dissolved oxygen, temperature). Scale-Up Operations: Transitioning a process from a 5L benchtop bioreactor to 500L or 2,000L production scales without losing “titer” (yield) or product quality. Troubleshooting: Leading “root cause analysis” when a batch fails due to unexpected cell death, low productivity, or metabolic shifts (e.g., high lactic acid buildup). Technology Transfer: Managing the hand-off of processes from the R&D team to the Clinical or Commercial manufacturing teams. 2. Operational & Team Leadership You are responsible for the “rhythm” of the lab or suite. Resource Planning: Scheduling “seed trains” (the sequential expansion of cells) to ensure that bioreactors are ready exactly when needed. Budgeting: Managing the high costs of specialized media, single-use bioreactor bags, and expensive analytical equipment. Mentorship: Training associates on aseptic techniques. In mammalian culture, a single stray bacteria or mycoplasma can ruin weeks of work and cost hundreds of thousands of dollars. 3. Quality and Regulatory Compliance Since these cells produce medicine for humans, the environment is strictly controlled. GMP (Good Manufacturing Practices): Ensuring all work meets the rigorous standards of the FDA or EMA. Documentation: Reviewing Batch Production Records (BPRs) and Standard Operating Procedures (SOPs). If it wasn’t documented, it didn’t happen. Deviations and CAPA: Investigating any deviations from the protocol and implementing Corrective and Preventive Actions (CAPAs) to ensure the mistake isn’t repeated.