Required Sr. Executive- Production-mAbs ( Upstream)

Virchow Biotech Pvt Ltd requires Sr Executive -Production-mAbs (Upstream) for Hyderabad location.

Details are Provided below

1. Designation: Sr Executive

-Production-mAbs (Upstream)

2. No. of Vacancies: 2

3. Qualification: M. Sc or M. Pharma (LifeScience's)

4. Experience: 6 to 9 years

5. Budget: Based on their core competency and current CTC

6. Job Description:

1) Expertise in Upstream unit operations (CHO based mammalian expression systems) Handle mAb process for multiple products.

2) Strong Hands on experience with SS and SUB (Up to 2000 L scale) Exposure to handle of Bio-similar proteins and mAbs projects in cGMP area.

3)Sound knowledge and awareness of GMP controls, Quality systems and regulatory aspects Experience on risk assessment tools and change

management.

4) Experience on the Equipment Qualification and commission aspects

5)Supervise all upstream manufacturing activities in the 2KL cell culture facility with SS and disposable Bioreactors.

6)Plan daily upstream execution activities from media preparation, vial thaw to harvest.

7) Drive the process upstream and downstream deviations /investigations and closure. Planning of raw material /consumables management for production campaign along with PPIC team.

8) Monitor Batch process operation /unit operation (including CIP, SIP and preparation upstream accessories), close monitoring of batch performance and data.

9)Follow and practice on-line documentation all the time. Drive the qualification activities for all upstream and downstream equipment's. Follow CGMP practices during the manufacturing activity and operations associated activities with QA, QC and EAM.

7. Apply on following mail id

Regards, P. Raghurami Reddy, Asst General Manager-HR, raghu@virchowbiotech.com, Virchow Biotech Pvt Ltd, Hyderabad.