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Worked with fully automated Stainless-steel Bioreactors of scale 200

Hyderabad, Telangana, India
December 26, 2020

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Flat number ***

Sai srinivasam mahalaxmi

Old Alwal Hyderabad 2428591b


Professional Profile

Experienced Manufacturing Specialist brings a combination of strong leadership skills and the ability to motivate team. Possesses a strong understanding of workplace safety regulations and ensures staff always follows standards. Brings more than 6 years of manufacturing experience in Mammalian Cell Cultures and a master’s degree in biochemistry. Experience

Sr.Executive, Virchow biotech pvt limited HYDERABAD Telangana state, December-2020 to TILL date Executive, VENAGRO PVT Limited, HYDERABAD, Telangana state. November 2018 – deceber-2020. Jr. Executive, Bharath biotech pvt. Limited, Genome valley Hyderabad, Telangana State, sept 2014 – oct 2018. Professional Experience

Worked with fully automated Stainless-steel Bioreactors of scale 200L.

Expertise in operating Single Use Bioreactors (Make: icellis from 500 L Scale to 2000 L Scale).

Worked on K-prime chromatography purification.

Cellufine sulphate resin purification for viral vaccine.

Cellufine-SPA-HC resin purification for Mab.

Media, Buffer preparations and Aseptic Filtrations.

Leading Process Deviations, CAPA’s, and Change controls.

Leading Qualifications & Validations of downstream Process Equipment’s.

Preparation, review of Manufacturing Batch Records, SOPs.

Preparation, review and approval of Qualification documents (URS, VA, VP, SLIA, CLIA, DQ, RA, FAT, SAT, IQ, OQ, PQ, IOQ, VSR).

Successfully qualified Single Use Bioreactors.

Expertise in software operation integrated with Bioreactors, incubators and media preparation vessels.

Managing team members, Team shifts and shift activities.

Coordination with cross functional departments and external vendors for timely equipment maintenance, calibrations etc

Coordination with QC and QA for smooth functioning and timely closure of documents.

Collaborating with MSAT and operational team members to revise SOPs and batch records and other operational related documents.

Following cGMP and GDP practices by performing all activities in safe and compliant manner.

Successful execution of commercial manufacturing of batches without any contamination issues till date.

Supervising all aspects of respective areas of operations.

Comfortable working in fast-paced dynamic environments.

Conducting technical trainings and guidance to the new recruits and team members.

Team Player and ability to work on own initiative.

Purchase requisitions and contacting vendors for process equipment’s.

Develops work schedules for department by assessing priorities, workload and available resources.

Develops and motivates cost-effective alternatives and improvements to production process

Strong understanding of the pressures associated in leading a production team. Equipment’s handled

Single Use Bioreactors (ICELLIS – 200L, 1000L integrated with Finesse TruBio DeltaV and Wonderware software’s).

Stainless steel Bioreactors (Sartorius - 500L).

K-prime purification.

Tangential flow filtration. (TFF system)

0.2-micron filtration.

Formaldehyde inactivation.

Media preparation vessel (1000L), Media & Buffer preparation vessel ( 1500L)

Incubators – Kuhner, Infors.

Filter Integrity – Pall, SARTORIOUS.

Product’s handled

Japanese encephalitis, Rabies, H1N1

Audit’s faced



Master of Science in Biochemistry from Bhavans new science College, Osmania University, Hyderabad, India.

2011 – 2013.

Bachelor of Science in Microbiology, Biochemistry and Chemistry from HRD Degree College, Osmania University, Hyderabad, India.

2007 – 2010.

Technical Knowledge

Good command on computers and operating systems, MS-Office etc certified Languages



INTERESTS: Exploring Places, Travelling, Knowing new cultures, cooking. References

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