Assistant Manager Team Lead

Telangana, India +91-812******* / 994-***-**** ******.****@*****.***

PRODUCTION DEPUTY MANAGER – BIOTECHNOLOGY

Resourceful and result-oriented Production Manager with 14+ years of experience in the Upstream Process in handling of Pertussis, HIB, Diphtheria, and Typhoid Vaccines, and Implementation of Analytical techniques & Bioprocess methods. Incorporate excellent project management skills; troubleshoot process and instruments GDP & C- GMP documentation, and cleaning and process validation process of equipment and aseptic process simulation.

Fermentation Procedures

Document preparation

Aseptic Techniques

Sampling Procedures

Media Preparation

Qualification of fermenters and process vessels

Qualification of continuous centrifuge

UV-Visible Spectrophotometer

Sterilization Techniques

Downstream Process of Diphtheria

ASSISTANT MANAGER JAN 2025– Till date

Bharat Biotech International Limited,

Hyderabad

Team lead for Hepatitis-B antigen manufacturing

DEPUTY MANAGER Aug 2023 –DEC 2024

Panacea Biotec Ltd, Lalru, Chandigarh

Team lead for Diphtheria bulk and pertussis antigen manufacturing

ASSISTANT MANAGER Dec 2018 – Feb 2023

Sanofi Health Care India Private Limited,

Hyderabad

ASSISTANT MANAGER Dec 2009 – Dec 2018

Biological E Limited, Hyderabad

Handled Westfalia (Continuous Centrifuge operation (CSC-20 and CSC-15) and Beckman centrifuge.

Lead IPQC activities, including Lf testing, purity, sterility, and procurement of raw materials for the production batch.

Document preparation like BMRs, SOPs, Protocols, Record sheet templates, Cleaning and process validation process for routine manufacturing.

SHAIK SHERIFUDDIN Page 2 of 2 +91-994**-***** / 812**-***** ******.****@*****.***

Involved in IQ, OQ, and PQ of Fermenters (30L, 150L and 2600L)

Pre-seed/seed preparation techniques.

Calibrate Fermenter pH, DO2 probes, weighing balance, and Peristaltic pumps.

Complete media preparation includes Diphtheria-Papain Digest Media and NZ-Amine Media, pertussis media includes Verwey and Cohen wheeler media.

Steer the calibrations and usage of pH meters, Conductivity meters, Watson-Marlow pumps, and Master flex pumps.

Auto SIP (Sterilization in Place) and Auto CIP (Cleaning in Place).

Manage Sartorius 70L, 600L, 1200L, Sciences 1250L, Biozeen 75L 2600L Tofflon capacity fermenters.

Microfiltration with 0.22 microns and Ultrafiltration with 30kd, 100kd.

Handled Aseptic connectors, Aseptic disconnector, Spinner vessel at the seed stage, and Shipper's vessel at final stage for storage of bulk.

Train on production processes like clarification, concentration diafiltration (TFF), and process steps like sterile filtration of diphtheria vaccine.

Standardize heat inactivation and pooling activity of pertussis bulk antigen.

Preparation of SOPs related to the production process and launch in GEODE, along with personnel training.

Coordinate with the QC department for testing of in-process production samples, and with the process development team for product development.

Involved in synthetic media process validation batches with NZ-amine media for diphtheria bulk vaccine manufacturing, and process validation batches of Typhoid vaccine.

Participated in SAP-related activities like posting consumables and raw materials.

Drive internal activities like GEMBA WALK, SLT, and +QDCI.

Maintain production facility as per cGMP guidelines.

Oversee the Pilot Plant projects for scale-up.

Orchestrate cGMP Documentation practices and control.

Lead the documentation of BMR and other daily reports as per cGMP, and preparation of MCB & WCB for Diphtheria and HIB.

Filter Integrity techniques and sterile bulk filtration through 0.22µ filters.

Master of Science – Biotechnology Ponnaiah Ramajayam College, Bharathidasan University, Tiruchirappalli 2007 Bachelor of Science – Biotechnology, Zoology and Chemistry Kavitha Memorial Degree College, Kakatiya University, Warangal 2005

Identified the root cause of aseptic process simulation failure and resolved it.

Participated in and handled the biosafety activities like MCB and WCB preparation and successfully filling the vials aseptically.

Involved in three process validation batches of Typhoid.

Participated in External customer Audits for WHO.

Involved in the process development process of Diphtheria and HIB vaccine from working seed bank preparation to final bulk.

Assisted GQA Sanofi Audit in 2019 and 2020.

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