Ajim Shaikh

Ajim Shaikh Email and Phone Number

Biosimilar manufacturing Expert ||MES PAS-X II Downstream Processing Professional || Mammalian cell culture || Production Specialist at Dr. Reddy's Laboratories @ Dr. Reddy's Laboratories
hyderābād, telangana, india
Ajim Shaikh's Location
Hyderabad, Telangana, India, India
About Ajim Shaikh

As a dedicated biotechnology professional in downstream production, I bring a proven track record of contributing to production success in the biopharmaceutical industry. My expertise spans both mammalian and microbial cell culture, with a focus on the downstream processing of biosimilars such as Bevacizumab, Rituximab, and G-CSF.In my current role at Dr. Reddy's Laboratories, I manage the downstream processing of Bevacizumab and Rituximab in fully automated mammalian cell culture units. I excel in handling and optimizing SCADA and DCS systems for downstream processing, ensuring top-notch performance and efficiency. My proficiency extends to managing TFF systems (PALL) & AKTA process chromatography (Cytiva), and Blast freezer (KW Apparecchi).I have comprehensive exposure to Manufacturing Execution Systems (MES), specifically the Werum PAS-X suite, for controlling, monitoring, and executing batch processes. This includes overseeing batch release activities, executing, reviewing, and submitting batches for QA approval.Moreover, I have gained expertise in Electronic Batch Manufacturing Records (E-BMR) using Process-XE software, along with developing study protocols. My role also encompasses buffer preparation, depth filtration, diafiltration, ultrafiltration, various chromatography steps, and drug substance activities.Previously, I have contributed to Intas Biopharmaceuticals by specializing in the downstream processing of microbial cell culture for G-CSF production. My foundational training at Wockhardt Ltd. and Adora Products Pvt. Ltd. has provided me with a solid understanding of downstream techniques, quality control, and GMP standards.I am passionate about advancing biotechnological processes and am committed to maintaining high standards of quality and efficiency in biosimilar production. My skills in process automation, equipment handling, and cross-functional coordination have consistently driven production success and innovation in my roles.

Ajim Shaikh's Current Company Details
Dr. Reddy's Laboratories

Dr. Reddy'S Laboratories

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Biosimilar manufacturing Expert ||MES PAS-X II Downstream Processing Professional || Mammalian cell culture || Production Specialist at Dr. Reddy's Laboratories
hyderābād, telangana, india
Website:
drreddys.com
Employees:
15315
Ajim Shaikh Work Experience Details
  • Dr. Reddy'S Laboratories
    Production Specialist
    Dr. Reddy'S Laboratories Jul 2021 - Present
    Hyderabad, Telangana, India
    Large-Scale Mammalian Cell Culture: Perform downstream processing of biologics like Rituximab and Bevacizumab in a large-scale environment.Chromatography Processes: Operate and optimize various chromatography techniques including affinity, anion, and cation exchange chromatography.AKTA Systems: Manage operations on AKTA process systems (25 mm and 10 mm, Cytiva) and ensure optimal performance.Column Packing and Unpacking: expertise in column packing, unpacking, and column qualification.Filtration Systems: Expertise in Tangential Flow Filtration for separation and concentration processes.CIP, PHT, SIP & FIT: Lead cleaning-in-place (CIP), post-harvest treatment (PHT), sterilization-in-place (SIP), and filter integrity testing (FIT) operations to ensure quality and compliance.Process Qualification: Successfully execute Process Performance Qualification (PPQ) batches, particularly for Rituximab.Manufacturing Execution System (MES): Expertise in Werum PAS-X MES suite for process control, monitoring, and batch execution of Bevacizumab.MBR and Batch Release: Submit Manufacturing Batch Records (MBR) and support batch release activities in compliance with regulatory requirements.
  • Intas Pharmaceuticals Ltd. (Biopharma Division)
    Executive
    Intas Pharmaceuticals Ltd. (Biopharma Division) Jun 2019 - Jul 2021
    Ahmedabad, Gujarat, India
    Downstream Professional Worked for microbial base biosimilar like G-CSF, Romiplostim and Ranibizumab .Exposure to small scale and large scale production and expertise in SCADA & DCSI have hands on experience on preparation of E BPR and its execution by using process Xe software.Good handling of equipment like AKTA pilot, AKTA process, and Tangential flow filtration.Well versed with buffer preparation activities in small scale and large scale.
  • Wockhardt Ltd.
    Production Officer
    Wockhardt Ltd. Jul 2018 - Jun 2019
    Aurangabad Area, India
    Worked in Downstream for microbial manufacturing for insulin yeast.Involved in manufacturing process of insulin As mentioned below.I have involved from conversion to RP-HPLC steps in fully automated facility wher I learn SCADA & DCS. Learn separation process such as medium pressure liquid chromatography , Reverse phase high performance liquid Chromatography, Crystalisation, Centrifugation and Precipitation. Conversion of pro Insulin to crude Insulin.,Learn about Centrifugation, enzyme addition, and hydrolysis reaction.
  • Adora Product Pvt Ltd
    Trainee
    Adora Product Pvt Ltd Oct 2017 - Apr 2018
    Aurangabad, Maharashtra, India
    •Worked as trainee in IPQC (in process quality control) Overall completed training in quality control department and gained experienced

Ajim Shaikh Education Details

Frequently Asked Questions about Ajim Shaikh

What company does Ajim Shaikh work for?

Ajim Shaikh works for Dr. Reddy's Laboratories

What is Ajim Shaikh's role at the current company?

Ajim Shaikh's current role is Biosimilar manufacturing Expert ||MES PAS-X II Downstream Processing Professional || Mammalian cell culture || Production Specialist at Dr. Reddy's Laboratories.

What schools did Ajim Shaikh attend?

Ajim Shaikh attended M.g.m's Jawaharlal Nehru College Of Engineering.

Who are Ajim Shaikh's colleagues?

Ajim Shaikh's colleagues are Rama Rao Poola, Dr. Phaneendra Gutala, Syed Mohammed Abbas, Majji Sandhya Rani, Santhu Gade, Bksv Venkateswara Rao, Amrit Parashar.

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