Satyanarayana Raju
Senior Technical Lead Pharma
Chennai
Summary
To take a challenging position to contribute and grow in the pharmaceutical industry to utilize the technical, interpersonal and leadership skills in achieving the desired targets
A competent professional with 11+ years of experience in: ~ Pharmaceutical production & Quality management~ Process enhancement & Team management Knowledge of the implementation of various techniques and quality/safety standards for improving operations An effective communicator with excellent relationship building & interpersonal skills. strong analytical, problem-solving abilities; possess a flexible &detailed oriented attitude
Overview
12
12
years of professional experience
Work History
Senior Technical lead
HCL technologies
Chennai
04.2024
- Manage and mentor the Pharma cost management team through routine review of technical results, coaching, training, and helping to create reusable templates for customer presentation
- Contribute to project timelines and cost structures
- Be the main point of contact for the program with the customer, drive and manage the relationship with the customer to expand current service and identify new opportunities in the organization
- Performing 'Should Costing' of procured chemicals and/or biologics for the customer by mapping the end-to-end manufacturing process, equipment used, labor, capital investment and other operational costs
- Expertise in engineering judgement for key assumptions like step yield, % loss, mass and material balances, energy balances, and % recovery for the various process steps
- Ensure the team members are making reasonable engineering assumptions to arrive at the should-cost
- Drive Pharma MFG engineering business by identifying other potential services (eg
- Process transfer, tech transfer, MFG technical writing, etc) that can be offered by the team based on their skill level and experience.
Assistant Manager
Eugia Pharma specialties UNIT-III (Aurobindo Group)
Hyderabad
05.2018 - 04.2024
- Planning and supervising of daily production manufacturing and fill finish activities
- Intimate understanding of chemical manufacturing processes and synthesis of Drug
- Assist in improving standards of manufacturing by explaining drug chemistry and necessity of producing quality product of API manufacturing for patients' safety
- Worked closely with plant leads and R&D experts in process optimization and development
- Indenting receiving cross verifying of raw materials with batch records
- Evaluate alignment with internal standards and relevant regulatory requirements
- Planning of process activity and maintaining manpower as per the requirement
- Accurately evaluate equipment readiness, facility infrastructure, and documentation controls
- Ensure compliance during manufacturing and throughout production process of APIs
- Preparation of BMR and BPR as per the MFC and regulatory requirements
- Preparation and execution of validation protocols
- Engage with cross-functional teams to support product development
- Review and approval of process related SOPs with pictorial representation
- Working exposure in TRIMS (training information management)
- Working exposure in QMS (quality management system) for change controls CAPA's and deviations review and approval
- Working exposure in DMS (Document Management system) for preparation of SOPs
- Preparation of FMEA's (Failure mode Effective analysis) risk assessment and investigation reports regarding Drug manufacturing process
- Work experience in operation and execution of validation process of equipment's manufacturing vessels, reactors, washing and Depyrogenation tunnels and homogenizers and area
- Active participation and successful completion of customer audits and USFDA audits
- Handling the Pilot Plant projects for scale up, exhibit, PV, commercial batches
- Attending for trainings like on job, cGMP, external and giving trainings on process related SOPs as per the schedule/training matrix
- CGMP Documentation practices, control and initiation of quality notifications
- Responsible for review and online completion of documentation like log sheets and BMRs and BPRs
- Responsible for DQ, IQ, OQ and PQ of equipment's and autoclaves and filling machines
- Tracking and Intimation to engineering department regarding calibration and PMPs of equipment's
- Daily, monthly and Quarterly calibration of equipment's.
Assistant Manager
Cipla Pvt. Ltd
Goa
01.2018 - 05.2018
- Handled major commercial project in establishing most commercial oncology molecules doxorubicin liposomal injection and paclitaxel Nano particle injection in scale up and exhibit batch completion
- Good exposure in handling scale-up and exhibit batch manufacturing
- Good Hand on experience in handling lipex machine and homogenizers and tangential flow filtration equipment's.
Production Jr. Executive
Pfizer pharmaceutical India Pvt. Ltd.
Vizag
08.2014 - 12.2017
- Handling all component and solution manufacturing activities in sterile injectable formulation
- Participated and worked in 600L and 6000L Propofol commercial line qualifications and commercial batch manufacturing around 200 batches
- Good work experience in DCS (distributed control system) SAP, AMPS, LIMS and electronic BMR and logbooks
- Handling the Pilot Plant projects for scale up, exhibit, PV, commercial batches
- Handling all GDP documentation through SAP transaction
- Ensuring cleaning and sanitization, rotation of disinfectants in clean rooms as per the procedures
- Taking approvals/line clearance from QA department before starting of each activity
- Handling of HOMOGENIZER (Gaulin)
- CGMP Documentation practices, initiation of quality notifications
- Responsible for documentation like log sheets and updating and closing of BMRs
- Compliance to all approved procedure, documents and GMP activities during production.
Executive
Biological E Ltd.
Hyderabad
04.2012 - 08.2014
- Involved in purification and conjugation Process of HIB vaccine and Detoxification and purification of Diphtheria vaccine
- Handling of autoclaves (Machin Fabrik, FEDEGARI), DHS, centrifuges (BECKMAN COULTER)
- Protein Concentration, Diafiltration and Purification (TFF and Depth filters), conjugation and alkaline degradation
- Sterile bulk filtration through 0.22µ filters in grade B area
- Preparation of Lot Summary Protocols and Deviation reports
- Audits face: USFDA, WHO, CDSCO, EU-GMP, ANVISA.
Education
Post Graduation - Biotechnology
Madras University
Graduation - Chemistry
Andhra University
Skills
Good pharmaceutical knowledge
Softwareexposure
Windows, MS Office, SAP (PPIC Module), AMPS, LIMS, TIMS, ERP
Disclaimer
I hereby declare that the information furnished above is true to the best of my knowledge.
Timeline
Senior Technical lead
HCL technologies
04.2024
Assistant Manager
Eugia Pharma specialties UNIT-III (Aurobindo Group)
05.2018 - 04.2024
Assistant Manager
Cipla Pvt. Ltd
01.2018 - 05.2018
Production Jr. Executive
Pfizer pharmaceutical India Pvt. Ltd.
08.2014 - 12.2017
Executive
Biological E Ltd.
04.2012 - 08.2014
Post Graduation - Biotechnology
Madras University
Graduation - Chemistry
Andhra University
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