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
Inventory management
Knowledge on QMS tools
Good exposure on GMP and GDP
Compounding and manufacturing
Process optimization and development
Equipment’s and area qualification
Manpower management and cost analyses
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