VIJAYA BHASKAR RATNAKARAM
Pune
Summary
Knowledgeable professional with several years of experience bringing planning and problem-solving abilities.
I have good knowledge on process development, technology transfer and supporting to manufacturing. Hands on establishment of manufacturing facility, qualification and validation of the commercial scale batches.
Overview
22
22
years of professional experience
Work History
Senior Production Manager
Serum Institute of India Pvt. Ltd.
Pune
11.2011 - Current
- Lead team by applying dynamic leadership talent to obtain excellent performance in accordance with project goals.
- Ensured smooth running of production operations by developing and implementing effective strategies.
- Monitored and evaluated performance of staff, identified areas for improvement and took corrective action when necessary.
- Managed the budgeting process to ensure efficient use of resources while maintaining quality standards.
- Developed and maintained relationships with external suppliers to ensure timely delivery of materials and services.
- Organized regular meetings with team members to discuss progress, identify problems and devise solutions.
- Implemented safety procedures in all areas of the production facility to protect personnel from hazards.
- Reviewed customer feedback on products and services to identify opportunities for improvement.
- Coordinated with multiple departments such as sales, marketing, finance to ensure successful execution of projects.
- Maintained updated records of inventory levels, orders received, deliveries made for accurate tracking purposes.
- Identified cost-saving measures through resource utilization optimization techniques or process improvements initiatives.
- Collaborated with engineering teams to design processes that meet quality requirements while minimizing costs and timeframes.
- Assisted in hiring qualified personnel including interviewing potential employees and providing training programs for them.
- Provided technical advice regarding equipment specifications or usage issues as needed for optimal operation efficiency.
- Conducted periodic reviews of existing processes and procedures to detect any discrepancies or noncompliance issues.
- Ensured adherence to company policies and regulations related to safety, environment protection and legal compliance matters.
- Negotiated contracts with vendors and suppliers for securing best terms and prices on raw materials or other goods and services.
- Collaborated with leadership to develop production department budget and forecast.
- Coached and mentored employees to develop and enhance career skills.
- Aided raw material planning and escalated supplier issues, preventing shortages.
- Created SOPs and documented system, planning criteria and procedures.
- Scheduled staff work assignments, rotations and overtime.
- Cultivated communication among senior managers and floor supervisors to encourage optimal productivity.
- Promoted employee safety awareness based on understanding of regulatory mandates and organizational best practices.
- Developed and implemented significant process improvements to enhance department quality and throughput.
- Presented capital equipment justification for machine and technology upgrades.
- Maintained top-notch quality control standards and eliminated downtime to maximize revenue.
- Supported audit reviews and initiated corrective actions.
- Eliminated process discrepancies, implementing continuous improvements for scheduling procedures.
- Partnered with human resources on training compliance and performance progression methodologies.
- Delegated tasks to multiple employees while maintaining efficient workplace.
- Observed and monitored utilization of equipment.
- Assigned tasks to employees and monitored productivity, performance and task completion.
Deputy Manager
Biological E. Ltd.
Hyderabad
03.2007 - 11.2011
- Planning and execution of new process development activities related to bacterial Polysaccharide conjugate vaccines
- Planning and execution of Scale up studies and technology transfer to production
- Preparation of Protocols, batch manufacturing Record, Instrument SOPs and technology transfer notes
- Coordinating and interdepartmental activates related to manufacturing sciences and production
- Leading the team for giving qualified products
- Being a responsible team lead to solve the production trouble shoots on priority
- Planning work schedule and working as per the time lines
- Reporting and discussing with Superior about the project progress and implementations
- Projects Handled: Haemophilus influenzae type-b Polysaccharide Conjugation vaccine process adoption and development
- Haemophilus influenzae type-b Polysaccharide Conjugation vaccine process Technology transfer and Scale up to production scale
- Purification of HIB polysaccharide (PRP) with different purification methods for making good stable polysaccharide meeting the WHO compiles
- Removal of endotoxin from Hib crude PRP at production scale
- Identification and route cause for black particles in Diphtheria toxoid bulks
- Alternate Polysaccharide/oligosaccharide conjugate methods development and conjugate stability
- Meninge Polysaccharide Vaccine Development at R&D level Progress
Sr.Research Associate
Shantha Biotechnics Ltd.
Hyderabad
10.2003 - 03.2007
- Planning and execution of new process development activities related to bacterial Polysaccharide conjugate vaccines
- Recombinant Protein expression studies in Yeast and Bacteria and process optimization
- Scale up studies and transferring technology from R&D to production
- Preparation of Protocols, batch manufacturing Record, Instrument SOPs and technology transfer notes
- Working Under cGLP and cGMP facility
- Projects handled: Antigen purification and potency improvement of HBsAg at R&D scale
- Yields improvement of HBsAg and potency at R&D level
- Polysaccharide Conjugation vaccines Development and Technology transfer and Scale up studies
- HPV Fermenter medium optimization and Expression studies in both bacterial and yeast expression systems
Asst.Professor
Madanapalli Institute of Technology and Science
Madanapalli
06.2002 - 10.2003
- Taking classes for B.Tech Biotechnology and conducting Lab Experiments
- Handling of labs for B.Tech Biotechnology four years students
- Projects Handled: Expression and characterization of α-amylase from Bacillus Subtilis and Aspergillus niger
- Medium optimization and expression level studies on alcohol production in Saccharomyces Servicea
- Extraction and yield studies on lipids and oils in Saccharomyces Servicea
Education
M.Sc - Biochemistry
Sri Venkateswara University
Tirupati04.2002
B.Sc - Biochemistry
Srikrishnadevaraya University
Ananthapur04.2000
Skills
- Upstream
- Downstream Processing
- Extraction and purification
- Polysaccharide Conjugation
- Strategic Planning
- Talent Development
- Budget Oversight
- Partnership Development
- Resource Allocation
- Cross-Functional Collaboration
- Troubleshooting and problem resolution
- Reporting management
- Operations Management
- Organizational improvement
- Corporate Communications
- Cross-Functional Communication
- Risk Management
- Budget Preparation
- Audit management
- Team Management
- Corrective Actions
- Regulatory Dossiers
- Process Validation
- Internal Auditing
- Audit Compliance
- Documentation Management
- Change Control Procedures
- Deviation Management
- OOS/OOT Quality Management
- CAPA Management
- SOP Development
Accomplishments
- State Special jury award at State Level Science Fair
- Three times district First prize at District Level Science Fair
- Advisory committee member in NSS during Bachelor Degree
- Gold medal as Spot Painter from S.K.University
Languages
- English
- Hindi
- Telugu
Personal Information
- Date of Birth: 05/15/80
- Nationality: Indian
- Marital Status: Married
Timeline
Senior Production Manager
Serum Institute of India Pvt. Ltd.
11.2011 - Current
Deputy Manager
Biological E. Ltd.
03.2007 - 11.2011
Sr.Research Associate
Shantha Biotechnics Ltd.
10.2003 - 03.2007
Asst.Professor
Madanapalli Institute of Technology and Science
06.2002 - 10.2003
M.Sc - Biochemistry
Sri Venkateswara University
B.Sc - Biochemistry
Srikrishnadevaraya University
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