SHASHANT SHARMA
Production Manager Sterile Injectables
Bhopal,Madhya Pradesh
Summary
Accomplished professional in Sterile Injectables and Biologics Manufacturing with over 17 years of expertise in Fill-Finish Operations, Lyophilization, and Aseptic Processing. Strong command of cGMP, QMS, Data Integrity, and Regulatory Compliance with a proven ability to navigate complex frameworks set by USFDA, EMA, PMDA, and MHRA. Demonstrated success in Production Planning, Batch Execution, and Changeover Optimization has consistently driven operational efficiency and enhanced productivity. Recognized for securing multiple USFDA approvals while achieving exceptional quality acceptance rates in highly regulated environments. Smoothly direct employees carrying out [Production] operations to achieve demanding production goals, schedules and budget targets. Driven leader with excellent analytical, decision-making and project management abilities. Maintain employee focus and achieve quality targets with hands-on supervision.
Overview
18
18
years of professional experience
4
4
Certifications
Work History
Production Manager
Eris Bionxt Pvt. Ltd.
Bhopal
09.2025 - 11.2025
- Oversee biosimilar manufacturing operations ensuring cGMP compliance and validated process performance.
- Lead Area/Equipment Qualification (URS, FAT, SAT, DQ, IQ, OQ, PQ) for developmental and commercial batches.
- Drive production planning, delivering 98%+ on-time output and improving workforce efficiency by 20%.
- Monitor process parameters (CQAs, CMAs, CPPs) using data-driven controls to ensure robust operations.
- Resolved issues quickly to maintain productivity goals.
- Managed internal operational standards and productivity targets.
- Standardized production procedures, job roles, and quality assurance guidelines.
- Increased overall productivity by identifying bottlenecks in the production process and proposing effective solutions.
- Managed continuous improvement initiatives to drive gains in quality, flow, and output.
- Conducted root cause analysis on production issues, devising corrective actions to prevent recurrence.
Associate Manager Production
Biocon Biologics India Ltd.
Bommasandra
01.2018 - 08.2025
- Led end-to-end manufacturing operations across high-speed vial and cartridge fill-finish lines.
- Secured 3 USFDA approvals for biosimilars (mAbs and Insulin) via effective scale-up and optimization.
- Reduced drug product rejection rate by 2% and optimized changeover times by 15%.
- Directed aseptic manufacturing of Insulin and Oncology products ensuring 90% OEE.
- Championed inspection readiness for new GLP1 and oncology analogue filings for US and EU markets.
- Initiated process improvements based on thorough analysis of internal operations data resulting in enhanced productivity levels.
- Managed cross-functional projects, ensuring timely completion and alignment with company objectives.
- Led team meetings regularly to discuss progress updates, identify challenges or roadblocks, and provide guidance towards successful project completion.
- Collaborated closely with senior management on strategic planning efforts, aligning departmental goals with overarching company objectives.
- Enhanced team productivity by implementing efficient project management strategies.
- Mentored junior team members, contributing to their professional growth and skill development.
- Successfully managed multiple high-priority tasks simultaneously while maintaining strict deadlines ensuring optimal resource allocation.
- Optimized workflow processes to reduce bottlenecks and increase overall effectiveness.
- Established strong relationships with key stakeholders, fostering collaboration and mutual support.
- Streamlined processes for increased efficiency and cost savings within the department.
- Proactively identified areas for improvement, implementing solutions that led to significant cost savings.
- Oversaw training and onboarding process for all newly hired employees within production Department.
- Conducted regular performance evaluations of staff members, providing constructive feedback and identifying areas for growth.
- Leveraged industry best practices to enhance operational efficiency within the organization.
- Improved client satisfaction by consistently delivering high-quality work on schedule.
- Delivered comprehensive reports on key performance indicators, driving data-driven decision-making among leadership teams.
- Remedied issues and conflicts among workers using negotiation and active listening.
- Championed employee engagement initiatives, boosting morale and promoting a positive workplace culture.
- Mentored and supported 100+ production department employees to create strong workplace culture.
- Supervised day-to-day operations to meet performance, quality and service expectations.
- Completed regular inventory counts to verify stock levels, address discrepancies, and forecast future needs.
- Established team priorities, maintained schedules and monitored performance.
- Defined clear targets and objectives and communicated to other team members.
- Recruited, interviewed and hired employees and implemented mentoring program to promote positive feedback and engagement.
- Streamlined and monitored quality programs to alleviate overdue compliance activities.
- Assisted in organizing and overseeing assignments to drive operational excellence.
- Trained personnel in equipment maintenance and enforced participation in exercises focused on developing key skills.
- Evaluated employee performance and conveyed constructive feedback to improve skills.
- Successfully managed budgets and allocated resources to maximize productivity and profitability.
- Controlled resources and assets for department activities to comply with industry standards and government regulations.
- Established performance goals for employees and provided feedback on methods for reaching those milestones.
Assistant Manager
Aurobindo Pharmaceutical Ltd. Unit-IV
Hyderabad
06.2017 - 12.2017
- Supervised sterile production lines for ophthalmic, bag, and BFS (Blow-Fill-Seal) operations.
- Executed micro-scheduling and manpower optimization to enhance throughput.
- Managed SAP entries, raw material indents, and production reporting.
- Developed strong working relationships with staff, fostering a positive work environment.
- Collaborated with the management team to develop strategic plans for business growth and improvement.
- Completed regular inventory counts to verify stock levels, address discrepancies, and forecast future needs.
- Coordinated with vendors to ensure timely delivery of products and resolve any supply chain issues.
Senior Executive
Hospira Healthcare India Pvt. Ltd. (Pfizer Inc.)
Vishakhapatnam
12.2013 - 06.2017
- Managed Area and Equipment Qualification (URS/DQ/IQ/OQ/PQ/ILQ) for sterile injectables.
- Handled production operations and QMS activities including Change Control, Deviations, and CAPA.
- Assisted with day-to-day operations, working efficiently and productively with all team members.
- Used critical thinking to break down problems, evaluate solutions, and make decisions.
- Awarded Performance Certification for line qualification and commercialization (2016).
Production Officer
Zydus Cadila Healthcare
Goa
02.2011 - 08.2013
- Supervised washing, sterilization, depyrogenation tunnels, and autoclave cycles.
- Maintained online BMR documentation and logbook accuracy ensuring 100% data integrity.
- Resolved issues quickly to maintain productivity goals.
- Coordinated with other departments to maintain smooth and efficient product flow.
- Improved product quality by monitoring production processes, conducting inspections, and initiating corrective actions as needed.
- Optimized workflow through effective resource allocation and scheduling adjustments.
- Created an inclusive work culture that encouraged collaboration and open communication among staff members at all levels within the organization.
- Maintained accurate documentation of production data, enabling informed decision-making for process improvements.
- Enhanced production efficiency by implementing lean manufacturing techniques and reducing waste.
Production Officer
MJ Biopharma
Navimumbai
08.2009 - 02.2011
- Performed insulin batch formulation, filtration, and aseptic filling.
- Led equipment validation/requalification and resolved technical breakdowns.
- Managed team of 15 production associates, overseeing productive production processes and meeting all deadlines.
Production Officer
Samrudh Pharmaceutical Pvt. Ltd.
Boisar
04.2008 - 07.2009
- Led sterile production operations from material dispensing to aseptic filling and sterilization.
- Managed team of 10 production associates, overseeing productive production processes and meeting all deadlines.
Education
MBA - Pharma Management
ICFAI Tripura University (DE)
Bangalore2020
B. Pharma -
VNS Institute of Pharmacy (R.G.P.V)
Bhopal2007
Skills
Operations: Sterile/Aseptic Production, Lyophilization, Fill-Finish (Vials, Cartridges, PFS, Ampoules, FFS & BFS), Isolator & Packing Operations
Compliance: cGMP, GxP, QMS, Data Integrity, Audit Readiness & Management (USFDA, EMA, ANVISA, TGA)
Technical: Process Validation (URS/IQ/OQ/PQ/ILQ), MSAT, Tech Transfer, Risk Analysis (FMEA & HAZOP), SOP & BMR Preparation
Management: Project Management (Greenfield/Brownfield), CMO/CDMO Management, Supply Chain Optimization, Budget & Cost Optimization
Digital Tools: ERP, SAP, e-BMR, Trackwise, DMS, e-VLMS
Strategic: Budget & Cost Optimization, Global Supply Chain, Capacity Planning, Change Management
Accomplishments
- USFDA Approvals: Secured 3 USFDA approvals for biosimilar commercial batches (mAbs & Insulin analogs) by managing scale-up and exhibit batch manufacturing.
- Audit Success: Successfully supported multiple regulatory audits (US, PMDA, EMA) with zero major observations.
- Operational Excellence: Achieved 98.2% quality acceptance rate and 90% OEE in critical aseptic manufacturing lines.
- Efficiency: Reduced drug product rejection rates by 2% and changeover times by 15% at Biocon Biologics.
Certification
Lean Six Sigma Green Belt (Biocon Biologics, 2024)
Timeline
Production Manager
Eris Bionxt Pvt. Ltd.
09.2025 - 11.2025
Associate Manager Production
Biocon Biologics India Ltd.
01.2018 - 08.2025
Assistant Manager
Aurobindo Pharmaceutical Ltd. Unit-IV
06.2017 - 12.2017
Senior Executive
Hospira Healthcare India Pvt. Ltd. (Pfizer Inc.)
12.2013 - 06.2017
Production Officer
Zydus Cadila Healthcare
02.2011 - 08.2013
Production Officer
MJ Biopharma
08.2009 - 02.2011
Production Officer
Samrudh Pharmaceutical Pvt. Ltd.
04.2008 - 07.2009
MBA - Pharma Management
ICFAI Tripura University (DE)
B. Pharma -
VNS Institute of Pharmacy (R.G.P.V)