Technical Specialist – Technical Support (Pharmaceutical Manufacturing / Biologics)
Location: Mumbai (Andheri), India
Work Mode: Hybrid
Department: Technical Operations / Manufacturing Support
Job Overview
We are seeking a highly experienced Technical Specialist – Technical Support to provide advanced technical expertise across sterile, biological, and biosimilar pharmaceutical manufacturing operations. This role focuses on ensuring reliable product supply through technical troubleshooting, manufacturing support, process optimization, and lifecycle management of complex biologic products.
The position requires strong expertise in GMP manufacturing, biologics/biosimilars, tech transfer, regulatory compliance, and end-to-end product lifecycle management, along with the ability to lead cross-functional technical decision-making and support global manufacturing operations.
Key Responsibilities
Technical Expertise & Manufacturing Support
Provide subject matter expertise in sterile, biological, and biosimilar manufacturing processes.
Support contract manufacturers with technical guidance to ensure consistent and reliable product supply.
Troubleshoot complex manufacturing and production issues across GxP environments.
Serve as technical point of contact for cross-functional stakeholders.
Tech Transfer & Process Improvement
Lead and support site transfers, process improvements, reformulations, and material source changes.
Oversee validation activities related to manufacturing and packaging processes.
Identify process gaps and implement improvements to enhance efficiency and compliance.
Apply data-driven insights (KPIs) to optimize manufacturing performance.
Regulatory & Documentation Support
Author, review, and approve technical and regulatory documentation, including:
Technical justifications
Regulatory response documents (RFI responses)
Technical summary reports
eCTD Module 3 documentation
Quality Overall Summaries
Ensure compliance with global regulatory and GMP requirements.
Provide technical input for licensing and manufacturing compliance activities.
Project Leadership & Lifecycle Management
Manage complex lifecycle projects including product changes, site transfers, and process upgrades.
Conduct technical due diligence for new products, acquisitions, and manufacturing modifications.
Lead risk assessments and ensure robust mitigation strategies.
Coordinate cross-functional project execution and ensure timely delivery of milestones.
Manufacturing Decision Support
Support batch release decisions and product disposition discussions.
Participate in cross-functional governance meetings for manufacturing decisions.
Evaluate batch performance data and recommend corrective actions.
Contribute to product write-off and deviation resolution decisions.
Stakeholder Collaboration & Communication
Act as SME during audits, inspections, and regulatory discussions.
Communicate technical findings to internal and external stakeholders.
Collaborate with manufacturing, quality, regulatory, and supply chain teams.
Provide clear, structured communication of complex technical concepts.
Continuous Improvement & Innovation
Drive continuous improvement initiatives across manufacturing and technical operations.
Identify opportunities for process optimization and cost efficiency.
Lead implementation of data-driven manufacturing enhancements.
Support development of new tools, methodologies, and best practices.
Budget & Resource Management
Support budgeting and cost-benefit analysis for technical projects.
Assist in forecasting and managing project-related financial planning.
Ensure efficient resource utilization across assigned initiatives.
Training & Mentorship
Mentor internal and external teams on technical and manufacturing best practices.
Provide training support for technical and GMP-related processes.
Promote knowledge sharing and capability development within teams.
Required Qualifications
Education
Bachelor’s or Master’s degree in Pharmacy, Biotechnology, Chemical Engineering, Life Sciences, or related technical discipline
Certifications (Preferred)
PRINCE2 Certification (preferred)
MS Project proficiency (preferred)
Experience Required
Fresher Eligible: No
Required Experience: Minimum 8–12+ years of experience in pharmaceutical technical operations
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