Deputy Manager - Manufacturing, Science and Technology

Job Summary

This position is responsible for leading the Manufacturing and Product Life Cycle Management of injectables, Semi solids , inhalaers, biosimilars and ophthalmic drug products, ensuring all activities comply with global quality and regulatory standards. The role involves strategic planning, extend support for execution of commercial operations, cross-functional collaboration within Apotex, and third party products. Demonstrate effective team leadership to drive high-quality, efficient life cycle management of third party products aligned with organizational objectives.

Job Responsibilities

• Plan and oversee product life cycle management activities for injectables, Inhalers, semisolids, Biosimilars and ophthalmic products.
• Extend support to commercial planning, project management team for the strategic initiatives.
• Act as SPOC for ensuring the technical adequacy for SDC, Scale ups, Line transfers, Validations during product Life cycle management
• Involve in nitrosamine risk assessment and other associated technical reviews.
• Ensure compliance with global regulatory standards and local guidelines requirements.
• Lead strategic initiatives to optimize commercial operations, resource utilization, and department SOPs.
• Collaborate with cross-functional teams across the site to support for seamless MS&T processes.
• Drive continuous improvement and operational safety initiatives to enhance productivity and compliance.
• Engage with internal stakeholders and external partners to meet the goals of Apotex Research Pvt. Ltd.

Job Responsibilities:

• Technical Transfer and Launch Support- Lead MS&T activities for new product introductions, site transfers, commercial launches, life cycle management with third party colloborations
• Champion for the all BMR technical documentations, data review , draft reports review, change proposal evaluation and offer decisions.
• Lead commercial tech transfer for injectable and ophthalmic products, ensuring QbD-based, regulatory-compliant processes.
• Oversee end-to-end product transfer, including both technical and analytical gap assessments, equipment and line capabilities, Scale up batches, validation, and support the narratives for regulatory submissions.
• Manage third party operations from technical perspectives viz., equipment readiness, and resource planning to support timely project execution.
• Collaborate cross-functionally both with internal teams and external partners to drive seamless business execution and technology transfer.
• Ensure robust documentation, compliance, and continuous improvement in quality and safety practices.
• Provide strategic updates to leadership and contribute to organizational goals through flexible, value-driven leadership.
• Identify the site transfer or validation risks and plan for risk mitigation controls in alignment with CFT.

Job Requirements

Education, Knowledge, Skills and Abilities:

• Advanced degree in Pharmaceutical Sciences or related field (Ph.D./M.Pharm preferred).
• Proven experience in formulation development of sterile dosage forms, semisolids, complex injectables, inhalers and device handling experience.
• Strong understanding of global regulatory requirements and Project Delivery experience (e.g., USFDA, Canada, TGA, EMA).
• Excellent communication, problem-solving, and organizational skills.
• Knowledge on preparation of various documents like SOPs, formats, protocols, reports etc

Experience:

• Minimum 11 to 14 years of progressive experience in Injectable, liquid, complex and Ophthalmic formulation development or life cycle managements.
• About 6 to 8 years of manufacturing experience of submission, and commercial batches at CMO