Manager, Co-Development

Job Summary

This position is responsible for leading the Codevelopment products development, process development, timely submissions and contribute for timely product approvals.  This role oversees the Launch batches 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 technical development, project management, submissions, commercial operations, cross-functional collaboration within Apotex, and third party products. Demonstrate effective team leadership to drive high-quality, efficient product development, time management of third party products aligned with organizational objectives.

Job Responsibilities

Key Responsibilities:

• Contributes to formulate development of strategies relating to formulation/product/process development, risk assessment, product technology transfers, and scale ups, as well as troubleshooting.
• Plan and oversee product development and project management activities for injectables, Inhalers, semisolids, Biosimilars and ophthalmic products.
• Extend support to Launch 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 development and Life cycle management.
• 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 Co-Development 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:

• Actively engage with Co-Development partners for finalisation of development strategies, projects progress monitoring, help to remove technical challenges and  contributes for timely execution of allotted projects.
• Engage for the NPD Launch Support, Lead PLCM,  activities for new product introductions, site transfers, commercial launches, life cycle management with third party colloborations
• Champion for the all 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 development 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.
• Mentor and develop team capabilities, foster a high-performance culture, and support talent acquisition and onboarding.
• 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 (M.Pharm/ Ph.D.preferred).
• Proven experience in formulation development of sterile dosage forms, semisolids, complex injectables, inhalers, combination products and device handling experience.
• Strong understanding of global regulatory requirements and Project Delivery experience (e.g., USFDA, Canada, TGA, EMA).
• Demonstrated leadership in managing teams and cross-functional projects.
• Excellent communication, problem-solving, and organizational skills.
• Knowledge on preparation of various documents like SOPs, formats, protocols, reports etc

Experience:

• Minimum 15 to 20 years of progressive experience in Injectable, liquid, complex  and Ophthalmic formulation development and  life cycle managements.
• About 10 years of manufacturing experience of submission, and commercial batches at CMO
• Demonstrated leadership and team management experience for the role