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DNDi looking for Pharmaceutical Development Manager

 

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DNDi looking for Pharmaceutical Development Manager

The Drugs for Neglected Diseases initiative (DNDi) is an international, not-for-profit research and development (R&D) organization that develops and delivers new treatments for neglected diseases that affect millions of the world’s poorest people. Together with more than 200 public research and industry allies worldwide, we use the power of partnership, innovation, open science, and advocacy to find solutions to a great injustice: the lack of medicines for life-threatening diseases that disproportionately impact poor and marginalized people.

Post : Pharmaceutical Development Manager (South Asia)

Purpose of the position
The Pharmaceutical Development Manager will play a critical role in the delivery of Chemistry, Manufacturing and Control (CMC) activities in India for DNDi and GARDP projects, at all stages of R&D, and to the required quality, budget and timelines. The incumbent will be responsible for managing CMC activities and service providers. This position will contribute to the development and management of pharmaceutical quality systems to assure compliance with GMP and GDP requirements.

Job responsibilities
Manage CMC activities for large scale R&D projects
• Establish strategies and plans that meet project and regulatory requirements
• Act as the Pharmaceutical Development representative on internal and external project teams
• Review and manage technical information and documentation to ensure timely action, compliant storage and efficient retrieval
• Lead regulatory CMC activities (e.g., preparation of IMPD/IND, MAA/NDA) and interactions/scientific with agencies (e.g., CDSCO, EMA, FDA etc.)
• Prepare project updates, presentations and reports for stakeholders (e.g., senior management, SAC, donors)
• Develop and maintain project management skills and technical knowledge to oversee CMC activities effectively
General operational management of CMC service providers
• Identify, evaluate, select and then manage external service providers to monitor progress against milestones, as well as resolve technical, quality or resource issues efficiently
• Develop and maintain suitable project schedules, budgets and risk mitigation plans with project teams and external service providers
• Organise quality agreements and audits for service providers, monitor and improve their GMP and GDP performance, and maintain a qualified service providers list
• Maintain awareness of the contract development and manufacturing environment and relevant service offerings


Development and management of pharmaceutical quality systems
• Contribute to the development and operation of the DNDi Pharmaceutical Quality System to assure compliance with GMP and GDP requirements
• Define best practices and procedures/guidelines for the Pharmaceutical Development department
• Maintain awareness of applicable guidelines and regulations

Additional / specific / project responsibilities
• Actively contributes to strategic initiatives and organizational development of the DNDi South Asia Regional Office
• Exercises high degree of independence to support project delivery
• Supervises permanent staff, contractors and consultants as required
• Deputises for the Pharmaceutical Development Director as required

Reporting line
• The Pharmaceutical Development Manager reports to the Pharmaceutical Development Director, DNDi (Geneva, Switzerland)
• This position has a secondary report to the Director, South Asia Regional Office, DNDi (New Delhi, India)
Resources managed
• Responsible for managing CMC service providers to agreed timelines and financial targets


Interactions
• Works with assigned project teams, consultants, external service providers and collaborators
• Interacts closely with finance, legal, business development and procurement functions
• Builds and establishes credible professional relationships within domain of activities
• This role has a representational role through the promotion of programmes and maintain productive relationships by projecting the image of a credible partner

Candidate Profile
• Strong project management ability (e.g., successful delivery of large projects on time and budget) applied within a multi-disciplinary R&D environment
• Analytical, problem-solving and decision-making competencies
• Effective communication and negotiation skills across different organisational levels, matrices and boundaries
• Ability to work effectively in international collaborations and multicultural environments
• Well organised and structured, able to prioritise and multi-task under pressure to meet deadlines
• Comfortable taking autonomous actions and decisions (up to level of job responsibility)
• Advanced knowledge of CMC, as well as general drug development and regulatory requirements
• Good knowledge of GMP and GDP regulations
• Excellent technical writing skills (reports, regulatory documentation)
• At least six years working in API, formulation or analytical development, regulatory CMC, or CMC management roles
• At least three years working in a similar senior/managerial role in an R&D organisation is preferred
• Experience of working in, or managing, CROs and CDMOs is highly desirable
• Manufacturing, Quality Assurance, or clinical supply experience is desirable
• Bachelor’s degree in relevant discipline (e.g., chemistry, chemical engineering, pharmacy)
• Post-graduate qualification (Masters or Ph.D) in a relevant discipline is preferred
• Fluent in English
• IT-proficient, including spreadsheet and planning software
• Willing and able to undertake national and international business travel (up to 20%)
• Location in India flexible, however expected to attend key internal meetings in person

Additional Information
Experience : 5+
Qualification : B.Pharm, Masters or Ph.D
Location : News Delhi
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Pharmaceutical Development
End Date : 20th February, 2022

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