Pharmaceutical Development Manager

Pharmaceutical Development Manager

Location: South Asia Regional Office (New Delhi, India)

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. Driven by collaboration, not competition, and by patients’ needs, not profits, we promote equitable access, foster inclusive and sustainable solutions, and advocate for a more effective global biomedical R&D system that meets the needs of neglected patients.

Since our inception, DNDi has delivered thirteen new treatments for people with sleeping sickness, visceral leishmaniasis, Chagas disease, HIV, hepatitis C, and malaria that have saved millions of lives. We aim to deliver more new treatments – addressing R&D gaps for neglected tropical diseases and viral infections, including new pandemic-prone diseases (such as COVID19) and climate-sensitive diseases (such as Dengue) with a focus on the needs of patients in low- and middle-income countries.

With over 200 employees across the world, DNDi is committed to diversity, equity, and inclusion as essential parts of our culture and key drivers of our success. We encourage candidates of diverse profiles and backgrounds to apply.

DNDi SOUTH-ASIA
DNDi South-Asia was established in 2004. An integral part of DNDi’s global network, it mobilizes and supports Indian research and science institutions to develop an end-to-end approach to neglected diseases R&D. DNDi aims to co-create sustainable solutions with Indian partners while sharing expertise with the Indian biotechnology industry and ensuring access for patients and public health. It supports the implementation of R&D projects on visceral leishmaniasis, hepatitis C, filariasis, pediatric HIV, Dengue, and antimicrobial resistance.

PHARMACEUTICAL DEVELOPMENT
As a strategic transversal R&D function, the Pharmaceutical Development department advances the design, development, and industrialisation of new treatments by leveraging an external network of partners with diverse product development, drug delivery and manufacturing capabilities. Its team members lead pharmaceutical development, regulatory CMC, manufacturing, and supply activities across our portfolio, as well as building external partner capabilities, and introducing new projects and technologies.

The Pharmaceutical Development Team also supports projects for the Global Antibiotic Research and Development Partnership (GARDP).

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.

Specific 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
aintain 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:
Exercises high degree of independence to support project delivery
Supervises permanent staff, contractors and consultants as required
Deputises for the Senior Pharmaceutical Development Manager as required

Reporting line
The Pharmaceutical Development Manager reports to the Senior Pharmaceutical Development Manager, 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 programs and maintain productive relationships by projecting the image of a credible partner

Job Requirements

Skills and Attributes
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)

R&D Technical Skills
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)

Experience
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
Formulation development, manufacturing, Quality Assurance, or clinical supply experience is desirable


Education
Bachelor's degree in relevant discipline (e.g., chemistry, chemical engineering, pharmacy)
aost-graduate qualification (Masters or Ph.D) in a relevant discipline is preferred

Other Requirements
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

Other information
Status: Full time - Employee

To apply
Please submit your application using the online form
Deadline for application: accepting applications until 2nd February 2025
Only shortlisted candidates will be contacted
Application submission for this position may close early if we have enough suitable applicants