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. 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.

The R&D organisation drive therapeutic innovation from the lab bench to the patient bedside. it develops DNDi's portfolio of drug candidates from the onset (with the design of target product profiles) to the end point (enabling patients' access to the new treatments). With members located in various DNDi offices worldwide, R&D teams are key enablers of DNDi's virtual research model which relies on collaborative partnerships with industry and science partners worldwide, fully inclusive of LMICS clinicians and researchers. Projects are run by project leaders and team members regrouping needed expertise from all DNDI functions, beyond R&D.

The R&D organisation include three clusters of Diseases expert teams: NTD/Mycetoma and Leishmaniasis, NTD/Chagas-Filarial-HAT and Viral Diseases. Medical Affairs (Pharmacovigilance, Clinical Quality and Assurance, Regulatory and Translational Sciences), Global Clinical Operations, Discovery and Pharmaceutical Development teams complement the R&D expertise. Projects review, Science and strategy is managed by the Scientific Internal Review Committee (SIRC); The R&D Coordination team lead the R&D organisation for all other topics.

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 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 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 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 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 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 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 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

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