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1.0. Scope of work will entail delivery of a production line (end to end) and expand to research and development of drug substances and products in the long term.
1.1. This project will require vast and detailed knowledge of the pharmaceutical production (end to end) process that meet NAFDAC, FDA and EMEA standards.
1.2. The consultancy has two streams that include the development and production workstreams. Both streams will work out of the Project secretariat as a team to collaborate and support themselves to achieve their respective work scope and meet the overall goal of this project.
- 0. Scope of work for the development stream includes
- Conduct situational analysis and a mapping of the pharmaceutical ecosystem including, vaccines, biologicals, diagnostics, etc. to determine in-country capacities. Assess the feasibility of local production of vaccines for human use, drug substances, drug products and explore the potentials of research and development into the use of locally available pharmaceutical substitutes in Nigeria.
- Identify regulatory, policy and bureaucratic barriers to expediting local pharmaceutical production, research and development, and recommend mitigating strategies.
- In collaboration with the production expert, review the business case of local manufacturers under consideration, advise on improvements or modifications that will reflect commercial realities of the global pharmaceutical space and the ongoing COVID-1 9 pandemics.
- Explore and identify potential big pharmaceutical companies willing to support local vaccine production in Nigeria, and the capacities for local researchers to contribute their work to vaccine and drug development.
2.1. Scope Of Work For The Production Stream Includes
- In collaboration with the development stream, expert is to develop a business case for developing pharmaceutical capacities in Nigeria, in addition to a clear road map and strategy for Nigeria to become an African hub for pharmaceutical production and development.
- In collaboration with the development stream, use the outcome of situational analysis in 4.2.1.i above, to advise on appropriate and viable pharmaceutical production model for Nigeria in the short and long term. Consideration to approaches such as modular, full production line with fill/finish, or basic fill-finish as stand alone, will be given. This will mean collaborations with existing manufacturers in the space to enable the fill/finish to have a feed into that leg of production.
- Lead and give expert opinion on the development of the production facility process and facility designs. This will include:
- Basis of design
- Detailed design
- Lead construction management to meet NAFDAC and other international regulatory (FDA, EMEA) requirements. This will include identification and implementation of the engineering stages which consist of:
- Release for construction: This will involve recruitment of Civil engineers, Construction engineers, Project engineers, Quality engineers, Regulatory institutions, Purchasing/Cost controllers, Schedulers, and other subject area experts required for the process.
- Release for commissioning and validation: This would involve Commissioning Engineers, validation and Quality Engineers.
- Release for manufacturing: Certifying the facility is fit and ready to produce the desired molecule (vaccine, drug substance, or drug product) by NAFDAC (Note: FDA and EMEA approvals will be sought if products are intended for either the American or European market respectively).
- Render service as a pharmaceutical expert advisor to both Government and private sector players to accelerate and enable the establishment of a production line for vaccines and other pharmaceutical products in Nigeria, and expansion to development of drug substances and products.
- Advice Government on the recruitment of appropriate mix of experts required for vaccine production and further work on research and development.
Expected Deliverables (Exact Durations And Proportion Of Payment Linked To Deliverables Will Be Determined And Agreed With The Selected Consultants)
- An inception report detailing scoping review of existing pharmaceutical capacities and the ecosystem, including a workplan for deliverables.
- Business case for the viability of the local manufacture of vaccines, drug substances and drug products in Nigeria and the opportunities for expansion into research and development of local molecules, substances, and drug products.
- A project implementation Strategy and roadmap from concept to market. iv. Develop on internationally accepted standard tender material for engaging with pharmaceutical engineering houses in the bidding out concept process.
- Provide expert opinion on selection of qualified engineering house for the project.
- Technical support for the recruitment and constitution of a client-side team to mirror and interphase with engineering houses throughout the project cycle.
- Human-resource needs assessment and training plan for the production
- Support technology transfer requirement as may become necessary.
- Support critical sectors like the regulators (NAFDAC) to achieve and sustain relevant maturity levels for regulating the pharmaceutical industry.
4.0. Competencies And Technical Background And Experience
- 15+ years ' experience delivering capital projects within the international pharmaceutical industry.
- Previous history and capacity to handle capital investment projects in the pharmaceutical sector worth over 300million USD.
- Proven track record of assembling diverse teams of local and international experts to constitute client-side team.
- Proven history of past engagement with global industry experts in the delivery of capital pharmaceutical projects in a timely manner and to project specification.
- Strong analytical, negotiation, oral and written communication skills.
- Ability to deliver effective presentations, adapt message and visual aids for multiple audiences.
- Effective facilitation skills with proven ability to engage and train a group of individuals at international, national and sub-national levels.
- Ability to work in a multi-cultural environment
5.0 Functional Knowledge And Skills
- In-depth knowledge of international and Nigeria vaccine and pharmaceutical ecosystem
- Clear understanding of the FDA, NAFDAC and EMEA regulatory protocols
- In-depth knowledge of commercial and manufacturing bridge
- In depth knowledge of a functional pharmaceutical setup, for both upstream and downstream
- In-depth knowledge of the development of the production facility process and facility designs.
6.0 Education Qualifications
A degree in Pharmacy, Medicine, Chemistry, chemical engineering or related sciences, with an advanced qualification in the same or in pharmaceutical technology, chemical engineering or environmental system design.
Post graduate training or specialization in Pharmaceutics, Good Pharmaceutical Practices (GXP), Good Manufacturing Practice, and advanced project management certificate
5 years' relevant experience delivering capital projects within the international pharmaceutical industry complemented with experience in
- Capital (construction) pharmaceutical projects of $300million,
- Experience developing a business and investment case for large capital pharmaceutical projects over $300 million
- Experience managing Engineering house and representing a client in the construction of a pharmaceutical end to end production line
- History of participating and representing clients (with pharmaceutical houses) in the construction of a pharmaceutical fill and finish line.
- At least 15 years’ experience in project management in the pharmaceutical sector
- Experience designating and setting up large bioreactors
- Experience setting up a modular pharmaceutical production system
- Demonstrated ability to lead a diverse team of professionals in the Pharmaceutical industry
- Proven evidence of participating in pharmaceutical technology Transfer Process from an existing production line to a newly constructed Production line
- Proven interpersonal skills with ability to promote consensus, communicate progress and results, and resolve issues in a proactive manner, while ensuring effective work practices and ethics: diplomacy, tact, and courtesy.
7.1. Written and spoken fluency in English is required. Additional language is an asset.