Job Title: Consultant for Production of Vaccines Pharmaceutical Products & Development of Drug Substances and Drug Products in Nigeria

Location: Abuja
Schedule: Full Time
Contractual Arrangement: External consultant
Contract Duration (Years, Months, Days): 3 months
Organization: AF_NGA Nigeria

Scope of Work

• The scope of Work will entail the delivery of a production line (end to end) and expansion to research and development of drug substances and products in the long term.
• This project will require vast and detailed knowledge of the pharmaceutical production (end-to-end) process that meets NAFDAC, FDA, and EMEA standards.
• The consultancy has two streams which 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.

Scope of Work for the Development Stream includes:

• Conduct situational analysis and 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, and 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, and advise on improvements or modifications that will reflect the commercial realities of the global pharmaceutical space and the ongoing COVID-1 9 pandemic.
• 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.

Scope of Work for the Production Stream includes:

• In collaboration with the development stream, an 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 the situational analysis in 4.2.1. I above, to advise on appropriate and viable pharmaceutical production models for Nigeria in the short and long term. Consideration of 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 an expert opinion on the development of the production facility process and facility designs. This will include:
  • Basis of design
  • Detailed design
• Led construction management to meet NAFDAC and other international regulatory (FDA, EMEA) requirements.  This will include the identification and implementation of the engineering stages which consist of:
  • Release for construction: This will involve the 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 services 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 the development of drug substances and products.
• Advise the Government on the recruitment of the 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 upon with the selected Consultants:

• An inception report detailing a scoping review of existing pharmaceutical capacities and the ecosystem, including a work plan for deliverables.
• The 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 internationally accepted standard tender material for engaging with pharmaceutical engineering houses in the bidding-out concept process.
• Provide expert opinion on the selection of a 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 requirements as may become necessary.
• Support critical sectors like the regulators (NAFDAC) to achieve and sustain relevant maturity levels for regulating the pharmaceutical industry.

Qualifications and Requirements

• 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 of relevant experience delivering capital projects within the international pharmaceutical industry complemented by 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 an 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 of experience in project management in the pharmaceutical sector
• Experience designating and setting up large bioreactors
• Experience setting up a modular pharmaceutical production system.

Competencies

• 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 a 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 specifications.
• Strong analytical, negotiation, oral, and written communication skills.
• Ability to deliver effective presentations, and adapt messages 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 multicultural environment.

Functional Knowledge and Skills:

• In-depth knowledge of international and Nigeria vaccine and pharmaceutical ecosystem
• A 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.

Skills:

• Demonstrated ability to lead a diverse team of professionals in the Pharmaceutical industry
• Proven evidence of participating in the pharmaceutical technology Transfer Process from an existing production line to a newly constructed Production line
• Proven interpersonal skills with the 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.

Languages:

• Written and spoken fluency in English is required. Additional language is an asset.

How to Apply

Interested and qualified candidates should:
Click here to apply online

Application Closing Date

13th November 2022.