DESCRIPTION

The Technical Project Leader acts as the main CMC responsible for all the activities related to the development and submission of invoX BE’s drug / device combination medical products complying with all the appropriate regulatory standards.

The objectives of this role are:

• To manage all the activities pertaining the invoX BE’s drug /device programmes to deliver the project objectives.
• To manage external suppliers (CRO/CDMO) and secure that the project flows according to the agreed timelines and budget and to ensure that customer requirements are met, including FDA and EMA regulatory requirements whilst delivering invoX’s business goals and objectives.
• To take overall responsibility for the CMC coordination of all the activities in terms of the development, GMP production and release of Soft Mist Inhalation formulations and final drug products.

The Project Technical Leader should require little direction or supervision from the Leadership Team and should be capable of driving forward the program across the multiple phases of the projects.

SKILLS, KNOWLEDGE AND EXPERTISE

Experience/Skills Essential

• Solid experience at as a CMC project coordinator/Project Technical Leader in a drug development, medical device or industrialisation role within the Pharma Industry
• Substantial experience in technical management of pharmaceutical drug development programmes including formulation and clinical trials to regulatory approval, and close partnership with major functions within the industry (commercial, R&D, IP, legal, finance)
• Experience in working to ISO13485 and 21 CFR Part 820
• Experience in working under ICH Q8,ICH Q9 and ICH Q10 principles
• Experience in working under QbD principles
• Excellent written and verbal communication skills
• Exemplary planning skills

Strong analytical and problem-solving skills

• Strong IT user skills
• Ability to undertake risk analysis and of risk management
• Substantial experience of dealing with suppliers and customers at a technical level.
• Superior presentation skills

QUALIFICATIONS

• Degree qualification in a science or technology subject

KEY RESPONSIBILITIES

• Take the CMC technical leadership of inhaled drug development programs (from early phase up to submission) at approved CRO/CDMO partners and also internally.
• Develop experimental programs and work plans and schedule to meet performance objectives.
• Identify complex problems and offer effective solutions through development or modification of test methodology.
• Review test results in alignment with the project goals, identify causes of variances and recommend solutions to achieve goals.
  · Prioritize assignments to meet project objectives and deadline. · Adhere to federal, state, and local health, safety and environmental regulations.

· Execute duties in accordance with invoX Pharma NV SOPs. · Act as primary scientific contact to external collaborators (CROs/CDMOs).

• Prepare regulatory documentation to support interactions with regulatory authorities.
• Supervise external suppliers in order to assure that these comply with objectives and with timelines.
• Review and approve non-GMP and also GMP documentation (methods, reports, protocols, manufacturing documents, specifications and other relevant documents).
• Prepare Requests for Proposals (RfP) and define the work package for all relevant activities of work.
• Select and approve suppliers for the different phases of the program (includes RM suppliers and also CROs/CDMOs).
• Support audits, as a technical co-auditor.
• Actively participate in pre-clinical and clinical trials as observer and facilitator of activities.

The objectives of this role are:

• To manage all the activities pertaining the invoX BE’s drug /device programmes to deliver the project objectives.
• To manage external suppliers (CRO/CDMO) and secure that the project flows according to the agreed timelines and budget and to ensure that customer requirements are met, including FDA and EMA regulatory requirements whilst delivering invoX’s business goals and objectives.
• To take overall responsibility for the CMC coordination of all the activities in terms of the development, GMP production and release of Soft Mist Inhalation formulations and final drug products