Negotiable
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CMC Technical Project Leader
role at
invoX
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 applicable regulatory standards.
Department:
CMC
Location:
invoX Belgium N.V. - Remote
OverviewThe Technical Project Leader acts as the main CMC coordinator for development and submission activities of invoX BE’s drug / device combination products, ensuring compliance with regulatory standards. The objectives of this role are:
Manage all activities pertaining to invoX BE’s drug / device programmes to deliver project objectives.
Manage external suppliers (CRO/CDMO) to ensure project timelines and budgets are met and customer requirements (including FDA and EMA regulatory requirements) are satisfied while delivering invoX’s business goals.
Take overall responsibility for CMC coordination across development, GMP production, and release of Soft Mist Inhalation formulations and final drug products.
Drive the program across multiple project phases with little direction or supervision from Leadership.
Key Responsibilities
Provide CMC technical leadership for inhaled drug development programs from early phase to submission at approved CRO/CDMO partners and internally.
Develop experimental programs, work plans, and schedules to meet performance objectives.
Identify complex problems and propose effective solutions through testing methodology improvements.
Review test results, identify variance causes, and recommend corrective actions to achieve goals.
Prioritize assignments to meet project objectives and deadlines; adhere to 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 to ensure compliance with objectives and timelines.
Review and approve non-GMP and GMP documentation (methods, reports, protocols, manufacturing documents, specifications, and other relevant documents).
Prepare Requests for Proposals (RfP) and define work packages for relevant activities.
Select and approve suppliers for different program phases (including RM suppliers and CROs/CDMOs).
Support audits as a technical co-auditor.
Participate in pre-clinical and clinical trials as observer and facilitator of activities.
Skills, Knowledge and ExpertiseExperience / Skills
Essential
Solid experience as a CMC project coordinator / Project Technical Leader in drug development, medical device, or industrialisation within the Pharma Industry.
Substantial experience in technical management of pharmaceutical drug development programmes including formulation and clinical trials to regulatory approval, with close partnership across commercial, RandD, IP, legal, and finance functions.
Experience working to ISO13485 and 21 CFR Part 820.
Experience working under ICH Q8, Q9, and Q10 principles and QbD principles.
Excellent written and verbal communication skills; exemplary planning, analytical and problem-solving abilities.
Strong IT user skills and ability to undertake risk analysis and risk management.
Significant experience dealing with suppliers and customers at a technical level; superior presentation skills.
Desirable
Experience in delivering Soft Mist Inhaler combination products.
Experience in sterile product development / manufacture.
Qualifications
Degree qualification in a science or technology subject.
Why work at invoX?We get things done, we keep things simple and we are driven by the science. We are ambitious, so we work hard to create an environment where we can take smart risks. We want to be innovative, so we encourage debate and collaboration to challenge the usual way of doing things. We love our celebrations and socialising, which make invoX a fun and diverse place to work. And most of all, everyone has the opportunity to make a difference.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Information Technology
Industries
Pharmaceutical Manufacturing
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Negotiable