Fast-track new product development project for small-molecule injectable. Delivered ambitious method validation and stability programme. Dossier preparation and review, response to authority questions.
Product quality issue. Systematic root cause investigation and data analysis carried out. Formulation change proposed and implemented. Presentation to senior management and regulatory body to get buy-in for approach.
Geographic expansion of legacy product. Dossier gap analysis and updates. Management of analytical CRO to carry out identification of new impurities and method update.
Process development for autologous cell culture. Identification of critical process parameters. Dossier update for clinical trial application.
Formulation development for oral dissolvable film and product transfer to CMO for manufacturing of clinical trial material. Project management. Dossier generation.
TECHNICALEXPERIENCE.
Drug substance: small molecules, peptides, biologics, cells
Drug product: injectables (solutions, emulsions, lyophilisates), solid dosage forms, oral dissolvable films
Extractables & Leachables. Related substances and elemental impurities.
DUEDILIGENCE.
Systematic review
and gap analysis
of technical information in seller's virtual data rooms. Compilation of key facts and figures.
Evaluation of project maturity and robustness. Risk identification and assessment. Estimation of Probability of Technical and Regulatory Success (PTRS).
Contributed to several successful transactions valued at more than $1.5bn.
INTERIMMANAGEMENT.
Short-term assignments to step in as functional manager and team leader upon departure of previous job holder or during times of transition
Experience with remote management and leadership for virtual teams
Change management and organisational development
Established competence mapping and gap analysis, set up personal development plans
OPENINNOVATION.
Change management project to re-invigorate innovation culture at large healthcare company
Set up of scouting and innovation teams. Facilitation of employee workshops to develop action plans.
Organisation of Innovation Challenge. Identification and evaluation of relevant start-up companies to participate.
