Selection of excipients and manufacturing processes to prepare prototype formulations which meet drug product requirements;Design and execute pre-formulation studies to support Product Development work;Design and execute formulation screening experiments using different types of components, technologies and using different statistical software;Design and execute formulation development studies within an R&D environment;Draft protocols and production batch records;Conduct technical risk assessment to identify risks and mitigation opportunities to enable successful development and scale-up to GMP Manufacturing Environment;Conduct formulation and process scale up activities to GMP environment;Document and report result of all experiments in a manner consistent with department practices and governing policies, as applicable;Generate, collect, interpret data sets and author reports and presentations, to share product knowledge and project progress with clients;Oversee GMP production and provide support as required;Provide scientific support in all aspects of formulation and drug product development;Work closely with Clients, Partners or CRO's in developing formulations and processes;Present data and actively participate in discussions on development activities, experimental design, etc;Participate in project updates for client's technical calls;Author and review protocols and development reports which will support Drug Product Dossier submission for global filings;Identify and troubleshoot process challenges during GMP batch execution and propose strategies for formulation and process improvements;Write SOPs, protocols and reports as required;Ensure that all work is performed within established key workflows and/ or regulations as described by SOPs, corporate policies and external regulatory guidance, as well as in compliance with the applicable cGMPs and GLPs;Give technical support to the Business Development team as required;Represent the Formulation Development function in cross-functional project teams and during client project meetings as required;Perform other related duties as required.M.Sc. or Ph.D. in relevant scientific discipline as Pharmaceutical, Chemical, Engineering or other related;Experience at least 3-5years real world development of pharmaceutical dosage forms experience (maybe as part of postgraduate education) in formulation and process development and scale-up and/or clinical manufacture;Familiarity with pharmaceutical industrial framework;Fluency in English (oral and written);Good computer skills (Microsoft Word, Excel and statistics-based programs);Strong time management and organization skills;Communication skills to develop good working relationships and to work effectively in a team environment;Strong analytical and problem-solving skills;Close attention to details and high commitment to quality;#J-18808-Ljbffr
