Job Description Summary
Create and drive with scientific & technological excellence the formulation development in close collaboration with operations, analytics, engineering and relevant SMEs, QA and the project DPPL. Development activities includes among others: formulation and process-design, control strategy, quality risk management, authoring of development documents and manufacturing instructions for technical and GMP manufacture incl. handling of deviation.
Job Description
Role Responsibilities:
- Lead the development of formulations and manufacturing processes of Drug Products
- Support the development and the qualification of analytical methods together with the AS&T team leader in accordance with ICHs guidelines and internal SOPs. Participate as formulation expert to cross-functional project teams.
- Be accountable for all formulation and manufacturing process deliverables incl. scientific documentation for all assigned projects (Manufacturing instructions, GMP documents, deviation..).
- Guarantee technical support answering DP related questions in inspections and Health Authority requests throughout all phases of the project life cycle.
- Participate to the transfer manufacturing procedures to the relevant department (e.g. Technical Operations, CDMO, etc.).
- Ensure authoring of accurate, comprehensible, structured, complete and legible documents to allow timely start of development trials, process transfers and supply activities.
- Draft the CMC documents required to enable regulatory submissions (IND/IMPD, Module3/NDA).
- Provide technical guidance to team members and work according to appropriate SOPs, GLP, GMP, HSE and AdAcAp / Novartis guidelines.
- Proactively communicate key issues and any other critical topic in a timely manner to the appropriate management level, to the TRD DPPL and/or to any other relevant project team member.
Essential Requirements:
- Minimum: PhD in Pharmaceutics or related sciences with a minimum of 3 years of proven experience within the pharmaceutical/biotech industry or a Master’s degree with a minimum of 5 years experience.
- Fluent knowledge of English (oral and written). Desirable knowledge of site language.
- Demonstrated success in developing formulations with an emphasis in liquid sterile dosage forms.
- Technical expertise and detailed understanding of drug product production and control technologies.
- Experience with outsourcing and supervising work done by CRO/CMOs including technical overview of agreement set up.
- Experience in writing CMC documents for regulatory submissions and responding to health authority questions.
- Good basis of Quality Assurance (overall knowledge of GxPs).
Work Experience:
- Functional Breadth.
- Operations Management and Execution.
- Collaborating across boundaries.
Skills:
- Environment.
- Experiments Design.
- Health And Safety (Ehs).
- Laboratory Equipment.
- Manufacturing Process.
- Materials Science.
- Process Simulation.
- Project Management.
- Sop (Standard Operating Procedure).
- Technical Writing.
Languages :
- English.
Skills Desired
Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Waterfall Model