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.
About The Role
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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
Equal Employment Opportunity
Novartis is an equal opportunities employer and welcomes applications from all qualified candidates.
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