RLT Formulation Project Leader

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 ICH guidelines and internal SOPs. Participate as formulation expert in 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 in the transfer of 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 on 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.