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Senior Manager Drug Product Development - St. Gallen, Schweiz - CSL
Beschreibung
CSL is a global biotherapeutics leader driven by its promise to save lives. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor –develops and delivers life-saving therapies to treat people with rare and serious medical conditions worldwide and employs 32,000 people.
For our CSL Vifor (Switzerland), we are looking for a
Senior Manager Drug Product Development
We offer a very exciting opportunity for a Senior Manager Drug Product Development to join the Chemical Product Development (CPD) Team whose primary focus is on drug substance, drug product, and analytical development in the area of small molecules.
The main responsibility of the role is to define, plan, and deliver packages to support drug product development projects spanning different stages including early stage and feasibility studies, clinical development, up to process validation, and market authorization.
To accomplish these objectives, the Senior Manager Drug Product Development will provide strategic direction, technical expertise, coordination, and oversight of CMC Science execution for a portfolio of projects including product development of injectables and solid oral forms.
The incumbent will work in close collaboration with Contract Development and Manufacturing Organizations (CDMO's) as well as CSL cross-functional Teams including representatives from Analytical Development, Quality, Regulatory Affairs, Clinical Supply, Toxicology, Pharmacokinetic, Technical Operation, and Manufacturing. You are an ideal fit for this position if you thrive in fast-evolving environments, like to be flexible and have a problem-solving mindset.
Role and Responsibilities:
· To manage formulation, process, and packaging development activities of New Chemical Entities (NCE's) drug products (parenteral aseptic solutions/suspensions and solid oral dosage forms) by collaborations with CDMO's as well as with internal resources
· To establish suitable DP development strategy including risk assessment and mitigation plans in collaboration with line manager, internal and external stakeholders and in line with the overall R&D, CMC and Clinical Development project plan, international guidelines and internal procedures
· To act as technical DP formulation and Process Development lead on project teams
· To monitor project plans and ensure milestones are met and deliverables becomes available in a timely manner
· To predict and highlight issues and criticalities and promptly inform about them the project manager and the rest of the team as well as the line manager
· To planning and implementing process improvement initiatives in support of CSL and industry best practices
· To plan and oversee the manufacturing of clinical trial supplies in compliance to cGMP and in line with clinical development plans
· To ensure the development of line extensions and new drug product development with third party companies as well as internal resources
· To apply Quality by Design principles appropriate to the drug product development stage and prepare related strategy and documentation in collaboration with technical development stakeholders and CSL dedicated team
· To plan, oversee and execute the PPQ with external partners and ensure the availability of pre-requisites for transferring the project to Technical Operations for commercial launch
· To support the preparation of submission files (IND, IMPD, NDA etc.) in accordance with overall project plan and to provide answers to HA questions in a timely manner
· To support cross functional teams to ensure projects are rolled out and delivered according to milestones, budget, and other relevant factors
· To coordinate site wide project activities with other sites/functions in global CSL network
Background Education and Past experiences:
· Ph.D., Masters, or BSc (or equivalent) in pharmacy and / or extensive experience in relevant discipline
· 5+ years' of pharmaceutical experience with demonstrated expertise in formulation and process development of NCE's (parenteral aseptic solutions/suspensions and solid oral dosage forms)
· Experience with process scale-up, robustness studies and QbD
· Experience with development of large volume parenterals and combination products
· Experience with regulatory issues related to pharmaceutical development
· Demonstrated success in project management and continuous improvement processes
· Good knowledge of Good Manufacturing Practices (cGMPs)
About CSL Vifor
CSL Vifor aims to become the global leader in iron deficiency and nephrology.
The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.
