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Injectable Drug Product Process Development
il y a 1 mois
Your responsibilities?
- Technical expert in the establishment of robust, fit for purpose injectable drug product manufacturing processes from toxicology studies or first in human until BLA approval.
- Define and select drug product manufacturing processes and parameters for clinical manufacture.
- Cooperate with a wide range of internal and external stakeholders, including contract manufacturing organizations, as part of a project team.
- Design and execution of lab studies in relation to drug product development activities, capture and analyze data and author related documentation (write-ups, protocols, reports (e.g. filter selection and sizing, target fill volume assessment, compatibility assessments, clinical blinding, etc).
- Capture and analyze critical manufacturing process data for process understanding and process characterization.
- Perform process risk assessments.
- Design DP processes for sterile injectable drug products in liquid or lyophilized powder form, in vials, pre-filled syringes or as combination products.
- Define the investigational medicine product preparation process in clinical trials.
- Provide support to ensure timely manufacture of stability and clinical DP batches.
- Provide support to process performance qualification/validation. Ensure products are manufactured in accordance with the company quality system, cGMP and latest regulatory requirements.
- Provide support in the completion of the relevant sections of the CMC regulatory submissions and regulatory briefing documents and response to questions from authorities.
- Provide support in investigations of deviations and complaints related to DP quality.
- Support knowledge transfer from late phase development to commercial for validated DP processes.
- Contribute to develop the ways of working in the department.
Your profile?
- Scientific Master’s Degree
- Minimum 3-5 years experience in sterile liquid drug product development and/or manufacturing within the pharmaceutical industry
- Fluent in French and English
- Knowledge and technical experience in liquid drug product development and cGMP manufacturing under aseptic conditions (such as vial, cartridge and pre-filled syringe filling)
- Excellent communication, negotiation and team player skills
- Autonomous with good problem solving skills
- Investigation failure, process improvement, waste reduction, cost reduction
- Technical knowledge of sterile DP development covering DP components, process transfer, scale-up and optimization is an advantage
- Knowledge in regulatory requirement is an advantage
- Understanding of biologicals drug product manufacturing process and scale-up is an advantage.
Our offer?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [emailprotected]
