Pharmaceutical Development

vor 1 Monat


Regio Basel Nordwestschweiz, Schweiz gloor & lang ag life science careers Vollzeit
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Your tasks:Responsible for pharmaceutical development and manufacturing of drug productsAssure clinical stage supplies in compliance with GMP and regulatory requirementsIdentify, evaluate and select appropriate pharmaceutical development and manufacturing organizationsContribute to implementation of contracts and technical agreementsSelect appropriate formulations and formulation technologiesOversee, manage and drive the outsourced pharmaceutical development, transfer and manufacturing activitiesProactively track project progress and critical path activities; review project risksDevelop formulation and process development strategies in alignment with the CMC teamReview and contribute to protocols for development, scale up manufacture, process validationCompile, review and contribute to reports and evaluate data provided by the CDMOReview batch documentation, assess deviations and contribute to batch release activitiesYour profile:PhD, MSc. Pharmaceutical Sciences or equivalent education> 5 years of experience in development and manufacturingExperience with sterile/parenteral drug product (bio)pharmaceuticalsExperience with biological compounds and biological drug product processes preferred.Experience in project management and/or collaboration with CMO/CROExperience in establishing regulatory documents (Drug Product part of IMPD/INDs, CTDs)This interactive position requires excellent communication skills and the ability to present convincing arguments on behalf of the project team to the Senior Management. You are used to utilize a variety of problem solving methods as well as to interface at a senior level with third parties and development partners. Travelling in the regions EU/USA shall represent up to 10-15% of your time. Mastery of the necessary “soft skills” to achieve high-performance teamwork for geographically dispersed partners is a key challenge of the position.

Interested? We are looking forward to get in touch with you.


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