Consultant Technology Management Drug Product

Tasks

Advise teams for Site-Launch activities for internal and external sites (incl. lab units, SC, RACMC and QA)
Communicate with internal and external sites as part of the project
Review technical documentation (protocols, reports) associated with manufacturing, tech transfer, site-to-site transfers and PPQ as needed
Communicate and implement manufacturing plans at the site which are aligned with crossfunctional CMC strategic discussions
Communicates outcome of key meetings to stakeholders and functional areas
Conduct data review and analysis, data-driven decision-making process and support data transfer to the appropriate data repository - liaison between the Tech Strategy (data digitalization) and the site
Recommend remediations, CAPAs and provide inspection support as appropriate to mitigate risks or gaps
Participate in the CMC working group meetings and communicate clear, timely and detailed updates on tech transfers and site activities
Advice the compilation and technical review of relevant CMC sections of regulatory submissions (MAA), responses to regulatory questions, briefing books

Requirements

PhD (biochemistry, chemistry, pharmacy, engineering or related disciplines) or Master's degree with equivalent professional experience in pharmaceutical sciences preferable
Several years of experience in the pharmaceutical industry in a drug development environment
Extensive experience in CMC-related functions, including solid formulation processes and product development
Strong knowledge of CMC development, process development and technology transfer, CMC regulations and GMP compliance in the area of solid dosage forms
Strong verbal and written communication skills in English and the ability to work effectively with multinational teams in a multicultural work environment
Advise global project and cross-functional work teams (e.g.
zur Bewerbung →