Freelance Consultant Technology Management Drug Product (m/w/d)

Zu besetzendes Projekt: Freelance Consultant Technology Management Drug Product (m/w/d)
Branche: Biotech
Projektstart: 15.06.2024
Projektdauer: ca. 12 Monate
Auslastung: 3 - 5 Tage / Woche
Einsatzort: Großraum München, remote und vor Ort nach Absprache

Aufgaben:
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 (NDAs, BLAs, etc.), responses to regulatory questions, briefing books




Qualifikationen:
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. Site Launch Team). Advises CMC work group team in defining scope, assumptions and key objectives to enable effective risk management and ensure adherence to schedule
§ Influencing outcomes by negotiating win-win solutions