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

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

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