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

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

Qualification:

• 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

• Remote work 1 to 2 days per week or 1 week per month on site

• Travel activity within Europe (on average every 2 months)

Requirements:

Start : 07.01.2026