We are recruiting on behalf of a leading global pharmaceutical company with a strong history in developing innovative medicines. This client operates internationally and is known for its pioneering contributions in oncology and other specialty areas. They place great value on the highest CMC quality and the efficient transfer of new drug substances into commercial manufacturing at global sites.
As a Freelance Consultant, you will serve as the central technical expert for all aspects of technology management in the Drug Product (Solid Dosage Forms) area. You will take on a key role in ensuring compliance and the successful market launch of products at various internal and external production sites.
* Site Launch & Tech Transfer: Advise and guide teams for all Site-Launch activities (incl. lab units, SC, RACMC, and QA). This involves communicating and coordinating with internal and external sites.
* Technical Documentation & Compliance: Expert review and approval of technical documentation (protocols, reports) associated with manufacturing, tech transfer, site-to-site transfers, and Process Performance Qualification (PPQ).
* Strategic Manufacturing Planning: Communicate and implement manufacturing plans at the site which are aligned with cross-functional CMC strategic discussions.
* Data Liaison and Analysis: Conduct data review and analysis, support the data-driven decision-making process, and act as the liaison between the Tech Strategy (data digitalization) team and the site to support data transfer.
* Regulatory Consulting: Advise on the compilation and technical review of relevant CMC sections of regulatory submissions (NDAs, BLAs, etc.), responses to regulatory questions, and briefing books.
* Risk Mitigation: Recommend remediations and CAPAs and provide inspection support as appropriate to mitigate risks or gaps.
* Project Participation: Participate in CMC working group meetings and communicate clear, timely, and detailed updates on tech transfers and site activities to stakeholders.
* Academic Background: PhD (biochemistry, chemistry, pharmacy, engineering, or related disciplines) or a Master's degree with equivalent professional experience in pharmaceutical sciences.
* Industry Experience: Several years of experience in the pharmaceutical industry, specifically in a drug development environment.
* CMC Expertise: Extensive experience in CMC-related functions, including solid formulation processes and product development.
* Regulatory Knowledge: Strong knowledge of CMC development, process development, technology transfer, CMC regulations, and GMP compliance in the area of solid dosage forms.
* Soft Skills (Must-Have): Strong verbal and written communication skills in English. Proven ability to effectively advise, influence, and negotiate win-win solutions within multinational and cross-functional teams (e.g., Site Launch Team, CMC work group).
* Volume: Preferable 40 hours/week (but at least 30 hours/week).
* Duration: Long-term project
* Location: Remote work is possible (1 to 2 days per week or 1 week per month on site).
* Travel Activity: Yes, within Europe (on average every 2 months, e.g., to site locations).
* Attractive options for shortening your personal payment term
* No more time-consuming invoicing
* Fast, reliable payment of fees
* Conclude project contracts by means of electronic signature