Freelance/contract cmc process validation - project lead consultant

Company profile


For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.


The Project


We are currently partnering with a leading Life-sciences group within the Angers/Nantes area France with support across a range of positions. At present we are looking to collaborate with an independent freelance/contract “CMC Process Validation – Project Lead” for at least 6 months for 40 hours per week assignment. This project is to be performed onsite in the Angers/Nantes area; it will commence ideally in the middle of August/start of September at latest and key is substantial skills working with sterile projects with fluency in French and English being a must.


Responsibilities


* Identifying and consolidating project information to support CMC section of client regulatory filings
* Develop and execute process validation protocols
* Transform CMC information into reports
* Support Technology Transfer
* Lead Process Validation Activities & Oversee Process Performance, Qualification (PPQ), Process validation strategies etc.
* Technical documentation management
* Overall support as an SME for CMC process development activities


Skills required


* At least a BSc or higher with a life-sciences discipline or Chemistry (or related job experience with a BSc)
* Must have a distinct and demonstrated background working in CMC Process Validation with sterile products
* Excellent knowledge of key regulations within the EU and ideally globally
* Fluent in English and French
* Can work office based in the Angers/Nantes area throughout the project
* Strong problem solving skills and attention to detail


Additional Information


We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.**