Manager CMC, Injectable Drug Product Development

Location: Lyon, France

Reporting to the Vice President CMC based in France, the CMC (Chemistry Manufacturing and Controls) Manager will take responsibility for Drug Product design, development, manufacture and control to support Alexion clinical development programs from early project up to Process Validation activities following company strategies and corporate objectives.

Key activities:

1. Design, conduct and coordinate development and optimization of Drug Product Formulation
2. Provide technical expertise/scientific input on formulation development strategies and formulation solution to develop phase-appropriate drug product for preclinical, clinical and future commercial use
3. Execute drug product formulation and process development including characterization of the process and finished product.
4. Participates in developing drug product development and delivery strategies through internal/external partnerships as well as product integration into drug/device combination products
5. Investigate, troubleshoot, and resolve formulation and process related issues from development and throughout clinical studies
6. Act as technical interface to guide CRO/CDMO to design formulation and manufacture Alexion drug product
7. Provides onsite support during production/transfer at CMOs to ensure overall compliance, appropriate resolution to critical issues, and timely progress updates.
8. Develop finished product specifications and ensure product compliance
9. Author/review drug product development reports and related sections in IND and NDA filing
10. Collaborate with QA functions and associated functions to ensure implementation of highest possible quality standards throughout manufacturing and process development impacting drug products
11. Participate in cross-functional process risk analysis using appropriate tools such as FMEA, leading to the identification of CPPs and CQAs
12. Ensure consistency, completeness, accuracy, and adherence to regulations and applicable guidelines (ICH, GMP, ISO, etc.)
13. Support technology transfer, review of master batch records, change control process, technical manufacturing deviation investigations, and review of executed batch records.
14. Develop project scopes, deliverables, budget, milestones, resources, and timelines with project leaders/managers to deliver successful CMC package
15. Maintain accountability for project success and results delivery
16. Communicate research and development findings internally and externally

Qualifications:

1. PhD in pharmaceutics, chemistry, material science with 2-4 years or M.S. with 6-8 years of relevant CMC development experience and a deep understanding of pharmaceutical sciences
2. Experience in parenteral formulation/delivery at various stages of development
3. Experience in managing and working with CROs and CDMOs
4. In-depth knowledge of cGMPs and familiarity with US and EU regulations and quality standards applicable to build CMC dossier (IND and NDA) for regulatory submissions
5. Demonstrated technical aptitude working on complex problems with creative problem solving and application of experimental design
6. Ability to manage projects in a fast-paced environment and effectively collaborate in a dynamic, cross-functional environment
7. Experience leading a team of scientists and engineers, ensuring their individual and organizational development
8. Strong organizational skills and attention to detail and accuracy
9. Excellent written and verbal communication skills and ability to communicate and present results and ideas to upper-level management in a clear, concise, and timely manner