Manager CMC Injectable Drug Product Development

Alexion Europe Company; Lyon; Sur place; EUR 60 000 - 100 000; Plein temps

Résumé du poste

An established industry player is seeking a CMC Manager to oversee drug product design and development. This role involves optimizing formulations, managing projects, and ensuring compliance with regulatory standards. The ideal candidate will have a strong background in pharmaceutical sciences, experience in parenteral formulation, and the ability to lead cross-functional teams. Join a forward-thinking company dedicated to advancing clinical development programs and making a significant impact in the pharmaceutical industry.

Qualifications

• PhD or MS in relevant fields with extensive CMC development experience.
• Strong knowledge of cGMPs and regulatory submission processes.

Responsabilités

• Lead drug product design and development for clinical programs.
• Collaborate with CROs and CDMOs for formulation and manufacturing.

Connaissances

Pharmaceutical Sciences

Formulation Development

Problem-Solving Skills

Project Management

Regulatory Compliance

Formation

PhD in Pharmaceutics

MS in Chemistry or Material Science

Outils

FMEA

Description du poste

Location: Lyon, France

Reporting to the Vice President of CMC based in France, the CMC (Chemistry, Manufacturing, and Controls) Manager will be responsible for drug product design, development, manufacturing, and control to support Alexion's clinical development programs, from early projects to process validation activities, aligning with company strategies and corporate objectives.

Key Activities:

1. Design, conduct, and coordinate the development and optimization of drug product formulation.
2. Provide technical expertise and scientific input on formulation development strategies and solutions to develop phase-appropriate drug products for preclinical, clinical, and future commercial use.
3. Execute drug product formulation and process development, including characterization of the process and finished product.
4. Participate in developing drug product development and delivery strategies through internal and external partnerships, as well as product integration into drug/device combination products.
5. Investigate, troubleshoot, and resolve formulation and process-related issues throughout development and clinical studies.
6. Act as a technical interface to guide CROs and CDMOs in designing formulation and manufacturing processes for Alexion drug products.
7. Provide onsite support during production and transfer at CMOs to ensure compliance, resolve critical issues, and provide timely updates.
8. Develop finished product specifications and ensure product compliance.
9. Author and review drug product development reports and related sections for IND and NDA filings.
10. Collaborate with QA and related functions to ensure high-quality standards in manufacturing and process development.
11. Participate in cross-functional process risk analysis using tools like FMEA to identify CPPs and CQAs.
12. Ensure adherence to regulations and guidelines such as ICH, GMP, ISO.
13. Support technology transfer, review of batch records, change control processes, deviation investigations, and batch record reviews.
14. Develop project scopes, deliverables, budgets, milestones, resources, and timelines with project leaders to ensure successful CMC package delivery.
15. Maintain accountability for project success and results.
16. Communicate R&D findings internally and externally.

Qualifications:

• PhD in pharmaceutics, chemistry, material science with 2-4 years, or MS with 6-8 years of relevant CMC development experience and a deep understanding of pharmaceutical sciences.
• Experience in parenteral formulation/delivery at various development stages.
• Experience managing and working with CROs and CDMOs.
• In-depth knowledge of cGMPs, familiar with US and EU regulations, and experience preparing CMC dossiers (IND and NDA) for regulatory submissions.
• Strong problem-solving skills, creative application of experimental design.
• Ability to manage projects in a fast-paced environment and collaborate effectively in a cross-functional team.
• Experience leading a team of scientists and engineers, fostering their development.
• Excellent organizational, communication, and presentation skills.

Date Posted: 15 Jan 2025

Note: The job description contains unrelated sections about employment policies, skills unrelated to pharmaceutical sciences, and other non-relevant details that should be removed for clarity and focus.