Manager - Biologics Drug Product Development -Limoges
- Experience Level
I'm looking for a manager, drug product development for supporting our client for development and scale-up of pharmaceutical client's products and processes. The role is a new one and will be an exciting opportunity to establish and manage the drug product development laboratory. A strong collaborator is needed to work effectively across functions at the site. The manager will need to relocate to Limoges, France
Activities, and Responsibilities:
- Manage a state of art scientific laboratory, maintain the laboratory instrument and continue to bring new technology in-house in the biologics drug product development.
- Leading a scientific team to conduct laboratory development work in a fast-paced project timeline.
- Apply technical, functional, business, and/or industry knowledge to design experiments/projects
- Provide scientific consultation across the biologics network. Actively contributes to the strategic direction of the biologics network by recommending expansion or curtailment of investigations on the basis of experimental results or scientific information.
- Collaborate on technical transfer and scale-up support with MS&T and operations.
- Support client visits and working teams.
- Review technical documents for accuracy, thoroughness and regulatory compliance
- Train, coach, and mentor others on technical, personal development or business issues
- Participate in or leads client meetings offering technical support and leading the project.
- Support development of business strategies and new technologies for multiple customers across multiple company sites
- Develop and administer training courses for biologics formulation development, including planning and leading workshops to help facilitate fundamental understanding of biologics degradation and formulation development strategy across the biologics network
- Routinely suggest new, innovative solutions to routine and complex problems
Typical Position Requirements:
- Ph.D. in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, and Chemical/Biological Engineering, or related scientific field with 3-5+ years of related industry experience
- MSc in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences and Chemical/Biological Engineering, or related scientific field with 8+ years of related industry experience
- Experience in manage a state of art scientific laboratory, maintain the laboratory instrument and continually bring new technology in-house in the biologics drug product development.
- Experience in people management with leading a scientific team.
- Experience in biologics formulation development, familiar with biologics formulation development strategies, and familiar with current industry best practice for sterile product development
- Experience in the biophysical method for biologics molecular structure characterization. Familiar with the relationship of biologics molecular structure to stability
- Experience develop analytical method characterizing degradation of biologics molecule, familiar with biologics drug product degradation mechanism
- Experience in the development of the fill-finish process of biologics including lyophilization cycle development and optimization. Familiar with the fill-finish process impact on the biologics product quality.
- Experience with preparation of regulatory documents such as, but not limited to, BLAs,
BLSs, INDs, briefing documents, and responses to questions from regulatory agencies
- Demonstrated problem-solving skills and written/verbal communication skills
- Ability to work independently within a team environment
- Demonstrated interpersonal skills to build relationships, act as a change agent, and adapt to rapidly changing organizational and business needs.
- 8-12+ years of experience related experience required and GMP experience preferred
Please send your CV via S.firstname.lastname@example.org
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