Head of R&D
Head of R&D
Primary Responsibilities:
As the Head of R&D of our cutting-edge Contract Development and Manufacturing Organization (CDMO), you will play a pivotal role in shaping the scientific and technical direction. Your leadership will be instrumental in driving innovation, ensuring quality, and building strong client relationships.
Key Functions:
Strategic Leadership:
- Develop and execute a comprehensive scientific and technical strategy aligned with the company's values of teamwork, commitment, determination, and efficiency.
- Lead and execute strategies supporting Business Development, Process and Analytical Development, and Regulatory Compliance, in collaboration with Sales and Project Management.
Technical Excellence and Process/Analytical Development:
- Provide expertise in the development and characterization of processes of recombinant proteins and mRNA, incorporating statistical knowledge where applicable.
- Provide expertise in a broad panel of analytical methods to characterize a biologic at diferent stages of the development and from an orthogonal point of view.
- Lead the entire development area, encompassing Process Development and Analytical Development, adhering to sales and project management guidelines, as well as regulatory standards.
- Provide an excellent knowledge of the Quality by Design principles
Problem Resolution and Representation:
- Address day-to-day technical challenges in development department, including early stage projects
- Represent the company at client meetings, conferences, and exhibitions, showcasing technical prowess.
Strategic Network Building:
- Establish a network with key stakeholders in public, academic, and private entities to enhance the company's capabilities.
- Actively contribute to expanding the company's services through the adoption of new technologies.
- Contribute to built in a comprehensive understanding of the constantly evolving biologics CDMOs landscape
CMC Support and Leadership:
- Serve as the primary contact for all CMC activities, offering support to clients and ensuring regulatory compliance.
- Lead a team of 20 individuals with a focus on scientific excellence and motivation.
Budgeting and Strategic Planning:
- Define and prepare department budgets, investment plans, and long-term visions.
- Drive the adoption of new technologies, ensuring the continuous development of the company's service pipeline.
Scientific Expertise:
- Demonstrate exceptional scientific leadership with high-level knowledge in molecular biology, cell banks, USP, DSP, and Analytical Development.
- Provide expertise in diferent expression Systems such as E. Coli, P. Pastoris, CHO, HEK
- Provide expertise in the field of plasmid DNA and mRNA
- Provide expertise in purification and formulation of biologics
- Provide expertise in development and qualification of analytical methods ranging from physicochemical, biochemistry and bioassays
- Possess good knowledge in scaling, tech transfer, QC, and industrial manufacturing.
Requirements:
- 7-10 years of managerial experience in recombinant protein expression and purification in CDMOs or the biopharmaceutical industry.
- Proven track record as a leader with a strong scientific background.
- Good knowledge of GMP regulations and quality standards.
- Strong team management and collaboration skills.
Education:
Candidates for the role of Head of R&D should hold a Bachelor's degree or its equivalent in biological sciences, pharmaceuticals, or a closely related field. Advanced degrees such as Master's or Ph. D. are highly preferred, demonstrating a commitment to continuous learning and specialized knowledge.
Send your CV at contact@leanbiopro.com
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