We are seeking an experienced and dynamic Project Leader to oversee a team responsible for progression of Veterinary therapeutic antibody projects from discovery to proof-of-concept and guide a cross-functional team involved in the development and registration of monoclonal antibody products. The Project Leader will also be responsible for coordinating activities and interaction with outside partners including CROs and CDMOs and ensuring the successful execution of project objectives within defined timelines and regulatory compliance. This role requires strong leadership, competent project management, and expertise in the biopharmaceutical industry, particularly in monoclonal antibody development.
Provide overall leadership and strategic direction to the project team throughout the progression of antibody projects from discovery to proof-of-concept. Coordinate and collaborate with cross-functional teams, including R&D, process development, manufacturing, quality, regulatory affairs, clinical development, and commercialization, to align project goals and timelines. Develop and maintain detailed project plans, including milestones, deliverables, timelines, and resource allocation. Monitor and track project progress and make necessary adjustments to ensure adherence to project timelines, budget, and quality standards. Foster effective communication and collaboration within the project team and with stakeholders, including regular updates, meetings, and presentations. Collaborate with external partners, contract research organizations (CROs), and contract manufacturing organizations (CMOs) as needed. Stay updated on the latest developments and industry trends related to monoclonal antibody development and registration. Provide guidance, mentorship, and support to direct reports and team members, fostering a collaborative and high-performing work environment.
Education Minimum Requirement:
Required skills and experiences:
A solid scientific foundation in biotechnology, biochemistry, or a related field with minimum 7 years of experience in a field relevant to antibody therapeutics.
Understanding of the principles and intricacies of monoclonal antibody development, including antibody engineering, cell line development, biomolecular/cellular interaction assays, and analytical characterization.
Ability to interpret and analyze data from key biological, biochemical and immunological assay systems and design appropriate follow-on experiments
The ability to develop and manage project plans, set clear objectives and timelines, and allocate resources effectively.
Excellent interpersonal and communication skills.
Strong problem-solving skills and decision-making abilities including the ability to analyze complex data, identify potential issues or risks, develop contingency plans, and drive solutions to keep the projects on track. T
he ability to collaborate effectively with cross-functional teams.
Strong drive for results and a focus on meeting project objectives.
The ability to adapt to changing circumstances, learn quickly, stay updated on the latest scientific and technical advancements, and apply new knowledge effectively.
Advantageous skills and experiences:
10 years of experience, particularly working on key aspects of therapeutic monoclonal antibody discovery and/or development. Creativity and a proven track record will be an advantage. Experience in working effectively with external partners such as CROs and CDMOs engaged in development and registration of therapeutic proteins/antibodies. Familiarity with guidelines and requirements governing monoclonal antibody registration is an asset.
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