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CMC Project Manager
For a late-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics. Our unique SIMPLE Antibody™ platform and suite of Fc engineering technologies combined with the complementary expertise of our people enabled us to build a clinical-stage portfolio of novel product candidates – tailored from discovery through development to address patient needs.
To further strengthen our Project Management team, we are looking for a talented CMC Project Manager. This position will occupy a key role supporting Chemistry, Manufacturing and Controls (CMC) development for our therapeutic antibodies, ensuring that projects successfully move forward within and across functions. You will perform planning, controlling, monitoring and reporting for assigned project in collaboration with the CMC Leads and the project teams. This includes CMC activities like process development, analytical development, product development, technical transfer, dossier development, clinical manufacturing and project strategy. The ideal candidate will be detail driven and have a proven track record driving project success within CMC in the pharma/biotech industry.
Key Accountabilities and Responsibilities:
- Responsible for achieving project goals, including timelines, budget, and scope.
- Translate the scientific strategy into a CMC project plan with support of the CMC leads for one or more drug development programs/projects, visualising timelines and dependencies between deliverables and define budget needs
- Track, monitor and report key milestones and decision points to drive delivery of projects in accordance with corporate objectives., balancing scope, cost, timelines and risk;
- Build strong working relationships with internal and external key stakeholders to to ensure timely completion of CMC activities by continuously monitoring progress;
- Perform critical path analysis and risks, taking into account cross-functional interdependencies in the overall development project plan;
- Coordinate on the delivery of those critical path items through prioritization setting where required and mitigate or escalate the risk together with the project team;
- Perform scenario simulations and advise on optimum development planning, as needed;
- Prepares and leads project team meetings including issuance of agent, actions and meeting minutes to be documented, communicated and committed.
- Establish project management best practices and assist in the implementation of infrastructure necessary for successful project management such.
- Promote a culture of collaboration, cooperation, execution excellence, effective communication, and cross-functional problem-solving to enable a high-performing team.
- Master degree in life-sciences;
- At minimum 5 years CMC project experience;
- Experience in working with biologics is a plus;
- Excellent planning and organizational skills, able to multi-task in a multicultural environment and prioritize,
- Strong analytical, problem solving and critical thinking skills with action-oriented follow through
- Experience working with CMC Teams and managing relationships with CMC vendors is strongly preferred and capable of building effective relationships
- Able to operate in a dynamic surrounding of a fast growing biotech company with challenging timelines;
- Quality conscious attitude;
- Demonstrated project management skills, responsiveness to issues, and passion for contributing to the development of new medicines
- Excellent communication skills
- A self-starter with the ability to work in a fast-paced environment and adapt quickly to changing needs and priorities;
- Fluent in English – their working language;
- A competitive salary package with extensive benefits
- Front seat in the development of therapeutic antibodies
- A work environment in a human-sized, dynamic and rapidly growing biotech company