Scientist

• Providing hands-on scientific and technical leadership in process insourcing, technology transfer, scale-up, and validation activities
• Coordinating upstream process development, optimization, and industrialization activities with internal R&D teams and external CMOs
• Leading lifecycle management activities for commercial biotech processes, ensuring continuous improvement, process robustness, compliance, and supply reliability
• Assessing and interpreting complex scientific data to support decision-making, risk mitigation, resource allocation, and program strategy
• Applying and promoting Quality by Design (QbD) principles and contributing to process characterization, control strategies, and validation plans
• Supporting regulatory submissions (MAA, NDA, BLA, JNDA)
• Designing, executing, and evaluating pilot-scale studies to support process development, optimization, scale-up, and technology transfer activities
• Collaborating with Production, Quality, Engineering, and Maintenance functions to support feasibility studies, validation campaigns, equipment qualification (IQ/OQ/PQ), and commercial process implementation
• Supporting the development of GMP documentation, including batch records, risk assessments, validation protocols, and technical reports
• Delivering theoretical and practical training to Manufacturing personnel

Lead Scientist driving biopharmaceutical processes at Chiesi

Lead Scientist, Upstream Biological Process

Lead Scientist focusing on industrialization and lifecycle management of biopharmaceutical processes at Chiesi. Requires strong scientific expertise and hands-on leadership in biotechnological environments.

• Identify national, regional, and local Key Opinion Leaders (KOLs) involved in the provision of cardiovascular care within institutional care centres and engage them in proactive and reactive scientific exchange
• Maintain and enhance existing scientific collaboration and professional relationships with hospital-based HCPs within a defined geography (physicians, genetic counselors, hospital teams, investigators, etc..) involved in the therapeutic management of patients with cardiac diseases to expand research, advisory, and educational partnership opportunities; identify areas of unmet medical need; and assure thoughtful exchange of current medical information related to products in development and therapeutic areas of importance
• Serve as a scientific expert at key medical and scientific conferences, clinical investigator meetings, internal meetings, and patient advocacy group meetings
• Maintain a high-level of scientific knowledge and understanding about disease state, underlying science, treatment guidelines, available treatment agents and options, as well as other relevant therapies under development
• Maintain a superior understanding of current trends in clinical research, competitive developments, patient care, and their impact on Cytokinetics’ medical strategies
• Ensure prompt intake and responses for medical information, requests for Medical Affairs support and PV. Work with Medical Affairs and other internal colleagues on initiatives including medical information, publications, medical education, grants, speaker training, and other educational programs both within the country and internationally
• Generate Field Medical Affairs plans to identify collaborative opportunities with KOL’s and institutions, review scientific program of relevant conferences, attend sessions, support exhibit booth operations, and contribute to a timely written conference report summarizing key information, activities, and competitive intelligence to colleagues
• Provide support to our clinical development programs by serving as a key point of contact for company-sponsored trial investigators, investigator-initiated research, and registries consistent with company objectives and regulations
• Support and collaborate with the Local Sales Team in alignment with the Medical Plan and local requirements
• Contribute to build up the Account Planning by providing to the local Sales Team the required medical insights
• Provide initial and ongoing disease and product training to internal and field personnel. Identify congresses and scientific national and international meetings that are interesting and relevant to attend. Review scientific program of relevant conferences, attend sessions, support exhibit booth operations, and contribute to a timely written conference report summarizing key information, activities, and competitive intelligence to colleagues
• Accurate and timely documentation of activities within applicable company databases and platforms
• In addition to above, for Senior Therapeutic Medical Scientist: Mentor, train and support other Therapeutic Medical Scientists
• Provide scientific training on key relevant data to Key Account Managers and other business colleagues as required
• Provide strategic input and execute region-specific plans to achieve KOL engagement goals and Medical Affairs departmental goals
• Pursue projects independently with a high degree of quality and timely execution
• Contribute to / lead Congress Planning activities
• Maintain a complete awareness of and understanding about current “real world” clinical practices, HEOR drivers, and emerging trends in treatments/medicine
• Establish relationships with key executive leadership colleagues across Cytokinetics and connect external parties with appropriate leadership team members

Therapeutic Medical Scientist providing scientific expertise in cardiovascular therapeutic area

Therapeutic Medical Scientist

Therapeutic Medical Scientist providing scientific expertise in cardiovascular therapeutic area for Cytokinetics. Engaging with healthcare providers and contributing to medical strategies addressing cardiac diseases.

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Lead Scientist, Upstream Biological Process

Therapeutic Medical Scientist