Senior Manager, Pharmaceutical Research and Development

Job Summary

This role requires a confident leader to manage CMC projects and personnel effectively. The Senior Manager will execute strategic departmental targets, ensure top-tier quality standards, and foster a productive work environment. Responsibilities include leading and supervising development projects for formulations, analytical methods, product specifications, manufacturing processes, and all other CMC activities necessary for product development and regulatory submissions. This position also entails managing the Pharmaceutical R&D laboratory. The lab manager will inspire and motivate the team to achieve peak performance, requiring exceptional communication and interpersonal skills.

Responsibilities

• Initiate, lead, and manage projects with subcontractors for various tasks, including analytical method development, formulation development, manufacturing processes development, and preparation of preclinical formulations.
• Lead formulation development and analytical method development within the UroGen laboratory, in collaboration with analytical and formulation scientists.
• Manage the Pharmaceutical R&D laboratory team and laboratory work.
• Schedule and prioritize laboratory work in consultation with the VP, Pharmaceutical R&D.
• Ensure laboratory work complies with standard operating procedures (SOPs), including analytical testing, equipment maintenance, and safety.
• Verify lab work documentation in lab notebooks, ensuring real-time documentation and timely second signature verification.
• Ensure lab working instructions and SOPs are current and updated.
• Oversee laboratory work in compliance with health and safety requirements.
• Monitor the functioning and productivity of Pharmaceutical R&D Department resources, in collaboration with the VP, Pharmaceutical R&D.
• Ensure performance and analysis of stability tests for R&D formulations and drug products.
• Follow up and summarize stability results for UroGen products in commercial and clinical stages.
• Collaborate with the VP, Pharmaceutical R&D and project leaders to prioritize project performance and execute lab work as required.
• Issue expiration dates for products in clinical trials.
• Provide training and mentoring to analytical and formulation scientists.
• Ensure timely ordering of chemicals and materials for laboratory work.
• Collaborate with QA, RA, device, clinical, preclinical, and manufacturing departments.
• Author and review CMC sections for regulatory submissions.
• Propose, screen, and evaluate new formulations.
• Lead the design of formulation testing.
• Oversee the development of testing methods and SOP writing.
• Summarize and analyze testing results.
• Maintain detailed records of all work, processes, and projects.
• Write protocols and development reports.
• Conduct literature searches as needed.
• Participate in various forums, projects, and networking activities.
• Provide input on project planning.
• Oversee formulation preparation for preclinical testing.
  
  

• Minimum 10 years of experience managing CMC projects, including preclinical, clinical phases, IND and NDA submissions, and commercial stages.
• Extensive experience writing protocols, reports, and IND/NDA sections.
• Proven experience managing teams and pharmaceutical R&D laboratories.
• Creative thinker with the ability to excel in a fast-paced, matrix environment.
• Ability to design, execute, analyze, and report studies according to pharmaceutical requirements.
• Independent, team-oriented, and able to adapt to a multicultural working environment.
• Highly motivated with strong work ethics.
• Self-directed and able to multitask with keen attention to detail.
• Proficiency in English.
• Experience managing CMC projects involving proteins, viruses, and bacteria is an advantage.
  
  

• Strong leadership and team management skills.
• Excellent communication and interpersonal skills.
• Ability to think strategically and solve problems effectively.
• Strong organizational and time management skills.
• Knowledge of regulatory guidelines and CMC processes.
• Experience with specific software or equipment relevant to the role.