Associate Director R&D

Job Description

Responsibilties

• Provide input to the scientific strategic direction of the department, including influencing the mission, vision, and culture of the organization in alignment with department/company goals
• Identify best practices directly impacting functional deliverables, and leverage resources to capitalize on them.
• Create and encourage a transparent and trustworthy work environment.
• Promote the culture that "Quality is everyone's responsibility"
• Review RFPs, assist with providing information for the analytical portion of proposal, participate in customer visits, audits, or project meetings
• Ensure both initial and continued personal training is carried out and adapted according to need, and ensure that all employees are suitably trained in all processes before undertaking tasks
• Assist scientific staff in reaching appropriate critical decisions which align with current functional or cross-functional strategies
• Ensure high quality in analytical work and GMP compliance: accurate documentation, instrument qualification, software validation, training, sample handling, testing, record keeping
• Oversee the development/improvement and validation of robust analytical methods that are GMP-friendly based on quality-by-design and document formal protocols and reports.
• Oversee method transfer activities, including writing protocols and reports as needed.
• Establishment and qualification of GMP-compliant analytical laboratories.
• Manage multiple projects requiring analytical or process-related activities.
• Review experimental data, notebooks, and instrument qualification protocols/reports as needed
• Actively participate in investigations, problem-solving, and troubleshooting. Assisting with investigation reports.
• Prepare and present data summaries (written and oral) as necessary. Present to cross-functional teams and effectively communicate critical analytical issues and solutions.
• Direct the development of SOPs appropriate for CDMO activities.
• Communicate openly within the group to provide and gather information, to optimize the use of resources, and to optimize efficiency.

Education and Experience:

• PhD with 10+ years of experience in pharmaceutical analysis with 5+ years of management experience.
• Ability to effectively lead and supervise staff
• Proven technical skills in analytical method development and validation of small molecules
• Proven scientific skill and ability to oversee complex scientific work
• Effective in managing multiple competing activities and delivering to timelines
• Highly commercially oriented, able to demonstrate how delivery excellence can create competitive advantage to deliver and sustain business growth
• Highly organized, but flexible to changing priorities
• Ability to work in a cross-functional environment
• High level of awareness to innovative technologies and ability to adapt to in-house needs
• Broad experience in analytical instrumentation and selected higher end laboratory techniques.
• Ability to contribute to multi-disciplinary scientific teams
• Ability to drive continuous improvement
• Working knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidance
• Excellent communication skills, both verbal and written