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Associate Director Research Development

2 months ago

Providence, United States Germer International - Pharmaceutical Recruiting Full time

Our well-established pharmaceutical client is seeking an Associate Director of Research and Development to join their organization.You will 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