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Associate Director, Analytical Development

4 months ago

Morristown, United States Bongene Search Full time

Bongene Search is biotech, pharmaceutical, and medical staffing agency that believes talent lies at the heart of all great companies. As such, the team at Bongene Search is dedicated to helping our clients around the globe create the most talented team of biopharma professionals. Whether it is a large publicly-traded company or a biotech start-up, our medical, pharmaceutical, and biotech recruiting agency will create a tailor-made search process that delivers the perfect fit for the role.


Our long term global healthcare client in Morristown, NJ is seeking an experienced Associate Director, Analytical Development. Relocation assistance is provided for the right candidate.


This pivotal role leads the analytical methods development and transformational science sub-department, ensuring the development and implementation of sound scientific approaches, accurate testing, and effective communication of results to the NPD project team.


Responsibilities:

  • Acts as a visionary, architect, coach, and catalyst (VACC) to teams thus driving NPD and transformational science projects;
  • Lead analytical development (AD) activities of differing complexities associated with new product development (NPD) for global markets. The activities include:
  • Method development;
  • Method validation;
  • Method transfer to manufacturing sites;
  • Stability studies planning;
  • Product specification preparation;
  • Serve as an analytical development subject matter expert within the R&D development center and represent AD on technical project teams;
  • Ensure all work processes comply with GMP and appropriate regulatory guidelines;
  • Develop and coach junior colleagues to enable professional development;
  • Work closely with the Director of AD to manage capacity, project budget, talent management and workload issues within the AD department;
  • Review SOPs, OIs and other relevant documents (e.g. validation/transfer protocols and reports);
  • Make recommendations on outside technologies for the company to pursue and conduct due diligences;
  • Effectively present experimental findings to colleagues with scientific and non-scientific backgrounds;
  • Identify AD related risks associated with NPD Projects and propose risk mitigation measures. Escalate the risks to management.


Requirements:

  • Bachelor’s Degree in Science or related degree;
  • Experience should be in the field of analytical development in the Rx, OTC or Consumer products industry or similar field;
  • Deep knowledge of relevant analytical techniques (HPLC, LC-MS, GC, UV-Vis, FT-IR, AAS), GMP, ICH and LIMS;
  • Ability to positively influence colleagues and key decision makers;
  • Excellent oral and written communication (emphasis on clear and concise), organizational, and interpersonal skills with the ability to multitask;
  • Self motivated to learn and develop within the organization.


Preferred Qualifications:

  • Bachelor’s Degree in Science or related degree with ten years of experience OR a Master’s degree in Science or related degree with six years of experience OR a Ph.D. in Science or related degree with four years of experience;
  • Two years of experience in leading a team of scientists (direct reports);
  • Record of publishing articles in reputed journals and presenting findings at conferences;
  • Experience in using statistical tools;
  • Project co-ordination experience;