Associate Director Analytical and Formulation Sciences

Durham, North Carolina
Apr 21, 2021
May 05, 2021
Organization Type
Kelly is actively recruiting for Associate Director Analytical and Formulation Science Direct Hire position in Greater Durham, NC.

Kelly is seeking an experienced and motivated Associate Director responsible for managing a group of 10-15 analysts and technical leaders. The individual will be responsible for directing and overseeing Quality Control (QC) activities, analytical test methods development and formulation development for biotherapeutics in partnership with external clients. Additional responsibilities include collaboration with Manufacturing and Quality Assurance departments to ensure proper integration of all project components. This role will report to Senior Director of Analytical and Formulation Sciences.

Job Responsibilities:
  • Direct quality control activities including method transfer, qualification and validation, Drug Substance and Drug Product release and stability testing for clinical and commercial products
  • Work closely with Analytical Development, Manufacturing and Quality Assurance teams in support of internal manufacturing
  • Lead laboratory investigations, implementation of the corrective and preventive actions, and ensure proper change management
  • Fully responsible for the direction of all assigned analytical and formulation activities
  • Provide guidance to design and develop analytical test methods and provide creative technical problem-solving options
  • Lead formulation development activities to design stable formulations by identifying critical factors in both, one factor at a time and statistical analyses
  • Provide oversight of review and approval of analytical test methods, study protocols and technical reports
  • Develop and maintain budgets, manpower and capital requirements for formulation/ analytical areas
  • Develop preliminary schedules along with material/ personnel/ equipment requirements to allow accurate contract pricing and appropriate performance guarantees
  • Provide facility expansion support as needed by Facilities Engineering to meet expansion timeline and cost requirements
  • In cooperation with customer representatives, identify process improvements in all laboratory areas
  • Lead and develop talent. Promote and develop professional growth of team and operational excellence
  • Develop and monitor performance criteria to allow measurement and continuous improvement of efficiency and quality

Minimum Requirements:
  • Bachelor of Science Degree with a minimum of 15 years of experience; a Masters degree with 13 years of experience or a Doctorate degree and at least 8 years of experience in Biochemistry, Molecular Biology, Biopharmaceutical Development or related disciplines. Additionally, at least 5 years of experience serving in a relevant managerial capacity.
  • Must have knowledge of cGMP and biotechnology-derived product regulations.
  • Strong written and verbal communication skills
  • Excellent critical thinking and scientific skills, with a demonstrated ability to analyze, interpret, and clearly present complex data with conclusions and understanding of the impact to development strategy

Also requires a demonstrated track record in the follow key areas:
  • Strong knowledge of cGMP requirements
  • Attainment of aggressive growth and profit objectives
  • Strong orientation for Quality and Customer Service
  • Demonstrated level of respect for individuals
  • Demonstrated contribution to science in appropriate area
  • High level of integrity and personal responsibility
  • Record of innovation
  • Strong collaboration and team building skills

If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.

Why Kelly ® ?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly ®

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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