Kilo Lab Project Manager

Scope of the role:

Primarily responsible for managing the New Brunswick Kilo Lab facilities, scheduling, and manpower resources to support clinical and non-clinical API/Intermediates deliveries. Oversee the projects executed within the glass plant, comply with process safety, cGMP, and meet portfolio objectives. Collaborates and partners with chemical development teams and regulatory quality teams to safely meet portfolio objectives. Oversee implementation of new technologies and innovation platforms in the Kilo Lab.

Key responsibilities:

Will also have responsibilities for the implementation of chemical processes for drug candidates to support pharmaceutical development. Work hands-on with multidisciplinary teams from the Chemical Synthetic Development group to scale-up processes from the laboratory to the Kilo Lab.

Responsible for handling all activities involved in the scale-up of processes with strict adherence to safety, GMP and environmental regulations. Take the lead in coordinating and facilitation the campaign related activities in support of the production of GMP active drug substance that include but are not limited to the equipment selection, raw materials ordering, process safety evaluation, process design, recipe writing, process documentation, cleaning and process assessments.

Skills and qualifications:

• BS/MS/PhD Degree in chemistry or engineering
• Minimum of 7 years of experience with BS degree or 5 years with MS/PhD in chemical and/or pharmaceutical process development or manufacturing
• Demonstrated excellence leading matrix and cross-divisional teams
• Demonstrated commitment to safety
• Strong technical skills (chemistry, process development, chemical processing equipment), with a proficient understanding of GMP and safety regulations as required
• Candidates must possess excellent problem solving skills and be able to work effectively with multiple assignments
• Essential to success are the ability to build strong working relationships, to apply cooperation principles and ways of working in a matrix environment, and to lead matrix teams with the ability to effectively manage activities across a complex portfolio of projects with minimal supervision are essential