Head of Laboratory (m/f)

REFERENZNUMMER:

252654/9

IHRE AUFGABEN:

-Ability to handle multiple tasks and work in a highly matrixed environment.
-Designs, develops, executes, and evaluates experiments, studies and research programs to achieve project objectives.
-Develops project plans that are aligned with project goals.
-Supports drug product projects at all stages from lab to commercialization including feasibility, process development, design, and scale-up for complex parenteral formulations.
-Prepares and ensures thorough and accurate supporting documentation and reports for scale up from lab scale to commercial processes.
-Ensures the proper documentation, review, and analysis of experimental activities, observations, data, and results.
-Follows SOPs and GMPs.
-Interacts and communicates effectively with project managers, project team members, and clients on technical aspects of the project.
-Strengthens core technology and develops new technologies.
-May train, supervise, and develop other scientists and engineers in the execution of sound experimental design, data analysis, and other project tasks, as appropriate.
-Promotes and maintains a safe workplace environment.

IHRE QUALIFIKATIONEN:

-BS/BA in Chemical, Mechanical, Biomedical, or Electrical engineering or other relevant scientific discipline with greater than 9 yrs experience in the pharmaceutical industry; or, a MS degree in a relevant engineering or scientific discipline with greater than 7 yrs experience in the pharmaceutical industry.
-Effective written and verbal communication skills; ability to clearly and effectively communicate observations, results, and outcomes to line management, project managers, project team members, and clients.
-Ability to:
-Perform work utilizing a computer for extended periods of time;
-Sit for extended periods of time without being able to leave the work area;
-Stand for extended periods of time without being able to leave the work area;
-Grasp objects utilizing the fingers (fine motor manipulation);
-Reach for objects above the head or below the waist;
-Stoop or crouch by bending at the waist or by bending the legs;
-Determine colors
-Knowledge of the use of personal protective equipment and safety protocols and practices related to working with or exposure to hazardous chemicals, including HPAPIs, that could potentially affect the health of the employee. Must be able to wear a respirator.
-Proficient in Word and Excel; Project, Visio, Access are a plus.
-High mechanical aptitude.
-Thorough knowledge of relevant scientific principles and theories as well as the capability to use and apply standard scientific procedures and techniques.
-Experience in DoE is a plus.
-General knowledge of several fields across the pharmaceutical product and formulation development process, drug delivery technologies, and analytical technologies.
-Scale-up experience with one or more solid or semi-solid parenteral formulations such as microspheres, implants, polymeric nanoparticles, lipid nanoparticles, liposomes, and micelles.
-Experience working in a cGMP environment or be able to quickly learn and apply cGMP principles; aseptic experience a plus.
-Thorough knowledge of pharmaceutical equipment for parenteral applications, experience writing URS's, and basic equipment design.
-Conduct assigned tasks with consideration to timelines and project goals/objectives under minimal supervision of senior engineering/scientific staff.
-Strong problem solving skills in a research and development environment; utilizes experience, scientific knowledge, and technical creativity to independently determine and propose approaches to overcome technical challenges.
-Works on multiple activities in parallel and multi-faceted research studies or programs with minimal supervision; may semi-independently manage research tasks of appropriate scope and complexity.
-Demonstrate a willingness and ability to share skills and information with others.
-Ability to train people and supervise laboratory or technical activities.

WEITERE QUALIFIKATIONEN:

Head of laboratory, Quality manager