LSNE is a leading pharmaceutical Contract Development Manufacturing Organization (CDMO) that specializes in aseptic and non-aseptic fill / finish and lyophilization of biologic drugs, small molecules, suspensions, oily and aqueous solutions, in a wide range of different presentations glass vials, prefilled syringes and ophthalmic bottles.
JOB DUTIES -
Evaluation of new active ingredients, excipients and conditioning materials.
Prepares protocols and reports for the galenic development of new products according to GMP and ICH regulations.
Prepare the formulation tests.
Design and elaborate pilot and transfer batches of new products to industrial production plant.
Design and elaborate the manufacturing guides for the new products.
Design and prepare the protocols and reports for the process validation of the new development and transfer products according to GMP and ICH regulations.
Keeps the equipment and facilities correctly qualified and the PNTs updated.
Perform their duties following the quality criteria set by the Company.
Perform the functions of your position according to the behavioral criteria established by the Securities Administration.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification.
They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.