Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.
Vakante Jobangebote finden Sie unter Projekte.
Drug Product Development Manager
Eingestellt von Michael Bailey Associates - Munich
Gesuchte Skills: Engineering, Design
Projektbeschreibung
Job Description
PRIMARY ROLE:
Under the direction of the Product Development Senior Director, the Drug Product Development Manager is responsible for supporting the Drug Product Development Department with expertise in process development of new sterile drug products.
Responsibilities encompass all drug product related development activity such as formulation development, process development, manufacturing, scale-up, validation, process transfer, regulatory, stability, analytical and data review CMC development team leadership and representing CMC on cross-funtional teams.
Knowledge and previous experience with developing drug products is required.
Knowledge of active pharmaceutical ingredient development/scale-up and analytical method development/validation is desired.
CMC submission document author/reviewer experience is highly desired.
Ensures development of robust formulations and manufacturing processes through Quality by Design (QbD).
Manage ongong projects at CROs and provide project updates to management and project teams Supports selection and management of Shires contractors to achieve Shire's development goals and timelines.
EDUCATION & EXPERIENCE REQUIREMENTS:
Minimum of a Bachelors degree from college or university in Chemistry, Chemical Engineering, Pharmacy or closely related field.
Masters degree or PhD is preferred.
Generally has at least 13 years experience for BS, 10 years experience for MS or 8 years experience for a PhD in the Pharmaceutical Industry
Must have at least 7 years' experience in formulation/process development and/or manufacturing for clinical development candidates.
Experience in oral solid dosage forms is a plus.
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.
PRIMARY ROLE:
Under the direction of the Product Development Senior Director, the Drug Product Development Manager is responsible for supporting the Drug Product Development Department with expertise in process development of new sterile drug products.
Responsibilities encompass all drug product related development activity such as formulation development, process development, manufacturing, scale-up, validation, process transfer, regulatory, stability, analytical and data review CMC development team leadership and representing CMC on cross-funtional teams.
Knowledge and previous experience with developing drug products is required.
Knowledge of active pharmaceutical ingredient development/scale-up and analytical method development/validation is desired.
CMC submission document author/reviewer experience is highly desired.
Ensures development of robust formulations and manufacturing processes through Quality by Design (QbD).
Manage ongong projects at CROs and provide project updates to management and project teams Supports selection and management of Shires contractors to achieve Shire's development goals and timelines.
EDUCATION & EXPERIENCE REQUIREMENTS:
Minimum of a Bachelors degree from college or university in Chemistry, Chemical Engineering, Pharmacy or closely related field.
Masters degree or PhD is preferred.
Generally has at least 13 years experience for BS, 10 years experience for MS or 8 years experience for a PhD in the Pharmaceutical Industry
Must have at least 7 years' experience in formulation/process development and/or manufacturing for clinical development candidates.
Experience in oral solid dosage forms is a plus.
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Medien/Design, Ingenieurwesen/Technik