Description
Director, Late-Stage Drug Product Development with Boehringer Ingelheim Animal Health USA, Inc. in North Brunswick, NJ (Telecommuting permitted : work may be performed within normal commuting distance from this office 40% of the time)
Job Duties : Provide leadership, training, and supervision of the local Late-Stage Drug Product Development (LSDPD) team plus complete and maintain Environmental, Health and Safety (EHS) and Good Manufacturing Practice (GMP) related trainings and ensure work place safety.
Ensure all LSDPD Science activities meet overall project timeline and proactively support Chemistry Manufacturing Control-Technical Development Team to ensure overall success of the assigned Development projects.
Responsibility for authoring and review of process development reports and major pharmaceutical submission documentation relating to process development as well as provision of responses to health authority questions.
Ensure execution of overall GMP campaign operation including secondary packaging for clinical trial supply, registration batch manufacturing and process development trials schedule and work packages.
Evaluate and implement new technologies for Drug Product manufacturing and control, including harmonization within Boehringer Ingelheim Animal Health manufacturing sites.
Telecommuting permitted : work may be performed within normal commuting distance from the Boehringer Ingelheim Animal Health USA, Inc.
office in North Brunswick, NJ 40% of the time.
Work Schedule : 40 hours per week (8 : 00am to 5 : 00pm)
Job Requirements : Doctorate degree (US or foreign equivalent) in Pharmaceutics, Chemistry, Chemical Engineering, or a related field and ten (10) years of experience in the job offered or in a related role OR Master's degree (US or foreign equivalent) in Pharmaceutics, Chemistry, Chemical Engineering, or a related field and twelve (12) years of experience in the job offered or in a related role.
- Must have eight (8) years of experience with drug product process development. Must have five (5) years of experience with : people management including direct supervision;
- utilizing understanding of U.S. pharmaceutical regulatory expectations (such as FDA) in the development of finished drug product processes and regulatory submissions;
- leading the interactions with pharmaceutical R&D and Manufacturing functions; developing solid oral dosage forms pharmaceuticals;
using statistical tools such as Minitab or Jump; and, working with external pharmaceutical service provider such as CRO or CDMO.
Must have three (3) years of experience participating in pharmaceutical internal governance structure. Must have two (2) years of experience directly managing budgets and allocating resources.
Must have experience completing one (1) full drug product development transfer into manufacturing. 20% domestic and international travel required.
Director, Late-Stage Drug Product Development
Director, Late-Stage Drug Product Development with Boehringer Ingelheim Animal Health USA, Inc. Job Duties: Provide leadership, training, and supervision of the local Late-Stage Drug Product Development (LSDPD) team plus complete and maintain Environmental, Health and Safety (EHS) and Good Manufactu...
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