We are currently seeking a Principal Process Development Scientist for a client in Durham, NC. The successful candidate will be responsible for developing and implementing robust manufacturing processes for small molecule drugs. We are looking for a seasoned, technical leader to join as an individual contributor and oversee the cGMP manufacturing process. The ideal candidate will have 8+ years of experience in the pharmaceutical industry.
Responsibilities:
* Develop and implement robust manufacturing processes for small molecule drugs
* Work with cross-functional teams to ensure that processes are optimized and meet the needs of the business
* Ensure that processes are compliant with GMP requirements for manufacturing facilities and equipment
* Work with external partners to perform tech transfer of drug product, medical device, or combination product manufacturing processes
* Provide technical expertise to support the development of new products
* Manage multiple projects simultaneously
Qualifications:
* Small molecule, drug process development experience
* GMP manufacturing process validation experience
* In-depth knowledge of GMP compliance requirements for manufacturing facilities and equipment for the production/packaging of drug product or drug led combination product - either EU requirements or US requirements
* Experience working in classified manufacturing spaces
* Excellent verbal communication skills
Preferred Skills:
* Experience with solid dosage forms, hot melt extrusion, modified release dosage forms, sterile products
* Experience with tech transfer of drug product, medical device, or combination product manufacturing processes
