Principal Investigator, Pharmaceutical Development
Posted on: June 12, 2021
Incyte is a biopharmaceutical company focused on the discovery,
development, and commercialization of novel medicines to meet
serious unmet medical needs in oncology and inflammation and
autoimmunity. Incyte is committed to the rigorous pursuit of
research and development excellence to improve the lives of
patients, make a difference in health care, and build sustainable
The Company strives to discover and develop first-in-class and
best-in-class medicines-advancing a diverse portfolio of large and
Our Global Pharmaceutical Development group is looking for a
Principle Investigator responsible for drug development activities
for topical products and delivery systems. The Principal
Investigator will collaborate with colleagues in Quality Assurance,
Regulatory Affairs, Discovery and Clinical Development.
Essential Functions of the Job (Key responsibilities)
- Lead early stage topical product development of Incytes drug
substances and NCEs
- Assist with ongoing late stage clinical development of topical
- Write and review technical documentation for regulatory
- Establish external contracts with CMOs
- Direct and/or perform hands-on laboratory work to develop
- Handle GMP contract manufacturing organizations for clinical
drug product batches: the scope of the work may include review and
implementation of manufacturing batch records, SOPs, stability
protocols, and validation protocols.
Qualifications (Minimal acceptable level of education, work
experience, and competency)
- Must have at least a MS or Ph.D. in chemistry, pharmaceutical
sciences or other relevant field.
- 12+ years of experience developing topical and/or other dosage
- Skilled in the development of dermatological and ophthalmic
drug products, including cream, gel, lotion, ointment, solution,
(nano)emulsion, and eye drops. Experienced in excipient
compatibility studies for topical drug product development.
- Experienced in the In Vitro Release Testing and In Vitro
Permeation Testing, HPLC, viscosity and/or rheology, pH
measurement, moisture content, UV/Vis spectrometry; working
knowledge of LC-MS/MS, turbidity, size measurement, etc.
- Experience with other mucosal drug product development (oral,
nasal and GI) is a plus.
- Experienced in GMP, Industry and Regulatory requirements.
Walking knowledge in quality by design, critical quality attributes
and critical process parameters in pharmaceutical
- Experience with authoring INDs/NDA/MAAs.
Disclaimer: The above statements are intended to describe the
general nature and level of work performed by employees assigned to
this job. They are not intended to be an exhaustive list of all
duties, responsibilities, and qualifications. Management reserves
the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse
environment and is proud to be an equal opportunity employer.
We Respect Your Privacy
Learn more at:
Keywords: InCyte, Wilmington , Principal Investigator, Pharmaceutical Development, Other , Wilmington, Delaware
Didn't find what you're looking for? Search again!