at Incyte Corporation in Wilmington, Delaware, United States
Job Description
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 value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Our Global Pharmaceutical Development group is looking for an experienced scientist in topical formulations. The Associate Director, Pharmaceutical Development (Topical) is responsible for drug development activities for topical products and delivery systems. This role 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 Incyte's drug substances and NCE's
Assist with ongoing late stage clinical development of topical products
Write and review technical documentation for regulatory submissions
Establish external contracts with CMO's
Direct and/or perform hands-on laboratory work to develop topical dosage
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.
15+ years of experience developing topical and/or other dosage forms;
Skilled in the development of dermatological and ophthalmic drug products, including cream, gel, lotion, ointment, solution, (nano)emulsion, eye drops and suppository . 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.
Through knowledge in regulatory filings and hands-on experience in areas like analytical development, formulations development and drug device for drug product filings.
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 manufacturing.
Experience with authoring IND's/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.
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