at Incyte Corporation in Wilmington, Delaware, United States
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 a Staff Scientist, Pharmaceutical Development. This position provides pharmaceutical development support for assigned topical drug development programs.
Essential Functions of the Job (Key responsibilities)
Design and conduct experiments related to pre-formulation studies, formulation development, and process development of topical dosage forms including semisolids, foams and film formulations.
Provide hands-on support for drug excipient compatibility studies, design and prepare prototype formulations from lab scale to pilot scale with stability evaluation and process optimization utilizing DoE studies.
Experience with viscosity, rheology measurements, microstructure analysis of complex dosage forms and analytical skills including chromatography techniques.
Hands on experience with IVRT and IVPT studies for topical dosage forms with knowledge on method development and validation requirements.
Collaborate with cross functional teams including Analytical R&D, Quality Assurance, Regulatory affairs, Clinical planning, etc. to ensure robust drug product development to support clinical studies.
Provide assistance in overseeing formulation development and manufacturing of clinical and registration batches at selected CRO/CMO partners.
Authoring and review of documents related to project plans, product development reports, and documents prepared for submission to regulatory authorities. Maintain documentation as per cGMP and adhering to good laboratory practices and internal quality systems.
Ability to communicate technical reports with internal and external teams and strong computer skills with emphasis on Microsoft office, word, excel etc.
Self-starter with the proven ability to work in a team environment as well as independently while handling multiple projects and willingness to learn and expand their technical expertise in a motivated and fast paced environment.
Qualifications (Minimal acceptable level of education, work experience, and competency)
* B.S./M.S. in Pharmaceutical Science or equivalent experience.
* A minimum of 3-5 years of relevant pharmaceutical drug product development experience.
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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