职位描述
职位标签:
??formulation development
职位职能:
??生物工程/生物制药??其他
职位描述:
Responsibilities:
· Developing formulation strategies for IND and NDA in US and ROW, taking into account technical and regulatory considerations.
· Developing formulation manufacturing processes for both NDA registration and commercialization; organizing all activities associated with clinical batches and NDA batches.
· Creating, reviewing and/or approving technical documents (protocols, batch records, and development reports, etc.).
· Interacting with Manufacturing, Validation, and Materials Management to assure smooth technical transfer and scale up of formulations from development to commercial scale.
· Developing, interpreting and explaining standard practice instructions and procedures, and ensuring that they are complied with.
· Overseeing and/or collaborating with external parties involved with formulation development and/or manufacturing.
Qualifications:
· A science degree is required, preferably in Pharmaceutics or Chemistry. An advanced degree (Pharm D, Masters, or PhD in a science related discipline) is strongly preferred.
· Minimum of 5 years of experience with pharmaceutical development programs,preferably with NDA product development.
· Hands-on experiences in developing and manufacturing solid oral dosage product.
· Solid understanding of cGMP.
· Understanding of FDA,ICH and USP requirements for Drug Product development and manufacturing.
· Excellent interpersonal,supervisory, investigative, and implementation skills.
· Possess excellent written and verbal communication skills. Requires the ability to prepare and review technical reports.
· Experiences in technical transfer,process validation and/or NDA registration in big Pharma is a plus.
· Fluent in written and oral English.
