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发帖数: 2761 | 1 JOB DESCRIPTION
Title: Principal Scientist / Manager
Department: Pharmaceutical
Report To: Senior Director
Subordinate: Undetermined
Requirements:
Education: 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.
Experience: 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.
Experiences in technical transfer, process validation and/or NDA
registration in big Pharma is a plus.
Skills: Proficiency in English (written and oral).
Excellent interpersonal, supervisory, investigative, and implementation
skills.
Possess excellent written and verbal communication skills. Requires the
ability to prepare and review technical reports.
Fluent in written and oral English.
Personality: Mature, confident and strong sense of
responsibility
Job 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. |
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