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http://biotech.fyicenter.com/jobs/99897628_Sr_Scientist_I_in_biotech.html
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Date: 21-Dec-2006
Sr Scientist I in biotech
DUTIES & RESPONSIBILITIES
Manage assigned analytical development projects from chemical process
development, formulation development to commercial products in method
development, validation and stability testing through regulatory
submission. Take analytical lead on the assigned projects and
participate in CMC team and cross-functional team to formulate
analytical and CMC strategy for product development. Coordinate and
manage internal and external resources to develop and validate
analytical methods for assigned projects. Coordinate technology
transfer of analytical methods to internal and external customers.
Review and determine the acceptance of analytical work in terms of
accuracy and consistency in compliance with FDA, ICH guidelines and
SOPs to sup****t regulatory submissions. Develop analytical methodology
for small molecules development projects, and validate methods in
accordance with SOPs and cGMP. Prepare and review relevant SOPs,
protocols, validation and stability re****ts, and analytical section of
CMC submission to sup****t laboratory GMP functions and FDA submissions.
QUALIFICATIONS
Qualified candidates should possess a B.Sc., M.Sc. or Ph.D. degree in
chemistry or a closely related field with minimum 10, 8 or 5 years
experience, respectively, in a pharmaceutical analytical laboratory and
2-3 years supervisory or management experience necessary. In addition,
this leader****p position requires the core capabilities in both
technical and non-technical areas. Technical capabilities include, but
not limited to, proven experience in method development (HPLC, UV-Vis,
Dissolution, GC), method validation, method transfer, CRO management,
physical property testing (particle size, DSC/TGA, XRPD), stability
design/testing, CMC regulatory expertise, GLP/GMP compliance, strong
early and /or late stage product development experience. Non-technical
capabilities include, but not limited to, proven experience in managing
a group of 2-5 scientists, project management skills, effective
interface with drug substance and drug product development groups,
strong written and oral communication skills, resource management
skills and an influential team player in a cross-functional team.
Strong technical leader****p and communication skills in a team
environment and a high level of scientific judgment required. Advanced
experience in use of modern HPLC, GC, Dissolution (Type II and III) and
USP Methods to sup****t product development from early stage
(preclinical to Phase II) to late stage (Phase III and beyond) is
required. High level of expertise in cGMP, ICH and FDA guidelines as
applied to drug product development (drug substance and drug product)
is expected. Working experience in ICP/MS, particle size analyzer,
DSC/TGA, LC/MS and NMR is highly desirable.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
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