Confidential/Princeton, NJ
CAPA, OOS, compliance, ANALYCHE, FDA, GMP, HPLC, ISO, METHODS, QC, RAW-MATL, VALIDCHE PHARMAC 15-10 Chemists (all types)
25-25 Quality Control, QA, Mgrs, etc
BS - Mandatory
MS
General Comments
Our growing biotech/device client is preparing for unprecedented growth!
Their product pipeline continues to expand.
The Analytical Services Manager will oversee contract analytical testing laboratories
and onsite laboratory operations. Will manage the development of new test methods,
validation and QC documentation. Must have compliance knowledge of FDA,
GMP/QSR, ISO 13485, the Medical Device Directive and other regulations.
Will manage testing and data review of all raw materials, components and products.
Education: BS chemistry or BIOCHEMISTRY; MS preferred
Requirements: Must have HPLC and GPC (gel permeation chromatography),
GC (head space analysis), moisture content and NMR experience.
5 plus years experience in a QC pharmaceutical environment with experience in commercial release and product development, OOS and CAPA review. ICH and 21 CFR Part 211 experience required. ISO 13485 experience a plus.
Apply To Job![]()
CAPA, OOS, compliance, ANALYCHE, FDA, GMP, HPLC, ISO, METHODS, QC, RAW-MATL, VALIDCHE PHARMAC 15-10 Chemists (all types)
25-25 Quality Control, QA, Mgrs, etc
BS - Mandatory
MS
General Comments
Our growing biotech/device client is preparing for unprecedented growth!
Their product pipeline continues to expand.
The Analytical Services Manager will oversee contract analytical testing laboratories
and onsite laboratory operations. Will manage the development of new test methods,
validation and QC documentation. Must have compliance knowledge of FDA,
GMP/QSR, ISO 13485, the Medical Device Directive and other regulations.
Will manage testing and data review of all raw materials, components and products.
Education: BS chemistry or BIOCHEMISTRY; MS preferred
Requirements: Must have HPLC and GPC (gel permeation chromatography),
GC (head space analysis), moisture content and NMR experience.
5 plus years experience in a QC pharmaceutical environment with experience in commercial release and product development, OOS and CAPA review. ICH and 21 CFR Part 211 experience required. ISO 13485 experience a plus.
Apply To Job
Source: Venture Beat